aTyr Pharma（ATYR）株式概要臨床段階のバイオテクノロジー企業であるaTyr Pharma, Inc.は、米国において、tRNA合成酵素の生物学を線維症や炎症に対する新たな治療法に変換する製品候補の発見と開発に従事している。 詳細ATYR ファンダメンタル分析スノーフレーク・スコア評価4/6将来の成長0/6過去の実績0/6財務の健全性6/6配当金0/6報酬当社が推定した公正価値より96.5%で取引されている リスク分析収益が 100 万ドル未満 ( $190K )US市場と比較して、過去 3 か月間の株価の変動が非常に大きい現在は利益が出ておらず、今後3年間で利益が出る見込みはない 意味のある時価総額がありません ( $48M )すべてのリスクチェックを見るATYR Community Fair Values Create NarrativeSee what 69 others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair ValueUS$Current PriceUS$0.49483.3% 割高 内在価値ディスカウントEst. Revenue$PastFuture-130m10m2016201920222025202620282031Revenue US$2.5mEarnings US$446.9kAdvancedSet Fair ValueView all narrativesaTyr Pharma, Inc. 競合他社Senti Biosciences HoldingsSymbol: NasdaqCM:SNTIMarket cap: US$30.7mGain TherapeuticsSymbol: NasdaqGM:GANXMarket cap: US$75.9mKALA BIOSymbol: NasdaqCM:KALAMarket cap: US$45.2mInovio PharmaceuticalsSymbol: NasdaqCM:INOMarket cap: US$110.6m価格と性能株価の高値、安値、推移の概要aTyr Pharma過去の株価現在の株価US$0.4952週高値US$7.2952週安値US$0.40ベータ0.661ヶ月の変化-37.59%3ヶ月変化-50.44%1年変化-86.93%3年間の変化-79.15%5年間の変化-89.21%IPOからの変化-99.82%最新ニュースお知らせ • May 12aTyr Pharma, Inc. Provides Regulatory And Clinical Update For Efzofitimod In Pulmonary SarcoidosisaTyr Pharma, Inc. had announced the path forward for its lead therapeutic candidate, efzofitimod, in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD), following the receipt of the official meeting minutes from a Type C meeting with the U.S. Food and Drug Administration (FDA). The purpose of the meeting was to review the results of the Phase 3 EFZO-FIT study and determine the next steps for the program in pulmonary sarcoidosis. Based on feedback from the FDA, the Company plans to continue the development of efzofitimod in pulmonary sarcoidosis in a new Phase 3 study in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease utilizing forced vital capacity (FVC) as the primary endpoint of the study and the King’s Sarcoidosis Questionnaire (KSQ)-Lung score as the key secondary endpoint. The Company chose these endpoints based on the FDA’s indication that FVC and KSQ-Lung are direct measures of how patients suffering from pulmonary sarcoidosis function and feel, and the Company concluded FVC to be a more appropriate primary endpoint at this time pending further content validation work for the KSQ-Lung as recommended by the FDA. The Company plans to submit an investigational new drug (IND) application for this study in June 2026. Evidence from EFZO-FIT shows that patients with restrictive lung disease (defined as FVC percent predicted = 80%) experienced a clinically meaningful benefit for FVC when treated with efzofitimod compared to the observed decline in placebo. Furthermore, these more severe patients from EFZO-FIT also experienced positive trends of improvement across multiple patient-reported outcomes, including the KSQ-Lung score. As part of the discussion with the FDA regarding the benefit risk profile for efzofitimod, the Company plans to increase the frequency of dosing of 5.0 mg/kg efzofitimod or placebo from once every four weeks in past trials to once every three weeks in this next trial. Considering the consistent safety profile seen for efzofitimod in trials to date, the Company believes this strategy to increase drug exposure, coupled with additional risk mitigation strategies and safety surveillance, may enhance the effects of efzofitimod without incurring additional safety concerns. The Phase 3 trial is expected to be a global, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with moderate to severe pulmonary sarcoidosis. The 54-week study will consist of two parallel cohorts randomized equally to either 5.0 mg/kg efzofitimod or placebo dosed intravenously once every 3 weeks for a total of 17 doses. The study is intended to enroll up to approximately 372 patients with symptomatic pulmonary sarcoidosis with restrictive lung disease who are receiving a stable dose of = 5.0 mg daily oral corticosteroid (OCS) and/or a background immunosuppressant. All background treatment will remain stable throughout the duration of the study. The primary endpoint of the study will be change from baseline in FVC at week 48 and the key secondary endpoint will be change from baseline in the KSQ-Lung score at week 48. Efzofitimod is a novel biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. Efzofitimod is currently being investigated in the Phase 2 EFZO-CONNECT study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD, and aTyr intends to submit an investigational new drug (IND) application in June 2026 for a global Phase 3 study of efzofitimod in patients with pulmonary sarcoidosis, a major form of ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.分析記事 • Apr 17Is aTyr Pharma (NASDAQ:ATYR) In A Good Position To Invest In Growth?There's no doubt that money can be made by owning shares of unprofitable businesses. For example, biotech and mining...お知らせ • Mar 14aTyr Pharma, Inc., Annual General Meeting, May 11, 2026aTyr Pharma, Inc., Annual General Meeting, May 11, 2026. Location: 10240 sorrento valley road, ca 92121, san diego, United StatesBreakeven Date Change • Mar 06No longer forecast to breakevenThe 9 analysts covering aTyr Pharma no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$135.0m in 2028. New consensus forecast suggests the company will make a loss of US$64.0m in 2028.Major Estimate Revision • Feb 05Consensus revenue estimates increase by 21%The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$100.0k to US$120.0k. EPS estimate unchanged at -US$0.816. Biotechs industry in the US expected to see average net income decline 7.2% next year. Consensus price target of US$4.36 unchanged from last update. Share price fell 4.7% to US$0.81 over the past week.お知らせ • Feb 03aTyr Pharma, Inc. Announces Scheduling of FDA Type C Meeting to Discuss Efzofitimod Program in Pulmonary SarcoidosisaTyr Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's meeting request to discuss its lead therapeutic candidate, efzofitimod, for the treatment of pulmonary sarcoidosis. The Type C meeting is scheduled for mid-April 2026. EFZO-FIT was a Phase 3 study of efzof itimod in 268 patients with symptomatic pulmonary sarcoidosis. While the study did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid dose at week 48, clinical benefit for 5.0 mg/kg efzofitimOD was observed across multiple study efficacy parameters at week 48 compared to placebo, including improvement in change from baseline for the King's Sarcoidosis Questionnaire (KSQ) -Lung score (p=0.0479), Fatigue Assessment Scale score (p=0. 0226), KSQ-General Health score (p=0.0197), and complete steroid withdrawal with KSQ-Lung score improvement (p=0.0196).最新情報をもっと見るRecent updatesお知らせ • May 12aTyr Pharma, Inc. Provides Regulatory And Clinical Update For Efzofitimod In Pulmonary SarcoidosisaTyr Pharma, Inc. had announced the path forward for its lead therapeutic candidate, efzofitimod, in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD), following the receipt of the official meeting minutes from a Type C meeting with the U.S. Food and Drug Administration (FDA). The purpose of the meeting was to review the results of the Phase 3 EFZO-FIT study and determine the next steps for the program in pulmonary sarcoidosis. Based on feedback from the FDA, the Company plans to continue the development of efzofitimod in pulmonary sarcoidosis in a new Phase 3 study in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease utilizing forced vital capacity (FVC) as the primary endpoint of the study and the King’s Sarcoidosis Questionnaire (KSQ)-Lung score as the key secondary endpoint. The Company chose these endpoints based on the FDA’s indication that FVC and KSQ-Lung are direct measures of how patients suffering from pulmonary sarcoidosis function and feel, and the Company concluded FVC to be a more appropriate primary endpoint at this time pending further content validation work for the KSQ-Lung as recommended by the FDA. The Company plans to submit an investigational new drug (IND) application for this study in June 2026. Evidence from EFZO-FIT shows that patients with restrictive lung disease (defined as FVC percent predicted = 80%) experienced a clinically meaningful benefit for FVC when treated with efzofitimod compared to the observed decline in placebo. Furthermore, these more severe patients from EFZO-FIT also experienced positive trends of improvement across multiple patient-reported outcomes, including the KSQ-Lung score. As part of the discussion with the FDA regarding the benefit risk profile for efzofitimod, the Company plans to increase the frequency of dosing of 5.0 mg/kg efzofitimod or placebo from once every four weeks in past trials to once every three weeks in this next trial. Considering the consistent safety profile seen for efzofitimod in trials to date, the Company believes this strategy to increase drug exposure, coupled with additional risk mitigation strategies and safety surveillance, may enhance the effects of efzofitimod without incurring additional safety concerns. The Phase 3 trial is expected to be a global, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with moderate to severe pulmonary sarcoidosis. The 54-week study will consist of two parallel cohorts randomized equally to either 5.0 mg/kg efzofitimod or placebo dosed intravenously once every 3 weeks for a total of 17 doses. The study is intended to enroll up to approximately 372 patients with symptomatic pulmonary sarcoidosis with restrictive lung disease who are receiving a stable dose of = 5.0 mg daily oral corticosteroid (OCS) and/or a background immunosuppressant. All background treatment will remain stable throughout the duration of the study. The primary endpoint of the study will be change from baseline in FVC at week 48 and the key secondary endpoint will be change from baseline in the KSQ-Lung score at week 48. Efzofitimod is a novel biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. Efzofitimod is currently being investigated in the Phase 2 EFZO-CONNECT study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD, and aTyr intends to submit an investigational new drug (IND) application in June 2026 for a global Phase 3 study of efzofitimod in patients with pulmonary sarcoidosis, a major form of ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.分析記事 • Apr 17Is aTyr Pharma (NASDAQ:ATYR) In A Good Position To Invest In Growth?There's no doubt that money can be made by owning shares of unprofitable businesses. For example, biotech and mining...お知らせ • Mar 14aTyr Pharma, Inc., Annual General Meeting, May 11, 2026aTyr Pharma, Inc., Annual General Meeting, May 11, 2026. Location: 10240 sorrento valley road, ca 92121, san diego, United StatesBreakeven Date Change • Mar 06No longer forecast to breakevenThe 9 analysts covering aTyr Pharma no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$135.0m in 2028. New consensus forecast suggests the company will make a loss of US$64.0m in 2028.Major Estimate Revision • Feb 05Consensus revenue estimates increase by 21%The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$100.0k to US$120.0k. EPS estimate unchanged at -US$0.816. Biotechs industry in the US expected to see average net income decline 7.2% next year. Consensus price target of US$4.36 unchanged from last update. Share price fell 4.7% to US$0.81 over the past week.お知らせ • Feb 03aTyr Pharma, Inc. Announces Scheduling of FDA Type C Meeting to Discuss Efzofitimod Program in Pulmonary SarcoidosisaTyr Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's meeting request to discuss its lead therapeutic candidate, efzofitimod, for the treatment of pulmonary sarcoidosis. The Type C meeting is scheduled for mid-April 2026. EFZO-FIT was a Phase 3 study of efzof itimod in 268 patients with symptomatic pulmonary sarcoidosis. While the study did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid dose at week 48, clinical benefit for 5.0 mg/kg efzofitimOD was observed across multiple study efficacy parameters at week 48 compared to placebo, including improvement in change from baseline for the King's Sarcoidosis Questionnaire (KSQ) -Lung score (p=0.0479), Fatigue Assessment Scale score (p=0. 0226), KSQ-General Health score (p=0.0197), and complete steroid withdrawal with KSQ-Lung score improvement (p=0.0196).分析記事 • Dec 18Is aTyr Pharma (NASDAQ:ATYR) In A Good Position To Invest In Growth?We can readily understand why investors are attracted to unprofitable companies. For example, although Amazon.com made...お知らせ • Dec 06Atyr Pharma Receives Deficiency Notice for Non-Compliance with Nasdaq Listing RulesOn December 4, 2025, aTyr Pharma, Inc. received a deficiency notice (the “Notice”) from the listing qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that, for the last 30 consecutive business days preceding the date of the Notice, the bid price of the Company’s common stock had closed below $1.00 per share, the minimum closing bid price required by the continued listing requirements of Nasdaq Listing Rule 5550(a)(2). The Notice has no immediate effect on the listing of the Company’s common stock on The Nasdaq Capital Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 calendar days, or until June 2, 2026 (the “Compliance Date”) to regain compliance with the minimum bid price requirement by having shares of the Company’s common stock maintain a minimum closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days before the Compliance Date. If the Company’s common stock does not achieve compliance by the Compliance Date, the Company may be eligible for an additional 180-day period to regain compliance. To qualify for the second compliance period, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice to Nasdaq of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. However, if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible for the second compliance period, and the Company does not regain compliance by the Compliance Date, the Staff will provide written notification that the Company’s common stock is subject to delisting. At that time, the Company may appeal the delisting determination to a hearings panel pursuant to the procedures set forth in the applicable Nasdaq listing rules. However, there can be no assurance that, if the Company receives a delisting notice and appeals the delisting determination by Nasdaq to the panel, such appeal would be successful. The Company intends to actively monitor the closing bid price of its common stock between now and the Compliance Date and, as appropriate, will evaluate available options to resolve the deficiency and regain compliance with the minimum bid price requirement.Price Target Changed • Nov 14Price target increased by 8.9% to US$4.36Up from US$4.00, the current price target is an average from 7 analysts. New target price is 511% above last closing price of US$0.71. Stock is down 78% over the past year. The company is forecast to post a net loss per share of US$0.82 next year compared to a net loss per share of US$0.86 last year.お知らせ • Nov 12A New aTyr Pharma, Inc. Securities Class Filed; Class Period Significantly EnlargedA new class action complaint has been filed against aTyr Pharma, Inc. and certain of its top executives, significantly enlarging the alleged class period covered by the ongoing securities litigation. The new class action, Kingv. aTyr Pharma Inc., filed in the U.S. District Court for the Southern District of California on behalf of investors who suffered substantial losses, now seeks to represent all persons and entities who acquired aTyr Pharma securities between November 7, 2024, and September 12, 2025, inclusive. The previous alleged Class Period began in January 2025, making this a critical expansion for investors who purchased shares in late 2024. Prominent shareholders rights firm Hagens Berman has been investigating the alleged claims. Read more about the issue facing ATYR investors, The Stakes of Clinical Trials: Why Pharma Companies Must Be Accurate and How it Relates to the aTyr Investigation. The firm urges investors in aTyr who suffered significant losses to submit your losses now. The firm also encourages persons with knowledge who may be able to assist in the investigation to contact its attorneys. Expanded Class Period: November 7, 2024 – September 12, 2025. Lead Plaintiff Deadline: December 8, 2025.Recent Insider Transactions • Oct 12Independent Director recently bought US$912k worth of stockOn the 9th of October, Paul Schimmel bought around 1m shares on-market at roughly US$0.91 per share. This transaction amounted to 91% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$927k more in shares than they have sold in the last 12 months.お知らせ • Oct 11Shamis & Gentile, P.A. Files Securities Class Action Lawsuit Against aTyr Pharma, IncThe law firm of Shamis & Gentile, P.A. alerts investors that a securities class action lawsuit has been filed against aTyr Pharma, Inc. on behalf of investors who purchased or otherwise acquired aTyr Pharma common stock between January 16, 2025 and September 12, 2025, inclusive. The lead plaintiff deadline for this action is December 8, 2025.お知らせ • Sep 30aTyr Pharma, Inc. Presents Additional Findings from Phase 3 EFZO-FIT™? Study in Late-Breaking Oral Abstract at the European Respiratory Society (ERS) Congress 2025aTyr Pharma, Inc. presented additional findings from the Phase 3 EFZO-FIT™? study of efzofitimod in 268 patients with pulmonary sarcoidosis, a major form of interstitial lung disease, in a late-breaking oral abstract presentation by Daniel Culver, D.O., Chair of the Department of Pulmonary Medicine at the Cleveland Clinic and principal investigator of the study, at the European Respiratory Society (ERS) Congress 2025 in Amsterdam, Netherlands. Crucially, the improvements observed for the KSQ-Lung, FAS and KSQ-General Health scores were achieved rapidly and sustained robustly throughout the study. Treatment with efzofitimOD was also associated with a trend toward a greater proportion of patients achieving steroid-free status for at least six months. As previously reported in the topline results, the study did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid dose at week 48. However, clinical benefit for 5.0 mg/kg efzofitimods was observed across multiple study efficacy parameters at week 48 compared to placebo, including complete steroid withdrawal and KSQ-Lung score improvement (p=0.0196), improvement in KSQ-Lung score change from baseline (p=0.0479), preservation of forced vital capacity and a well-tolerated safety profile. Since the primary endpoint was not met, all subsequent statistical testing is reported as nominal findings. Details of the ERS presentation are as follows: EFZO-FIT: The Largest Ever Interventional Trial in Pulmonary Sarcoidosis.Major Estimate Revision • Sep 16Consensus revenue estimates fall by 86%The consensus outlook for revenues in fiscal year 2025 has deteriorated. 2025 revenue forecast decreased from US$6.55m to US$910.0k. Forecast losses increased from -US$0.667 to -US$0.725 per share. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target down from US$20.15 to US$5.06. Share price fell 80% to US$1.08 over the past week.Price Target Changed • Sep 15Price target decreased by 21% to US$15.25Down from US$19.35, the current price target is an average from 7 analysts. New target price is 1,402% above last closing price of US$1.02. Stock is down 47% over the past year. The company is forecast to post a net loss per share of US$0.73 next year compared to a net loss per share of US$0.86 last year.New Risk • Sep 15New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$67m Forecast net loss in 3 years: US$5.1m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$5.1m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (29% increase in shares outstanding).お知らせ • Sep 15Atyr Pharma Announces Topline Results from Phase 3 Efzo-Fit™? Study of Efzofitimod in Pulmonary SarcoidosisaTyr Pharma, Inc. announced topline results from the Phase 3 EFZO-FIT™? study of efzofitimod in 268 patients with pulmonary sarcoidosis, a major form of interstitial lung disease. Based on these findings, which company believe indicate drug activity for efzofitIMod as evidenced by improvements across multiple clinically relevant efficacy endpoints, the Company plans to engage with the U.S. Food and Drug Administration (FDA) to review the results and determine the path forward for efzofitimOD in pulmonary sarcoidosis.Price Target Changed • Aug 22Price target increased by 8.6% to US$20.15Up from US$18.55, the current price target is an average from 10 analysts. New target price is 277% above last closing price of US$5.35. Stock is up 183% over the past year. The company is forecast to post a net loss per share of US$0.67 next year compared to a net loss per share of US$0.86 last year.New Risk • Aug 10New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 42% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$56m free cash flow). Shareholders have been substantially diluted in the past year (42% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Share price has been volatile over the past 3 months (14% average weekly change).Breakeven Date Change • Aug 08The 9 analysts covering aTyr Pharma previously expected the company to break even in 2027. New consensus forecast suggests losses will reduce by 1.6% per year to 2026. The company is expected to make a profit of US$14.0m in 2027. Average annual earnings growth of 76% is required to achieve expected profit on schedule.Price Target Changed • Jul 28Price target increased by 9.3% to US$20.28Up from US$18.55, the current price target is an average from 9 analysts. New target price is 229% above last closing price of US$6.16. Stock is up 191% over the past year. The company is forecast to post a net loss per share of US$0.60 next year compared to a net loss per share of US$0.86 last year.New Risk • Jul 23New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$62m free cash flow). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (29% increase in shares outstanding).お知らせ • Jul 22aTyr Pharma, Inc. Announces Last Patient Visit in Phase 3 EFZO-FIT Study of Efzofitimod in Patients with Pulmonary SarcoidosisaTyr Pharma, Inc. announced that the last patient has completed their last visit in the Company's Phase 3 EFZO-FIT study of its lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis, a major form of interstitial lung disease. The Company expects to report topline results from this study in the third quarter of 2025.New Risk • Jul 01New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$62m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$62m free cash flow). Revenue is less than US$1m. Minor Risk Shareholders have been diluted in the past year (29% increase in shares outstanding).Major Estimate Revision • Jun 06Consensus revenue estimates increase by 227%The consensus outlook for revenues in fiscal year 2025 has improved. 2025 revenue forecast increased from US$2.00m to US$6.55m. Forecast losses expected to reduce from -US$0.661 to -US$0.612 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$18.55 unchanged from last update. Share price rose 20% to US$5.38 over the past week.お知らせ • Jun 04aTyr Pharma, Inc. Announces Findings from Interim Analysis of Ongoing Phase 2 EFZO-Connect™? Study of Efzofitimod in Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD)aTyr Pharma, Inc. announced findings from an interim analysis of eight patients in the ongoing Phase 2 EFZO-CONNECT™? study evaluating its lead therapeutic candidate, efzofitimod, in patients with limited or diffuse systemic sclerosis (SSc, or scleroderma)-related interstitial lung disease (ILD). Key findings to date for efzofitIMod include: Stable or improved mRSS for all patients and an improvement of 4 points or greater for three out of four efzofitimOD-treated patients with diffuse SSc-ILD, where the minimal clinically important difference (MCID) is a 4 to 6 point improvement at 12 months; Preliminary signals of improvement for inflammatory biomarkers including interferon gamma (IFN-g) and monocyte chemoattractant protein-1 (MCP-1) and disease biomarkers Krebs von den Lungen-6 (KL-6) and surfactant protein-D (SP-D). Generally safe and well tolerated at all doses, with no treatment related serious adverse events. EFZO-CONNECT is a Phase 2 randomized, double-blind, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety and tolerability of efzofitimomod in patients with limited or diffuse SSc-ILD. This is a 28-week study with three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzof itimod or placebo dosed intravenously monthly for a total of 6 doses. The study intends to enroll up to 25 patients at multiple centers in the United States. Patients who complete the study are eligible to participate in a 24-week open-label extension. The primary objective of the study is to evaluate the efficacy of multiple doses of intravenous efzofitimods on pulmonary, cutaneous and systemic manifestations in patients with SSc-ILD. Secondary objectives include safety and tolerability. Efzofitimod has been granted U.S. Food and Drug Administration (FDA) and European Union orphan drug and U.S. FDA Fast Track designations for SSc.お知らせ • May 15aTyr Pharma, Inc Advances ATYR0101 to IND Candidate Stage for Pulmonary FibrosisaTyr Pharma, Inc. announced that it has advanced its next investigational new drug (IND) candidate, ATYR0101, which has been selected to be showcased in an oral presentation at the American Thoracic Society (ATS) 2025 Respiratory Innovation Summit, which is scheduled to take place May 16 - 17, 2025, in San Francisco, CA. The presentation will feature preclinical data generated to date for ATYR0101, a fusion protein derived from a proprietary extracellular domain of aspartyl-tRNA synthetase (DARS) that binds to latent transforming growth factor beta binding protein 1 (LTBP-1) to induce cell death of myofibroblasts, which are key cells responsible for driving the progression of fibrosis.分析記事 • Mar 27Will aTyr Pharma (NASDAQ:ATYR) Spend Its Cash Wisely?There's no doubt that money can be made by owning shares of unprofitable businesses. For example, biotech and mining...お知らせ • Mar 26aTyr Pharma, Inc. Announces the Appointment of Dalia R. Rayes as Head of Commercial, Global Efzofitimod FranchiseaTyr Pharma, Inc. announced the appointment of Dalia R. Rayes as Head of Commercial, Global Efzofitimod Franchise. Ms. Rayes brings over 25 years of experience building and leading commercial organizations at biotechnology and pharmaceutical companies, including leading rare disease product launches. She will serve as a member of the Company’s executive leadership team, overseeing global commercial strategy and operations for the efzofitimod program in interstitial lung disease (ILD), including its lead indication in pulmonary sarcoidosis. Ms. Rayes most recently served as Senior Vice President, Head of Commercial for ChemoCentryx, Inc., where she developed and implemented the commercial strategy for the launch of their first product TAVNEOS® ahead of their subsequent acquisition by Amgen. Previously, she spent more than a decade working for Actelion Pharmaceuticals Ltd., where she held key commercial leadership roles across several franchises ahead of their acquisition by Johnson & Johnson. As Senior Director, Business Unit Lead, she launched and scaled the rare disease franchise for VALCHLOR®, and earlier helped lead the blockbuster U.S. launch of OPSUMIT® within the pulmonary arterial hypertension (PAH) portfolio. She began her career at Algorithm Pharmaceuticals, overseeing product launches across 13 countries in the Middle East and North Africa. Ms. Rayes holds a Bachelor of Science in Pharmacy from Beirut Arab University and an MBA from Lebanese American University.New Risk • Mar 25New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 31% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (31% increase in shares outstanding). Revenue is less than US$1m (US$235k revenue). Minor Risk Share price has been volatile over the past 3 months (13% average weekly change).お知らせ • Mar 21aTyr Pharma, Inc., Annual General Meeting, May 01, 2025aTyr Pharma, Inc., Annual General Meeting, May 01, 2025. Location: 10240 sorrento, valley road, ca 92121, san diego United StatesMajor Estimate Revision • Mar 20Consensus EPS estimates upgraded to US$0.69 lossThe consensus outlook for fiscal year 2025 has been updated. 2025 losses forecast to reduce from -US$0.846 to -US$0.689 per share. Revenue forecast unchanged from US$2.00m at last update. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$18.55 unchanged from last update. Share price rose 8.2% to US$3.84 over the past week.Reported Earnings • Mar 14Full year 2024 earnings: EPS and revenues exceed analyst expectationsFull year 2024 results: US$0.86 loss per share. Net loss: US$64.0m (loss widened 27% from FY 2023). Revenue exceeded analyst estimates by 42%. Earnings per share (EPS) also surpassed analyst estimates by 5.6%. Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US.お知らせ • Mar 07aTyr Pharma, Inc. Announces Fourth Positive DSMB Review for Efzofitimod in Phase 3 EFZO-FIT™? Study in Pulmonary SarcoidosisaTyr Pharma, Inc. announced the outcome of a fourth, pre-planned interim safety analysis conducted by an independent data and safety monitoring board (DSMB) for the ongoing Phase 3 EFZO-FIT™? study of the Company's lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis. TheDSMB recommended that the study continue without any modifications. The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction. Secondary endpoints include measures of lung function and sarcoidosis symptoms.お知らせ • Mar 04aTyr Pharma, Inc. to Report Q4, 2024 Results on Mar 13, 2025aTyr Pharma, Inc. announced that they will report Q4, 2024 results After-Market on Mar 13, 2025New Risk • Feb 25New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$67m free cash flow). Shareholders have been substantially diluted in the past year (43% increase in shares outstanding). Revenue is less than US$1m (US$235k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$11m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change).New Risk • Feb 18New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$64m Forecast net loss in 3 years: US$34k This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$67m free cash flow). Shareholders have been substantially diluted in the past year (43% increase in shares outstanding). Revenue is less than US$1m (US$235k revenue). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$34k net loss in 3 years).Price Target Changed • Feb 11Price target decreased by 12% to US$20.00Down from US$22.60, the current price target is an average from 8 analysts. New target price is 439% above last closing price of US$3.71. Stock is up 94% over the past year. The company is forecast to post a net loss per share of US$0.91 next year compared to a net loss per share of US$0.94 last year.New Risk • Jan 15New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 43% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$67m free cash flow). Shareholders have been substantially diluted in the past year (43% increase in shares outstanding). Revenue is less than US$1m (US$235k revenue).Breakeven Date Change • Dec 31Forecast to breakeven in 2027The 7 analysts covering aTyr Pharma expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$29.5m in 2027. Average annual earnings growth of 60% is required to achieve expected profit on schedule.お知らせ • Dec 13aTyr Pharma, Inc. Appoints Eric Benevich to Its Board of DirectorsaTyr Pharma, Inc. announced the appointment of Eric Benevich to the Company’s Board of Directors, effective as of December 10, 2024. Mr. Benevich currently serves as Chief Commercial Officer at Neurocrine Biosciences, Inc. (Neurocrine). Mr. Benevich has served as Chief Commercial Officer of Neurocrine since May 2015 and is responsible for all aspects of commercial development, marketing, and sales of the Neurocrine product portfolio. Mr. Benevich has over 30 years of commercial experience in the pharmaceutical industry and previously served in various positions of increasing responsibility at AstraZeneca, Amgen, Peninsula Pharmaceuticals, and Avanir Pharmaceuticals in the sales and marketing of drugs such as Prilosec®, Epogen®, Enbrel, and Neudexta®. Mr. Benevich has a BBA in International Business from Washington State University.お知らせ • Dec 10aTyr Pharma, Inc. Announces Third Positive DSMB Review for Efzofitimod in Phase 3 EFZO-FIT™ Study in Pulmonary SarcoidosisaTyr Pharma, Inc. announced the outcome of a third, pre-planned interim safety analysis conducted by an independent data and safety monitoring board (DSMB) for the ongoing Phase 3 EFZO-FIT™ study of the Company's lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis. TheDSMB recommended that the study continue without any modifications. The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction. Secondary endpoints include measures of lung function and sarcoidosis symptoms. Efzofitimod is a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. EfzofitIMod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. aTyr is currently investigating efzofitimOD in the global Phase 3 EFZO- FIT™ study in patients with pulmonary sarcoIDosis, a major form of ILD, and in the Phase 2 EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.New Risk • Dec 03New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$67m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$67m free cash flow). Revenue is less than US$1m (US$235k revenue). Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (43% increase in shares outstanding).New Risk • Nov 10New minor risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow. Free cash flow: -US$67m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$235k revenue). Minor Risks Less than 1 year of cash runway based on current free cash flow (-US$67m). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (29% increase in shares outstanding).New Risk • Nov 08New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$58m Forecast net loss in 3 years: US$13m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$588k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$13m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (33% increase in shares outstanding).Seeking Alpha • Sep 09aTyr Pharma: Two 2025 Data Readouts Could Provide Inflection PointSummary Topline data from phase 3 EFZO-FIT study, using efzofitimod for the treatment of patients with pulmonary sarcoidosis, expected Q3 of 2025. The 7 major pulmonary sarcoidosis markets are expected to reach a value of $53.3 billion by 2034. Topline data from the phase 2 EFZO-CONNECT study, using efzofitimod for the treatment of patients with scleroderma-related ILD, expected Q2 of 2025. Several other competitors are creating their own drugs for pulmonary sarcoidosis, such as Novartis with CMK-389, Relief Therapeutics with RL-100, and Kinevant Sciences with Namilumab. Read the full article on Seeking AlphaNew Risk • Jul 26New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$588k revenue). Minor Risks Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding).Recent Insider Transactions • Jul 25Independent Director recently bought US$185k worth of stockOn the 24th of July, Paul Schimmel bought around 100k shares on-market at roughly US$1.85 per share. This transaction amounted to 10.0% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$391k more in shares than they have sold in the last 12 months.お知らせ • Jul 22aTyr Pharma, Inc. Completes Enrollment in Global Pivotal Phase 3 EFZO-FIT™ Study of Efzofitimod in Pulmonary SarcoidosisaTyr Pharma, Inc. announced that it has completed enrollment in its global pivotal Phase 3 EFZO-FIT™ study of its lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis, a major form of interstitial lung disease with limited treatment options. The study enrolled 268 patients at 85 centers in 9 countries, exceeding target enrollment. Topline data from the study are expected in the third quarter of 2025. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. Efzofitimod has received orphan drug designation in the U.S., E.U. and Japan for sarcoidosis and Fast Track designation in the U.S. for pulmonary sarcoidosis.分析記事 • Jul 13We Think aTyr Pharma (NASDAQ:ATYR) Needs To Drive Business Growth CarefullyWe can readily understand why investors are attracted to unprofitable companies. For example, although Amazon.com made...Recent Insider Transactions • Jun 04Independent Chairman of the Board recently bought US$88k worth of stockOn the 30th of May, Timothy Coughlin bought around 50k shares on-market at roughly US$1.75 per share. This transaction increased Timothy's direct individual holding by 8x at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Timothy's only on-market trade for the last 12 months.Price Target Changed • May 30Price target increased by 8.8% to US$24.60Up from US$22.60, the current price target is an average from 5 analysts. New target price is 1,298% above last closing price of US$1.76. Stock is down 22% over the past year. The company is forecast to post a net loss per share of US$0.93 next year compared to a net loss per share of US$0.94 last year.お知らせ • May 15aTyr Pharma, Inc. Announces Second Positive DSMB Review for Efzofitimod in Phase 3 EFZO-FIT™ Study in Pulmonary SarcoidosisaTyr Pharma, Inc. announced that an independent data and safety monitoring board (DSMB) recommended that the ongoing Phase 3 EFZO-FIT™ study of its lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis could continue without any modifications after a second pre-planned, interim analysis. EFZO-FIT™ is a global Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously once a month for a total of 12 doses. The study intends to enroll up to 264 subjects with pulmonary sarcoidosis at multiple centers in the United States, Europe, Japan and Brazil. The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction. Secondary endpoints include measures of lung function and sarcoidosis symptoms.Major Estimate Revision • May 09Consensus revenue estimates decrease by 85%, EPS upgradedThe consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$2.16m to US$320.0k. EPS estimate increased from -US$0.992 to -US$0.917 per share. Biotechs industry in the US expected to see average net income decline 10% next year. Consensus price target of US$22.60 unchanged from last update. Share price rose 7.5% to US$1.72 over the past week.お知らせ • Apr 06aTyr Pharma, Inc., Annual General Meeting, May 22, 2024aTyr Pharma, Inc., Annual General Meeting, May 22, 2024, at 09:00 Pacific Standard Time. Location: 10240 Sorrento Valley Road, San Diego California United States Agenda: To elect two Class III directors, as nominated by the Company’s Board of Directors (the “Board of Directors”), to hold office until the 2027 annual meeting of stockholders or until their successors are duly elected and qualified; to ratify the appointment of Ernst & Young LLP as the independent registered public accounting firm of the Company for its fiscal year ending December 31, 2024; to approve, on an advisory basis, the compensation of the Company’s named executive officers; to approve an amendment to the aTyr Pharma, Inc. 2015 Stock Option and Incentive Plan, as amended; to approve the authorization to adjourn the Annual Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal 4; and to consider other matters.Major Estimate Revision • Mar 21Consensus revenue estimates fall by 70%The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$8.85m to US$2.63m. Forecast losses increased from -US$0.88 to -US$0.992 per share. Biotechs industry in the US expected to see average net income decline 8.2% next year. Consensus price target down from US$26.00 to US$25.25. Share price rose 24% to US$2.02 over the past week.New Risk • Mar 16New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$50m Forecast net loss in 3 years: US$4.9m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$353k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$4.9m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding).New Risk • Mar 15New major risk - Revenue sizeThe company makes less than US$1m in revenue. Total revenue: US$353k This is considered a major risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$353k revenue). Minor Risks Shareholders have been diluted in the past year (10% increase in shares outstanding). Market cap is less than US$100m (US$94.9m market cap).Breakeven Date Change • Mar 15Forecast to breakeven in 2026The 4 analysts covering aTyr Pharma expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$61.9m in 2026. Average annual earnings growth of 61% is required to achieve expected profit on schedule.お知らせ • Feb 29aTyr Pharma, Inc. to Report Q4, 2023 Results on Mar 14, 2024aTyr Pharma, Inc. announced that they will report Q4, 2023 results After-Market on Mar 14, 2024お知らせ • Feb 21aTyr Pharma, Inc. Announces Plans to Initiate an Individual Patient Expanded Access Program for Its Lead Therapeutic Candidate, Efzofitimod, for Patients with Pulmonary SarcoidosisaTyr Pharma, Inc. announced plans to initiate an Individual Patient Expanded Access Program (EAP) for its lead therapeutic candidate, efzofitimod, for patients with pulmonary sarcoidosis. The Individual Patient EAP is intended to allow access for patients who complete the Phase 3 EFZO-FIT™? study and wish to receive treatment with efzofitimOD outside of the clinical trial. EAPs are designed to provide access to potential therapies before they are approved by the U.S. Food and Drug Administration (FDA). sometimes called "compassionate use," Expanded Access is a pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic or medical device) for treatment outside of clinical trials when no satisfactory alternative therapy options are available. By implementing the EAP, the Company does not anticipate any risk to its efzofitimomod drug supply, which it believes to be adequate for its two ongoing clinical trials, or expect a significant impact to its financial resources. The administration of efzofitIMod as part of the Individual Patient EAP will occur independent of the EFZO-FITtm study protocol, and the Company, PIs and patients will remain blinded to the treatment that occurred as part of the EFZO- FIT™? study. Secondary endpoints include measures of lung function and sarcoidosis symptoms.分析記事 • Feb 03We're Hopeful That aTyr Pharma (NASDAQ:LIFE) Will Use Its Cash WiselyThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, although...Major Estimate Revision • Nov 16Consensus revenue estimates fall by 93%The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$5.90m to US$410.0k. Forecast losses increased from -US$0.895 to -US$0.937 per share. Biotechs industry in the US expected to see average net income growth of 5.7% next year. Consensus price target of US$26.00 unchanged from last update. Share price fell 2.6% to US$1.12 over the past week.お知らせ • Nov 01Atyr Pharma, Inc. Announces Dosing of First Patient in Phase 2 Efzo-Connect™? Study of Efzofitimod in Patients with Ssc-IldaTyr Pharma, Inc. announced that it has dosed the first patient in its Phase 2 EFZO-CONNECT™? study. The proof-of-concept study will evaluate the efficacy, safety and tolerability of the Company's lead therapeutic candidate, efzofitimod, compared to placebo in patients with systemic sclerosis (SSc, or scleroderma)-related interstitial lung disease (ILD). Efzofitimod is a first-in-class biologic immunomodulator that selectively modulates activated myeloid cells through neuropilin-2 (NRP2) to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. EfzofitimOD has been granted U.S. Food and Drug Administration (FDA) and European Union orphan drug and U.S. FDA Fast Track designations for SSc. The study intends to enroll 25 patients at multiple centers in the United States. The primary objective of the study is to evaluate the efficacy of multiple doses of intravenous efzofitimOD on pulmonary, cutaneous and systemic manifestations in patients with SSc-ILD. Secondary objectives include safety and tolerability.分析記事 • Oct 04Here's Why We're Not Too Worried About aTyr Pharma's (NASDAQ:LIFE) Cash Burn SituationJust because a business does not make any money, does not mean that the stock will go down. For example, biotech and...お知らせ • Sep 12Atyr Pharma Presents Efzofitimod Data Demonstrating Statistically Significant Improvements in Time to Relapse, Fvc and Patient Reported OutcomesaTyr Pharma, Inc. announced the results of a post-hoc analysis of data from its Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis. The analysis was presented in a poster at the European Respiratory Society (ERS) International Congress 2023, which is taking place September 9 – 13, 2023, in Milan, Italy. The poster is available on the Company’s website. The poster presents findings from a pooled, post-hoc analysis of data from a Phase 1b/2a randomized, double-blind, placebo-controlled, multiple ascending dose (1.0, 3.0 and 5.0 mg/kg) 24-week study of efzofitimod in patients with pulmonary sarcoidosis receiving oral corticosteroid (OCS) dose = 10.0 mg/day. Patients were randomized 1:2 (placebo:efzofitimod) and underwent a forced steroid taper in the first 8 weeks of the study. Dose dependent improvements in steroid burden, FVC and patient reported outcomes (PRO) were noted, though the study was not powered for efficacy. In this pooled analysis, the 3.0 mg/kg (N=8) and 5.0 mg/kg (N=9) efzofitimod arms were considered therapeutic, and pooled. The placebo (N=12) and 1.0 mg/kg (N=8) efzofitimod arm, which was considered subtherapeutic, were pooled. Time to relapse for steroid use (defined as dose of OCS increased after OCS taper to 5.0 mg or less of prednisone or equivalent for at least five consecutive days), rate of change for FVC and proportion of patients with changes that are multiples of the minimally clinically important difference (MCID) in PRO (Kings Sarcoidosis Questionnaire-Lung, or KSQ-L) were compared. Additionally, a responder endpoint was proposed (defined as reduction in OCS from baseline without worsening in FVC or PRO) and an analysis was performed. Key findings include: 7.7% of patients in the therapeutic group relapsed for steroid use compared to 54.4% of patients in the placebo/subtherapeutic group (p=0.017); The rate of change for FVC was significantly improved for the therapeutic group compared to the placebo/subtherapeutic group (p=0.035); 52.9% of patients in the therapeutic group showed an increase =12 for KSQ-L (3 times MCID) compared with 15.0% in the placebo/subtherapeutic group (p=0.032); and 64.7% of patients in the therapeutic group achieved response compared to 20.0% in the placebo/subtherapeutic group (p=0.008). aTyr is currently conducting EFZO-FIT™, a global Phase 3 randomized, double-blind, placebo-controlled 52-week study to evaluate the efficacy and safety of 3.0 mg/kg and 5.0 mg/kg of efzofitimod in 264 patients with pulmonary sarcoidosis. The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction. Secondary endpoints include measures of lung function and sarcoidosis symptoms. Efzofitimod is a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. aTyr is currently investigating efzofitimod in the global Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis, a major form of ILD, and in the Phase 2 EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.Major Estimate Revision • Aug 16Consensus EPS estimates upgraded to US$0.90 lossThe consensus outlook for fiscal year 2023 has been updated. 2023 losses forecast to reduce from -US$1.11 to -US$0.895 per share. Revenue forecast unchanged from US$5.90m at last update. Biotechs industry in the US expected to see average net income decline 19% next year. Consensus price target of US$26.00 unchanged from last update. Share price was steady at US$1.96 over the past week.Price Target Changed • Jun 09Price target increased by 17% to US$23.25Up from US$19.83, the current price target is an average from 4 analysts. New target price is 929% above last closing price of US$2.26. Stock is down 23% over the past year. The company is forecast to post a net loss per share of US$1.00 next year compared to a net loss per share of US$1.60 last year.Major Estimate Revision • May 16Consensus EPS estimates upgraded to US$1.03 lossThe consensus outlook for fiscal year 2023 has been updated. 2023 losses forecast to reduce from -US$1.58 to -US$1.03 per share. Revenue forecast unchanged from US$5.08m at last update. Biotechs industry in the US expected to see average net income decline 85% next year. Consensus price target of US$20.50 unchanged from last update. Share price rose 20% to US$2.57 over the past week.Recent Insider Transactions • May 12Independent Director recently bought US$450k worth of stockOn the 10th of May, Paul Schimmel bought around 200k shares on-market at roughly US$2.25 per share. This transaction amounted to 25% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$515k more in shares than they have sold in the last 12 months.分析記事 • May 06Here's Why We're Watching aTyr Pharma's (NASDAQ:LIFE) Cash Burn SituationThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, although Amazon.com...Major Estimate Revision • Apr 11Consensus revenue estimates fall by 25%The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$6.75m to US$5.08m. Forecast losses increased from -US$1.36 to -US$1.58 per share. Biotechs industry in the US expected to see average net income decline 51% next year. Consensus price target up from US$19.83 to US$20.50. Share price fell 5.2% to US$1.99 over the past week.Price Target Changed • Mar 02Price target increased by 8.9% to US$22.00Up from US$20.20, the current price target is an average from 5 analysts. New target price is 938% above last closing price of US$2.12. Stock is down 59% over the past year. The company is forecast to post a net loss per share of US$1.82 next year compared to a net loss per share of US$1.77 last year.Major Estimate Revision • Feb 09Consensus revenue estimates decrease by 25%The consensus outlook for fiscal year 2022 has been updated. 2022 revenue forecast fell from US$500.0k to US$380.0k. EPS estimate unchanged at -US$1.82 per share. Biotechs industry in the US expected to see average net income decline 87% next year. Consensus price target of US$21.20 unchanged from last update. Share price was steady at US$2.20 over the past week.分析記事 • Jan 04We're Keeping An Eye On aTyr Pharma's (NASDAQ:LIFE) Cash Burn RateEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...Major Estimate Revision • Nov 17Consensus forecasts updatedThe consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$1.00m to US$250.0k. EPS estimate increased from -US$1.84 to -US$1.82 per share. Biotechs industry in the US expected to see average net income decline 94% next year. Consensus price target down from US$22.80 to US$21.20. Share price rose 4.8% to US$2.38 over the past week.Price Target Changed • Nov 16Price target decreased to US$21.20Down from US$22.80, the current price target is an average from 5 analysts. New target price is 758% above last closing price of US$2.47. Stock is down 71% over the past year. The company is forecast to post a net loss per share of US$1.82 next year compared to a net loss per share of US$1.77 last year.Board Change • Nov 16Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 6 highly experienced directors. President, CEO & Director Sanjay Shukla was the last director to join the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.Seeking Alpha • Sep 29aTyr Pharma rises on U.S. patent for anti-neuropilin-2 monoclonal antibodiesaTyr Pharma (NASDAQ:LIFE) said on Thursday the U.S. Patent and Trademark Office had issued a patent covering the company's methods for the use of anti-neuropilin-2 (NRP2) antibodies to treat cancer and inflammation. (LIFE) has risen ~6% before the bell. The blocking antibodies that aTyr has developed target distinct domains of NRP2, including those interacting with semaphorins, VEGF and certain chemokines.Major Estimate Revision • Sep 14Consensus revenue estimates fall by 67%The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$3.00m to US$1.00m. Forecast losses increased from -US$1.76 to -US$1.84 per share. Biotechs industry in the US expected to see average net income decline 66% next year. Consensus price target of US$22.80 unchanged from last update. Share price fell 3.9% to US$3.42 over the past week.Seeking Alpha • Sep 13aTyr Pharma stock rises on FDA fast track status for efzofitimod for lung diseaseThe U.S. Food and Drug Administration (FDA) granted fast track designation to aTyr Pharma's (NASDAQ:LIFE) lead drug candidate efzofitimod to treat systemic sclerosis (SSc, also known as scleroderma)-associated, interstitial lung disease (ILD). SSc is a progressive, autoimmune disease characterized by inflammation and scarring of connective tissues in the body. SSc which occurs in the lungs is called SSc-ILD. Clinical proof-of-concept was seen for efzofitimod in a phase 1b/2a trial in patients with pulmonary sarcoidosis, a form of ILD, the company said in a Sept. 13 press release. aTyr noted that it is currently investigating efzofitimod in patients with pulmonary sarcoidosis in a global phase 3 study called EFZO-FIT. The company added that it was the second fast track designation for efzofitimod clinical program and therapy had previously received the FDA's orphan drug designation for SSc LIFE +8.11% to $4.00 premarket Sept. 13Seeking Alpha • Aug 11aTyr Pharma gains with FDA Fast Track status for lead assetThe shares of clinical-stage biotech aTyr Pharma, Inc. (NASDAQ:LIFE) jumped ~7% in the pre-market Thursday after the company announced that the FDA issued Fast Track designation for its lead candidate efzofitimod for immune-mediated disease, pulmonary sarcoidosis. An immunomodulator, efzofitimod, is designed to downregulate humans' innate and adaptive immune responses. The candidate, also known as ATYR1923, is currently undergoing a global pivotal phase 3 study involving patients with pulmonary sarcoidosis. Sarcoidosis is a leading form of interstitial lung disease, and about 200K Americans are estimated to suffer from pulmonary sarcoidosis. The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at severe conditions with unmet medical needs. It facilitates developers to conduct frequent communications with the regulator on plans for clinical studies. If certain criteria are met, such programs will also be able to win the Accelerated Approval, Priority Review, and Rolling Review, allowing the drugs to reach patients sooner.Price Target Changed • May 18Price target decreased to US$17.33Down from US$19.00, the current price target is an average from 6 analysts. New target price is 478% above last closing price of US$3.00. Stock is down 26% over the past year. The company is forecast to post a net loss per share of US$1.74 next year compared to a net loss per share of US$1.77 last year.Major Estimate Revision • May 17Consensus revenue estimates fall by 33%The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$6.22m to US$4.17m. Forecast losses increased from -US$1.35 to -US$1.74 per share. Biotechs industry in the US expected to see average net income decline 52% next year. Consensus price target broadly unchanged at US$18.67. Share price fell 8.0% to US$3.20 over the past week.分析記事 • May 10We Think aTyr Pharma (NASDAQ:LIFE) Needs To Drive Business Growth CarefullyJust because a business does not make any money, does not mean that the stock will go down. For example, although...Board Change • Apr 27Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 6 highly experienced directors. President, CEO & Director Sanjay Shukla was the last director to join the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.Reported Earnings • Mar 15Full year 2021 earnings: EPS and revenues miss analyst expectationsFull year 2021 results: US$1.77 loss per share (up from US$1.77 loss in FY 2020). Net loss: US$33.8m (loss widened 108% from FY 2020). Revenue missed analyst estimates by 100%. Earnings per share (EPS) also missed analyst estimates by 1.3%. Over the last 3 years on average, earnings per share has increased by 79% per year but the company’s share price has fallen by 13% per year, which means it is significantly lagging earnings.Major Estimate Revision • Mar 15Consensus forecasts updatedThe consensus outlook for 2022 has been updated. 2022 losses forecast to reduce from -US$1.69 to -US$1.43 per share. Revenue forecast unchanged from US$5.08m at last update. Biotechs industry in the US expected to see average net income decline 38% next year. Consensus price target broadly unchanged at US$18.83. Share price fell 2.1% to US$4.75 over the past week.分析記事 • Jan 24Is aTyr Pharma (NASDAQ:LIFE) In A Good Position To Deliver On Growth Plans?Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...Seeking Alpha • Dec 28aTyr Pharma: Successful Proof Of Concept In Pulmonary SarcoidosisaTyr's lead candidate ATYR1923 recently came out with strong data in a proof of concept trial. Lead indication has a large market in the US. Company is early stage, but looks highly interesting.Reported Earnings • Nov 12Third quarter 2021 earnings released: US$0.42 loss per share (vs US$0.68 loss in 3Q 2020)Third quarter 2021 results: Net loss: US$7.67m (loss widened 16% from 3Q 2020). Over the last 3 years on average, earnings per share has increased by 80% per year but the company’s share price has only increased by 6% per year, which means it is significantly lagging earnings growth.Seeking Alpha • Sep 24aTyr Stock Is Buoyant On Highly-Promising Lung Disease Data - Wait For Hype To Die Down And BuyaTyr Pharma produced some surprisingly strong results from recent trials of its lead drug candidate ATYR1923, and its share price has skyrocketed. ATYR1923 is indicated for Pulmonary Sarcoidosis - a ~200k patient population - but could address the $2-$3bn wider ILD market. The company's pipeline is based around founder Paul Schimmel, of the Scripps Institute, and is based around the biology of the extracellular activity of histidyl-tRNA synthetase. It is unique and appears to be quite promising - the company has built an intellectual property portfolio covering >300 protein compositions targeting inflammation, fibrosis and oncology. Analysts have set a consensus price target of ~$19 for aTyr stock, and I would concur that the company ought to be valued >$500m. I would avoid buying now at the peak of the hype cycle, but long term I see >50% upside and perhaps substantially more.分析記事 • Sep 23Is aTyr Pharma (NASDAQ:LIFE) In A Good Position To Deliver On Growth Plans?Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...Price Target Changed • Sep 14Price target increased to US$19.25Up from US$16.25, the current price target is an average from 4 analysts. New target price is 114% above last closing price of US$9.00. Stock is up 119% over the past year.Major Estimate Revision • Aug 12Consensus forecasts updatedThe consensus outlook for 2021 has been updated. 2021 revenue forecast increased from US$4.70m to US$5.00m. Forecast EPS reduced from -US$1.84 to -US$2.30 per share. Biotechs industry in the US expected to see average net income decline 21% next year. Consensus price target of US$16.25 unchanged from last update. Share price rose 5.9% to US$4.84 over the past week.分析記事 • May 22Is aTyr Pharma (NASDAQ:LIFE) In A Good Position To Deliver On Growth Plans?Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...Recent Insider Transactions • May 22Independent Director recently bought US$199k worth of stockOn the 18th of May, Paul Schimmel bought around 50k shares on-market at roughly US$3.98 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$273k more in shares than they have sold in the last 12 months.株主還元ATYRUS BiotechsUS 市場7D-5.7%3.1%1.2%1Y-86.9%34.6%28.7%株主還元を見る業界別リターン: ATYR過去 1 年間で34.6 % の収益を上げたUS Biotechs業界を下回りました。リターン対市場: ATYRは、過去 1 年間で28.7 % のリターンを上げたUS市場を下回りました。価格変動Is ATYR's price volatile compared to industry and market?ATYR volatilityATYR Average Weekly Movement22.7%Biotechs Industry Average Movement10.8%Market Average Movement7.2%10% most volatile stocks in US Market16.4%10% least volatile stocks in US Market3.1%安定した株価: ATYRの株価は、 US市場と比較して過去 3 か月間で変動しています。時間の経過による変動: ATYRの weekly volatility ( 23% ) は過去 1 年間安定していますが、依然としてUSの株式の 75% よりも高くなっています。会社概要設立従業員CEO（最高経営責任者ウェブサイト200559Sanjay Shuklaatyrpharma.com臨床段階のバイオテクノロジー企業であるaTyr Pharma, Inc.は、米国において、tRNA合成酵素の生物学を線維症や炎症に対する新たな治療法に変換する製品候補の発見と開発に従事している。同社の主要治療薬候補であるefzofitimodはNRP2の選択的モジュレーターであり、肺サルコイドーシスの治療薬として第3相臨床試験、サルコイドーシスおよび全身性硬化症性間質性肺疾患（ILD）の治療薬として第2相臨床試験、慢性過敏性肺炎（CHP）や結合組織病関連ILDなどその他のILDの治療薬として第2相臨床試験を実施中である。同社は、線維症治療薬として前臨床開発中のアスパルチルtRNA合成酵素ドメイン由来の融合蛋白質ATYR0101と、肝疾患治療薬としてアラニルtRNA合成酵素ドメイン由来の融合蛋白質ATYR0750を開発中である。aTyr社は2005年に設立され、カリフォルニア州サンディエゴに本社を置いている。もっと見るaTyr Pharma, Inc. 基礎のまとめaTyr Pharma の収益と売上を時価総額と比較するとどうか。ATYR 基礎統計学時価総額US$48.05m収益（TTM）-US$70.03m売上高(TTM)US$190.00k252.9xP/Sレシオ-0.7xPER（株価収益率ATYR は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計ATYR 損益計算書（TTM）収益US$190.00k売上原価US$55.72m売上総利益-US$55.53mその他の費用US$14.50m収益-US$70.03m直近の収益報告Mar 31, 2026次回決算日該当なし一株当たり利益（EPS）-0.71グロス・マージン-29,227.37%純利益率-36,857.37%有利子負債／自己資本比率0%ATYR の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/25 07:40終値2026/05/22 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋aTyr Pharma, Inc. 9 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。19 アナリスト機関James BirchenoughBMO Capital Markets Equity ResearchPrakhar AgrawalCantor Fitzgerald & Co.Ilya ZubkovFreedom Broker16 その他のアナリストを表示
お知らせ • May 12aTyr Pharma, Inc. Provides Regulatory And Clinical Update For Efzofitimod In Pulmonary SarcoidosisaTyr Pharma, Inc. had announced the path forward for its lead therapeutic candidate, efzofitimod, in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD), following the receipt of the official meeting minutes from a Type C meeting with the U.S. Food and Drug Administration (FDA). The purpose of the meeting was to review the results of the Phase 3 EFZO-FIT study and determine the next steps for the program in pulmonary sarcoidosis. Based on feedback from the FDA, the Company plans to continue the development of efzofitimod in pulmonary sarcoidosis in a new Phase 3 study in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease utilizing forced vital capacity (FVC) as the primary endpoint of the study and the King’s Sarcoidosis Questionnaire (KSQ)-Lung score as the key secondary endpoint. The Company chose these endpoints based on the FDA’s indication that FVC and KSQ-Lung are direct measures of how patients suffering from pulmonary sarcoidosis function and feel, and the Company concluded FVC to be a more appropriate primary endpoint at this time pending further content validation work for the KSQ-Lung as recommended by the FDA. The Company plans to submit an investigational new drug (IND) application for this study in June 2026. Evidence from EFZO-FIT shows that patients with restrictive lung disease (defined as FVC percent predicted = 80%) experienced a clinically meaningful benefit for FVC when treated with efzofitimod compared to the observed decline in placebo. Furthermore, these more severe patients from EFZO-FIT also experienced positive trends of improvement across multiple patient-reported outcomes, including the KSQ-Lung score. As part of the discussion with the FDA regarding the benefit risk profile for efzofitimod, the Company plans to increase the frequency of dosing of 5.0 mg/kg efzofitimod or placebo from once every four weeks in past trials to once every three weeks in this next trial. Considering the consistent safety profile seen for efzofitimod in trials to date, the Company believes this strategy to increase drug exposure, coupled with additional risk mitigation strategies and safety surveillance, may enhance the effects of efzofitimod without incurring additional safety concerns. The Phase 3 trial is expected to be a global, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with moderate to severe pulmonary sarcoidosis. The 54-week study will consist of two parallel cohorts randomized equally to either 5.0 mg/kg efzofitimod or placebo dosed intravenously once every 3 weeks for a total of 17 doses. The study is intended to enroll up to approximately 372 patients with symptomatic pulmonary sarcoidosis with restrictive lung disease who are receiving a stable dose of = 5.0 mg daily oral corticosteroid (OCS) and/or a background immunosuppressant. All background treatment will remain stable throughout the duration of the study. The primary endpoint of the study will be change from baseline in FVC at week 48 and the key secondary endpoint will be change from baseline in the KSQ-Lung score at week 48. Efzofitimod is a novel biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. Efzofitimod is currently being investigated in the Phase 2 EFZO-CONNECT study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD, and aTyr intends to submit an investigational new drug (IND) application in June 2026 for a global Phase 3 study of efzofitimod in patients with pulmonary sarcoidosis, a major form of ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.
分析記事 • Apr 17Is aTyr Pharma (NASDAQ:ATYR) In A Good Position To Invest In Growth?There's no doubt that money can be made by owning shares of unprofitable businesses. For example, biotech and mining...
お知らせ • Mar 14aTyr Pharma, Inc., Annual General Meeting, May 11, 2026aTyr Pharma, Inc., Annual General Meeting, May 11, 2026. Location: 10240 sorrento valley road, ca 92121, san diego, United States
Breakeven Date Change • Mar 06No longer forecast to breakevenThe 9 analysts covering aTyr Pharma no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$135.0m in 2028. New consensus forecast suggests the company will make a loss of US$64.0m in 2028.
Major Estimate Revision • Feb 05Consensus revenue estimates increase by 21%The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$100.0k to US$120.0k. EPS estimate unchanged at -US$0.816. Biotechs industry in the US expected to see average net income decline 7.2% next year. Consensus price target of US$4.36 unchanged from last update. Share price fell 4.7% to US$0.81 over the past week.
お知らせ • Feb 03aTyr Pharma, Inc. Announces Scheduling of FDA Type C Meeting to Discuss Efzofitimod Program in Pulmonary SarcoidosisaTyr Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's meeting request to discuss its lead therapeutic candidate, efzofitimod, for the treatment of pulmonary sarcoidosis. The Type C meeting is scheduled for mid-April 2026. EFZO-FIT was a Phase 3 study of efzof itimod in 268 patients with symptomatic pulmonary sarcoidosis. While the study did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid dose at week 48, clinical benefit for 5.0 mg/kg efzofitimOD was observed across multiple study efficacy parameters at week 48 compared to placebo, including improvement in change from baseline for the King's Sarcoidosis Questionnaire (KSQ) -Lung score (p=0.0479), Fatigue Assessment Scale score (p=0. 0226), KSQ-General Health score (p=0.0197), and complete steroid withdrawal with KSQ-Lung score improvement (p=0.0196).
お知らせ • May 12aTyr Pharma, Inc. Provides Regulatory And Clinical Update For Efzofitimod In Pulmonary SarcoidosisaTyr Pharma, Inc. had announced the path forward for its lead therapeutic candidate, efzofitimod, in pulmonary sarcoidosis, a major form of interstitial lung disease (ILD), following the receipt of the official meeting minutes from a Type C meeting with the U.S. Food and Drug Administration (FDA). The purpose of the meeting was to review the results of the Phase 3 EFZO-FIT study and determine the next steps for the program in pulmonary sarcoidosis. Based on feedback from the FDA, the Company plans to continue the development of efzofitimod in pulmonary sarcoidosis in a new Phase 3 study in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease utilizing forced vital capacity (FVC) as the primary endpoint of the study and the King’s Sarcoidosis Questionnaire (KSQ)-Lung score as the key secondary endpoint. The Company chose these endpoints based on the FDA’s indication that FVC and KSQ-Lung are direct measures of how patients suffering from pulmonary sarcoidosis function and feel, and the Company concluded FVC to be a more appropriate primary endpoint at this time pending further content validation work for the KSQ-Lung as recommended by the FDA. The Company plans to submit an investigational new drug (IND) application for this study in June 2026. Evidence from EFZO-FIT shows that patients with restrictive lung disease (defined as FVC percent predicted = 80%) experienced a clinically meaningful benefit for FVC when treated with efzofitimod compared to the observed decline in placebo. Furthermore, these more severe patients from EFZO-FIT also experienced positive trends of improvement across multiple patient-reported outcomes, including the KSQ-Lung score. As part of the discussion with the FDA regarding the benefit risk profile for efzofitimod, the Company plans to increase the frequency of dosing of 5.0 mg/kg efzofitimod or placebo from once every four weeks in past trials to once every three weeks in this next trial. Considering the consistent safety profile seen for efzofitimod in trials to date, the Company believes this strategy to increase drug exposure, coupled with additional risk mitigation strategies and safety surveillance, may enhance the effects of efzofitimod without incurring additional safety concerns. The Phase 3 trial is expected to be a global, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with moderate to severe pulmonary sarcoidosis. The 54-week study will consist of two parallel cohorts randomized equally to either 5.0 mg/kg efzofitimod or placebo dosed intravenously once every 3 weeks for a total of 17 doses. The study is intended to enroll up to approximately 372 patients with symptomatic pulmonary sarcoidosis with restrictive lung disease who are receiving a stable dose of = 5.0 mg daily oral corticosteroid (OCS) and/or a background immunosuppressant. All background treatment will remain stable throughout the duration of the study. The primary endpoint of the study will be change from baseline in FVC at week 48 and the key secondary endpoint will be change from baseline in the KSQ-Lung score at week 48. Efzofitimod is a novel biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. Efzofitimod is currently being investigated in the Phase 2 EFZO-CONNECT study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD, and aTyr intends to submit an investigational new drug (IND) application in June 2026 for a global Phase 3 study of efzofitimod in patients with pulmonary sarcoidosis, a major form of ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.
分析記事 • Apr 17Is aTyr Pharma (NASDAQ:ATYR) In A Good Position To Invest In Growth?There's no doubt that money can be made by owning shares of unprofitable businesses. For example, biotech and mining...
お知らせ • Mar 14aTyr Pharma, Inc., Annual General Meeting, May 11, 2026aTyr Pharma, Inc., Annual General Meeting, May 11, 2026. Location: 10240 sorrento valley road, ca 92121, san diego, United States
Breakeven Date Change • Mar 06No longer forecast to breakevenThe 9 analysts covering aTyr Pharma no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$135.0m in 2028. New consensus forecast suggests the company will make a loss of US$64.0m in 2028.
Major Estimate Revision • Feb 05Consensus revenue estimates increase by 21%The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$100.0k to US$120.0k. EPS estimate unchanged at -US$0.816. Biotechs industry in the US expected to see average net income decline 7.2% next year. Consensus price target of US$4.36 unchanged from last update. Share price fell 4.7% to US$0.81 over the past week.
お知らせ • Feb 03aTyr Pharma, Inc. Announces Scheduling of FDA Type C Meeting to Discuss Efzofitimod Program in Pulmonary SarcoidosisaTyr Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's meeting request to discuss its lead therapeutic candidate, efzofitimod, for the treatment of pulmonary sarcoidosis. The Type C meeting is scheduled for mid-April 2026. EFZO-FIT was a Phase 3 study of efzof itimod in 268 patients with symptomatic pulmonary sarcoidosis. While the study did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid dose at week 48, clinical benefit for 5.0 mg/kg efzofitimOD was observed across multiple study efficacy parameters at week 48 compared to placebo, including improvement in change from baseline for the King's Sarcoidosis Questionnaire (KSQ) -Lung score (p=0.0479), Fatigue Assessment Scale score (p=0. 0226), KSQ-General Health score (p=0.0197), and complete steroid withdrawal with KSQ-Lung score improvement (p=0.0196).
分析記事 • Dec 18Is aTyr Pharma (NASDAQ:ATYR) In A Good Position To Invest In Growth?We can readily understand why investors are attracted to unprofitable companies. For example, although Amazon.com made...
お知らせ • Dec 06Atyr Pharma Receives Deficiency Notice for Non-Compliance with Nasdaq Listing RulesOn December 4, 2025, aTyr Pharma, Inc. received a deficiency notice (the “Notice”) from the listing qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that, for the last 30 consecutive business days preceding the date of the Notice, the bid price of the Company’s common stock had closed below $1.00 per share, the minimum closing bid price required by the continued listing requirements of Nasdaq Listing Rule 5550(a)(2). The Notice has no immediate effect on the listing of the Company’s common stock on The Nasdaq Capital Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 calendar days, or until June 2, 2026 (the “Compliance Date”) to regain compliance with the minimum bid price requirement by having shares of the Company’s common stock maintain a minimum closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days before the Compliance Date. If the Company’s common stock does not achieve compliance by the Compliance Date, the Company may be eligible for an additional 180-day period to regain compliance. To qualify for the second compliance period, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice to Nasdaq of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. However, if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible for the second compliance period, and the Company does not regain compliance by the Compliance Date, the Staff will provide written notification that the Company’s common stock is subject to delisting. At that time, the Company may appeal the delisting determination to a hearings panel pursuant to the procedures set forth in the applicable Nasdaq listing rules. However, there can be no assurance that, if the Company receives a delisting notice and appeals the delisting determination by Nasdaq to the panel, such appeal would be successful. The Company intends to actively monitor the closing bid price of its common stock between now and the Compliance Date and, as appropriate, will evaluate available options to resolve the deficiency and regain compliance with the minimum bid price requirement.
Price Target Changed • Nov 14Price target increased by 8.9% to US$4.36Up from US$4.00, the current price target is an average from 7 analysts. New target price is 511% above last closing price of US$0.71. Stock is down 78% over the past year. The company is forecast to post a net loss per share of US$0.82 next year compared to a net loss per share of US$0.86 last year.
お知らせ • Nov 12A New aTyr Pharma, Inc. Securities Class Filed; Class Period Significantly EnlargedA new class action complaint has been filed against aTyr Pharma, Inc. and certain of its top executives, significantly enlarging the alleged class period covered by the ongoing securities litigation. The new class action, Kingv. aTyr Pharma Inc., filed in the U.S. District Court for the Southern District of California on behalf of investors who suffered substantial losses, now seeks to represent all persons and entities who acquired aTyr Pharma securities between November 7, 2024, and September 12, 2025, inclusive. The previous alleged Class Period began in January 2025, making this a critical expansion for investors who purchased shares in late 2024. Prominent shareholders rights firm Hagens Berman has been investigating the alleged claims. Read more about the issue facing ATYR investors, The Stakes of Clinical Trials: Why Pharma Companies Must Be Accurate and How it Relates to the aTyr Investigation. The firm urges investors in aTyr who suffered significant losses to submit your losses now. The firm also encourages persons with knowledge who may be able to assist in the investigation to contact its attorneys. Expanded Class Period: November 7, 2024 – September 12, 2025. Lead Plaintiff Deadline: December 8, 2025.
Recent Insider Transactions • Oct 12Independent Director recently bought US$912k worth of stockOn the 9th of October, Paul Schimmel bought around 1m shares on-market at roughly US$0.91 per share. This transaction amounted to 91% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$927k more in shares than they have sold in the last 12 months.
お知らせ • Oct 11Shamis & Gentile, P.A. Files Securities Class Action Lawsuit Against aTyr Pharma, IncThe law firm of Shamis & Gentile, P.A. alerts investors that a securities class action lawsuit has been filed against aTyr Pharma, Inc. on behalf of investors who purchased or otherwise acquired aTyr Pharma common stock between January 16, 2025 and September 12, 2025, inclusive. The lead plaintiff deadline for this action is December 8, 2025.
お知らせ • Sep 30aTyr Pharma, Inc. Presents Additional Findings from Phase 3 EFZO-FIT™? Study in Late-Breaking Oral Abstract at the European Respiratory Society (ERS) Congress 2025aTyr Pharma, Inc. presented additional findings from the Phase 3 EFZO-FIT™? study of efzofitimod in 268 patients with pulmonary sarcoidosis, a major form of interstitial lung disease, in a late-breaking oral abstract presentation by Daniel Culver, D.O., Chair of the Department of Pulmonary Medicine at the Cleveland Clinic and principal investigator of the study, at the European Respiratory Society (ERS) Congress 2025 in Amsterdam, Netherlands. Crucially, the improvements observed for the KSQ-Lung, FAS and KSQ-General Health scores were achieved rapidly and sustained robustly throughout the study. Treatment with efzofitimOD was also associated with a trend toward a greater proportion of patients achieving steroid-free status for at least six months. As previously reported in the topline results, the study did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid dose at week 48. However, clinical benefit for 5.0 mg/kg efzofitimods was observed across multiple study efficacy parameters at week 48 compared to placebo, including complete steroid withdrawal and KSQ-Lung score improvement (p=0.0196), improvement in KSQ-Lung score change from baseline (p=0.0479), preservation of forced vital capacity and a well-tolerated safety profile. Since the primary endpoint was not met, all subsequent statistical testing is reported as nominal findings. Details of the ERS presentation are as follows: EFZO-FIT: The Largest Ever Interventional Trial in Pulmonary Sarcoidosis.
Major Estimate Revision • Sep 16Consensus revenue estimates fall by 86%The consensus outlook for revenues in fiscal year 2025 has deteriorated. 2025 revenue forecast decreased from US$6.55m to US$910.0k. Forecast losses increased from -US$0.667 to -US$0.725 per share. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target down from US$20.15 to US$5.06. Share price fell 80% to US$1.08 over the past week.
Price Target Changed • Sep 15Price target decreased by 21% to US$15.25Down from US$19.35, the current price target is an average from 7 analysts. New target price is 1,402% above last closing price of US$1.02. Stock is down 47% over the past year. The company is forecast to post a net loss per share of US$0.73 next year compared to a net loss per share of US$0.86 last year.
New Risk • Sep 15New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$67m Forecast net loss in 3 years: US$5.1m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$5.1m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (29% increase in shares outstanding).
お知らせ • Sep 15Atyr Pharma Announces Topline Results from Phase 3 Efzo-Fit™? Study of Efzofitimod in Pulmonary SarcoidosisaTyr Pharma, Inc. announced topline results from the Phase 3 EFZO-FIT™? study of efzofitimod in 268 patients with pulmonary sarcoidosis, a major form of interstitial lung disease. Based on these findings, which company believe indicate drug activity for efzofitIMod as evidenced by improvements across multiple clinically relevant efficacy endpoints, the Company plans to engage with the U.S. Food and Drug Administration (FDA) to review the results and determine the path forward for efzofitimOD in pulmonary sarcoidosis.
Price Target Changed • Aug 22Price target increased by 8.6% to US$20.15Up from US$18.55, the current price target is an average from 10 analysts. New target price is 277% above last closing price of US$5.35. Stock is up 183% over the past year. The company is forecast to post a net loss per share of US$0.67 next year compared to a net loss per share of US$0.86 last year.
New Risk • Aug 10New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 42% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$56m free cash flow). Shareholders have been substantially diluted in the past year (42% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Share price has been volatile over the past 3 months (14% average weekly change).
Breakeven Date Change • Aug 08The 9 analysts covering aTyr Pharma previously expected the company to break even in 2027. New consensus forecast suggests losses will reduce by 1.6% per year to 2026. The company is expected to make a profit of US$14.0m in 2027. Average annual earnings growth of 76% is required to achieve expected profit on schedule.
Price Target Changed • Jul 28Price target increased by 9.3% to US$20.28Up from US$18.55, the current price target is an average from 9 analysts. New target price is 229% above last closing price of US$6.16. Stock is up 191% over the past year. The company is forecast to post a net loss per share of US$0.60 next year compared to a net loss per share of US$0.86 last year.
New Risk • Jul 23New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$62m free cash flow). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (29% increase in shares outstanding).
お知らせ • Jul 22aTyr Pharma, Inc. Announces Last Patient Visit in Phase 3 EFZO-FIT Study of Efzofitimod in Patients with Pulmonary SarcoidosisaTyr Pharma, Inc. announced that the last patient has completed their last visit in the Company's Phase 3 EFZO-FIT study of its lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis, a major form of interstitial lung disease. The Company expects to report topline results from this study in the third quarter of 2025.
New Risk • Jul 01New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$62m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$62m free cash flow). Revenue is less than US$1m. Minor Risk Shareholders have been diluted in the past year (29% increase in shares outstanding).
Major Estimate Revision • Jun 06Consensus revenue estimates increase by 227%The consensus outlook for revenues in fiscal year 2025 has improved. 2025 revenue forecast increased from US$2.00m to US$6.55m. Forecast losses expected to reduce from -US$0.661 to -US$0.612 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$18.55 unchanged from last update. Share price rose 20% to US$5.38 over the past week.
お知らせ • Jun 04aTyr Pharma, Inc. Announces Findings from Interim Analysis of Ongoing Phase 2 EFZO-Connect™? Study of Efzofitimod in Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD)aTyr Pharma, Inc. announced findings from an interim analysis of eight patients in the ongoing Phase 2 EFZO-CONNECT™? study evaluating its lead therapeutic candidate, efzofitimod, in patients with limited or diffuse systemic sclerosis (SSc, or scleroderma)-related interstitial lung disease (ILD). Key findings to date for efzofitIMod include: Stable or improved mRSS for all patients and an improvement of 4 points or greater for three out of four efzofitimOD-treated patients with diffuse SSc-ILD, where the minimal clinically important difference (MCID) is a 4 to 6 point improvement at 12 months; Preliminary signals of improvement for inflammatory biomarkers including interferon gamma (IFN-g) and monocyte chemoattractant protein-1 (MCP-1) and disease biomarkers Krebs von den Lungen-6 (KL-6) and surfactant protein-D (SP-D). Generally safe and well tolerated at all doses, with no treatment related serious adverse events. EFZO-CONNECT is a Phase 2 randomized, double-blind, placebo-controlled, proof-of-concept study to evaluate the efficacy, safety and tolerability of efzofitimomod in patients with limited or diffuse SSc-ILD. This is a 28-week study with three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzof itimod or placebo dosed intravenously monthly for a total of 6 doses. The study intends to enroll up to 25 patients at multiple centers in the United States. Patients who complete the study are eligible to participate in a 24-week open-label extension. The primary objective of the study is to evaluate the efficacy of multiple doses of intravenous efzofitimods on pulmonary, cutaneous and systemic manifestations in patients with SSc-ILD. Secondary objectives include safety and tolerability. Efzofitimod has been granted U.S. Food and Drug Administration (FDA) and European Union orphan drug and U.S. FDA Fast Track designations for SSc.
お知らせ • May 15aTyr Pharma, Inc Advances ATYR0101 to IND Candidate Stage for Pulmonary FibrosisaTyr Pharma, Inc. announced that it has advanced its next investigational new drug (IND) candidate, ATYR0101, which has been selected to be showcased in an oral presentation at the American Thoracic Society (ATS) 2025 Respiratory Innovation Summit, which is scheduled to take place May 16 - 17, 2025, in San Francisco, CA. The presentation will feature preclinical data generated to date for ATYR0101, a fusion protein derived from a proprietary extracellular domain of aspartyl-tRNA synthetase (DARS) that binds to latent transforming growth factor beta binding protein 1 (LTBP-1) to induce cell death of myofibroblasts, which are key cells responsible for driving the progression of fibrosis.
分析記事 • Mar 27Will aTyr Pharma (NASDAQ:ATYR) Spend Its Cash Wisely?There's no doubt that money can be made by owning shares of unprofitable businesses. For example, biotech and mining...
お知らせ • Mar 26aTyr Pharma, Inc. Announces the Appointment of Dalia R. Rayes as Head of Commercial, Global Efzofitimod FranchiseaTyr Pharma, Inc. announced the appointment of Dalia R. Rayes as Head of Commercial, Global Efzofitimod Franchise. Ms. Rayes brings over 25 years of experience building and leading commercial organizations at biotechnology and pharmaceutical companies, including leading rare disease product launches. She will serve as a member of the Company’s executive leadership team, overseeing global commercial strategy and operations for the efzofitimod program in interstitial lung disease (ILD), including its lead indication in pulmonary sarcoidosis. Ms. Rayes most recently served as Senior Vice President, Head of Commercial for ChemoCentryx, Inc., where she developed and implemented the commercial strategy for the launch of their first product TAVNEOS® ahead of their subsequent acquisition by Amgen. Previously, she spent more than a decade working for Actelion Pharmaceuticals Ltd., where she held key commercial leadership roles across several franchises ahead of their acquisition by Johnson & Johnson. As Senior Director, Business Unit Lead, she launched and scaled the rare disease franchise for VALCHLOR®, and earlier helped lead the blockbuster U.S. launch of OPSUMIT® within the pulmonary arterial hypertension (PAH) portfolio. She began her career at Algorithm Pharmaceuticals, overseeing product launches across 13 countries in the Middle East and North Africa. Ms. Rayes holds a Bachelor of Science in Pharmacy from Beirut Arab University and an MBA from Lebanese American University.
New Risk • Mar 25New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 31% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (31% increase in shares outstanding). Revenue is less than US$1m (US$235k revenue). Minor Risk Share price has been volatile over the past 3 months (13% average weekly change).
お知らせ • Mar 21aTyr Pharma, Inc., Annual General Meeting, May 01, 2025aTyr Pharma, Inc., Annual General Meeting, May 01, 2025. Location: 10240 sorrento, valley road, ca 92121, san diego United States
Major Estimate Revision • Mar 20Consensus EPS estimates upgraded to US$0.69 lossThe consensus outlook for fiscal year 2025 has been updated. 2025 losses forecast to reduce from -US$0.846 to -US$0.689 per share. Revenue forecast unchanged from US$2.00m at last update. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$18.55 unchanged from last update. Share price rose 8.2% to US$3.84 over the past week.
Reported Earnings • Mar 14Full year 2024 earnings: EPS and revenues exceed analyst expectationsFull year 2024 results: US$0.86 loss per share. Net loss: US$64.0m (loss widened 27% from FY 2023). Revenue exceeded analyst estimates by 42%. Earnings per share (EPS) also surpassed analyst estimates by 5.6%. Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US.
お知らせ • Mar 07aTyr Pharma, Inc. Announces Fourth Positive DSMB Review for Efzofitimod in Phase 3 EFZO-FIT™? Study in Pulmonary SarcoidosisaTyr Pharma, Inc. announced the outcome of a fourth, pre-planned interim safety analysis conducted by an independent data and safety monitoring board (DSMB) for the ongoing Phase 3 EFZO-FIT™? study of the Company's lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis. TheDSMB recommended that the study continue without any modifications. The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction. Secondary endpoints include measures of lung function and sarcoidosis symptoms.
お知らせ • Mar 04aTyr Pharma, Inc. to Report Q4, 2024 Results on Mar 13, 2025aTyr Pharma, Inc. announced that they will report Q4, 2024 results After-Market on Mar 13, 2025
New Risk • Feb 25New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$67m free cash flow). Shareholders have been substantially diluted in the past year (43% increase in shares outstanding). Revenue is less than US$1m (US$235k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$11m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change).
New Risk • Feb 18New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$64m Forecast net loss in 3 years: US$34k This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$67m free cash flow). Shareholders have been substantially diluted in the past year (43% increase in shares outstanding). Revenue is less than US$1m (US$235k revenue). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$34k net loss in 3 years).
Price Target Changed • Feb 11Price target decreased by 12% to US$20.00Down from US$22.60, the current price target is an average from 8 analysts. New target price is 439% above last closing price of US$3.71. Stock is up 94% over the past year. The company is forecast to post a net loss per share of US$0.91 next year compared to a net loss per share of US$0.94 last year.
New Risk • Jan 15New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 43% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$67m free cash flow). Shareholders have been substantially diluted in the past year (43% increase in shares outstanding). Revenue is less than US$1m (US$235k revenue).
Breakeven Date Change • Dec 31Forecast to breakeven in 2027The 7 analysts covering aTyr Pharma expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$29.5m in 2027. Average annual earnings growth of 60% is required to achieve expected profit on schedule.
お知らせ • Dec 13aTyr Pharma, Inc. Appoints Eric Benevich to Its Board of DirectorsaTyr Pharma, Inc. announced the appointment of Eric Benevich to the Company’s Board of Directors, effective as of December 10, 2024. Mr. Benevich currently serves as Chief Commercial Officer at Neurocrine Biosciences, Inc. (Neurocrine). Mr. Benevich has served as Chief Commercial Officer of Neurocrine since May 2015 and is responsible for all aspects of commercial development, marketing, and sales of the Neurocrine product portfolio. Mr. Benevich has over 30 years of commercial experience in the pharmaceutical industry and previously served in various positions of increasing responsibility at AstraZeneca, Amgen, Peninsula Pharmaceuticals, and Avanir Pharmaceuticals in the sales and marketing of drugs such as Prilosec®, Epogen®, Enbrel, and Neudexta®. Mr. Benevich has a BBA in International Business from Washington State University.
お知らせ • Dec 10aTyr Pharma, Inc. Announces Third Positive DSMB Review for Efzofitimod in Phase 3 EFZO-FIT™ Study in Pulmonary SarcoidosisaTyr Pharma, Inc. announced the outcome of a third, pre-planned interim safety analysis conducted by an independent data and safety monitoring board (DSMB) for the ongoing Phase 3 EFZO-FIT™ study of the Company's lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis. TheDSMB recommended that the study continue without any modifications. The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction. Secondary endpoints include measures of lung function and sarcoidosis symptoms. Efzofitimod is a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. EfzofitIMod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. aTyr is currently investigating efzofitimOD in the global Phase 3 EFZO- FIT™ study in patients with pulmonary sarcoIDosis, a major form of ILD, and in the Phase 2 EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.
New Risk • Dec 03New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$67m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$67m free cash flow). Revenue is less than US$1m (US$235k revenue). Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (43% increase in shares outstanding).
New Risk • Nov 10New minor risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow. Free cash flow: -US$67m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$235k revenue). Minor Risks Less than 1 year of cash runway based on current free cash flow (-US$67m). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (29% increase in shares outstanding).
New Risk • Nov 08New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$58m Forecast net loss in 3 years: US$13m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$588k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$13m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (33% increase in shares outstanding).
Seeking Alpha • Sep 09aTyr Pharma: Two 2025 Data Readouts Could Provide Inflection PointSummary Topline data from phase 3 EFZO-FIT study, using efzofitimod for the treatment of patients with pulmonary sarcoidosis, expected Q3 of 2025. The 7 major pulmonary sarcoidosis markets are expected to reach a value of $53.3 billion by 2034. Topline data from the phase 2 EFZO-CONNECT study, using efzofitimod for the treatment of patients with scleroderma-related ILD, expected Q2 of 2025. Several other competitors are creating their own drugs for pulmonary sarcoidosis, such as Novartis with CMK-389, Relief Therapeutics with RL-100, and Kinevant Sciences with Namilumab. Read the full article on Seeking Alpha
New Risk • Jul 26New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$588k revenue). Minor Risks Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding).
Recent Insider Transactions • Jul 25Independent Director recently bought US$185k worth of stockOn the 24th of July, Paul Schimmel bought around 100k shares on-market at roughly US$1.85 per share. This transaction amounted to 10.0% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$391k more in shares than they have sold in the last 12 months.
お知らせ • Jul 22aTyr Pharma, Inc. Completes Enrollment in Global Pivotal Phase 3 EFZO-FIT™ Study of Efzofitimod in Pulmonary SarcoidosisaTyr Pharma, Inc. announced that it has completed enrollment in its global pivotal Phase 3 EFZO-FIT™ study of its lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis, a major form of interstitial lung disease with limited treatment options. The study enrolled 268 patients at 85 centers in 9 countries, exceeding target enrollment. Topline data from the study are expected in the third quarter of 2025. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. Efzofitimod has received orphan drug designation in the U.S., E.U. and Japan for sarcoidosis and Fast Track designation in the U.S. for pulmonary sarcoidosis.
分析記事 • Jul 13We Think aTyr Pharma (NASDAQ:ATYR) Needs To Drive Business Growth CarefullyWe can readily understand why investors are attracted to unprofitable companies. For example, although Amazon.com made...
Recent Insider Transactions • Jun 04Independent Chairman of the Board recently bought US$88k worth of stockOn the 30th of May, Timothy Coughlin bought around 50k shares on-market at roughly US$1.75 per share. This transaction increased Timothy's direct individual holding by 8x at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Timothy's only on-market trade for the last 12 months.
Price Target Changed • May 30Price target increased by 8.8% to US$24.60Up from US$22.60, the current price target is an average from 5 analysts. New target price is 1,298% above last closing price of US$1.76. Stock is down 22% over the past year. The company is forecast to post a net loss per share of US$0.93 next year compared to a net loss per share of US$0.94 last year.
お知らせ • May 15aTyr Pharma, Inc. Announces Second Positive DSMB Review for Efzofitimod in Phase 3 EFZO-FIT™ Study in Pulmonary SarcoidosisaTyr Pharma, Inc. announced that an independent data and safety monitoring board (DSMB) recommended that the ongoing Phase 3 EFZO-FIT™ study of its lead therapeutic candidate, efzofitimod, in patients with pulmonary sarcoidosis could continue without any modifications after a second pre-planned, interim analysis. EFZO-FIT™ is a global Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis. This is a 52-week study consisting of three parallel cohorts randomized equally to either 3.0 mg/kg or 5.0 mg/kg of efzofitimod or placebo dosed intravenously once a month for a total of 12 doses. The study intends to enroll up to 264 subjects with pulmonary sarcoidosis at multiple centers in the United States, Europe, Japan and Brazil. The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction. Secondary endpoints include measures of lung function and sarcoidosis symptoms.
Major Estimate Revision • May 09Consensus revenue estimates decrease by 85%, EPS upgradedThe consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$2.16m to US$320.0k. EPS estimate increased from -US$0.992 to -US$0.917 per share. Biotechs industry in the US expected to see average net income decline 10% next year. Consensus price target of US$22.60 unchanged from last update. Share price rose 7.5% to US$1.72 over the past week.
お知らせ • Apr 06aTyr Pharma, Inc., Annual General Meeting, May 22, 2024aTyr Pharma, Inc., Annual General Meeting, May 22, 2024, at 09:00 Pacific Standard Time. Location: 10240 Sorrento Valley Road, San Diego California United States Agenda: To elect two Class III directors, as nominated by the Company’s Board of Directors (the “Board of Directors”), to hold office until the 2027 annual meeting of stockholders or until their successors are duly elected and qualified; to ratify the appointment of Ernst & Young LLP as the independent registered public accounting firm of the Company for its fiscal year ending December 31, 2024; to approve, on an advisory basis, the compensation of the Company’s named executive officers; to approve an amendment to the aTyr Pharma, Inc. 2015 Stock Option and Incentive Plan, as amended; to approve the authorization to adjourn the Annual Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of Proposal 4; and to consider other matters.
Major Estimate Revision • Mar 21Consensus revenue estimates fall by 70%The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$8.85m to US$2.63m. Forecast losses increased from -US$0.88 to -US$0.992 per share. Biotechs industry in the US expected to see average net income decline 8.2% next year. Consensus price target down from US$26.00 to US$25.25. Share price rose 24% to US$2.02 over the past week.
New Risk • Mar 16New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$50m Forecast net loss in 3 years: US$4.9m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$353k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$4.9m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding).
New Risk • Mar 15New major risk - Revenue sizeThe company makes less than US$1m in revenue. Total revenue: US$353k This is considered a major risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$353k revenue). Minor Risks Shareholders have been diluted in the past year (10% increase in shares outstanding). Market cap is less than US$100m (US$94.9m market cap).
Breakeven Date Change • Mar 15Forecast to breakeven in 2026The 4 analysts covering aTyr Pharma expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$61.9m in 2026. Average annual earnings growth of 61% is required to achieve expected profit on schedule.
お知らせ • Feb 29aTyr Pharma, Inc. to Report Q4, 2023 Results on Mar 14, 2024aTyr Pharma, Inc. announced that they will report Q4, 2023 results After-Market on Mar 14, 2024
お知らせ • Feb 21aTyr Pharma, Inc. Announces Plans to Initiate an Individual Patient Expanded Access Program for Its Lead Therapeutic Candidate, Efzofitimod, for Patients with Pulmonary SarcoidosisaTyr Pharma, Inc. announced plans to initiate an Individual Patient Expanded Access Program (EAP) for its lead therapeutic candidate, efzofitimod, for patients with pulmonary sarcoidosis. The Individual Patient EAP is intended to allow access for patients who complete the Phase 3 EFZO-FIT™? study and wish to receive treatment with efzofitimOD outside of the clinical trial. EAPs are designed to provide access to potential therapies before they are approved by the U.S. Food and Drug Administration (FDA). sometimes called "compassionate use," Expanded Access is a pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic or medical device) for treatment outside of clinical trials when no satisfactory alternative therapy options are available. By implementing the EAP, the Company does not anticipate any risk to its efzofitimomod drug supply, which it believes to be adequate for its two ongoing clinical trials, or expect a significant impact to its financial resources. The administration of efzofitIMod as part of the Individual Patient EAP will occur independent of the EFZO-FITtm study protocol, and the Company, PIs and patients will remain blinded to the treatment that occurred as part of the EFZO- FIT™? study. Secondary endpoints include measures of lung function and sarcoidosis symptoms.
分析記事 • Feb 03We're Hopeful That aTyr Pharma (NASDAQ:LIFE) Will Use Its Cash WiselyThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, although...
Major Estimate Revision • Nov 16Consensus revenue estimates fall by 93%The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$5.90m to US$410.0k. Forecast losses increased from -US$0.895 to -US$0.937 per share. Biotechs industry in the US expected to see average net income growth of 5.7% next year. Consensus price target of US$26.00 unchanged from last update. Share price fell 2.6% to US$1.12 over the past week.
お知らせ • Nov 01Atyr Pharma, Inc. Announces Dosing of First Patient in Phase 2 Efzo-Connect™? Study of Efzofitimod in Patients with Ssc-IldaTyr Pharma, Inc. announced that it has dosed the first patient in its Phase 2 EFZO-CONNECT™? study. The proof-of-concept study will evaluate the efficacy, safety and tolerability of the Company's lead therapeutic candidate, efzofitimod, compared to placebo in patients with systemic sclerosis (SSc, or scleroderma)-related interstitial lung disease (ILD). Efzofitimod is a first-in-class biologic immunomodulator that selectively modulates activated myeloid cells through neuropilin-2 (NRP2) to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. EfzofitimOD has been granted U.S. Food and Drug Administration (FDA) and European Union orphan drug and U.S. FDA Fast Track designations for SSc. The study intends to enroll 25 patients at multiple centers in the United States. The primary objective of the study is to evaluate the efficacy of multiple doses of intravenous efzofitimOD on pulmonary, cutaneous and systemic manifestations in patients with SSc-ILD. Secondary objectives include safety and tolerability.
分析記事 • Oct 04Here's Why We're Not Too Worried About aTyr Pharma's (NASDAQ:LIFE) Cash Burn SituationJust because a business does not make any money, does not mean that the stock will go down. For example, biotech and...
お知らせ • Sep 12Atyr Pharma Presents Efzofitimod Data Demonstrating Statistically Significant Improvements in Time to Relapse, Fvc and Patient Reported OutcomesaTyr Pharma, Inc. announced the results of a post-hoc analysis of data from its Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis. The analysis was presented in a poster at the European Respiratory Society (ERS) International Congress 2023, which is taking place September 9 – 13, 2023, in Milan, Italy. The poster is available on the Company’s website. The poster presents findings from a pooled, post-hoc analysis of data from a Phase 1b/2a randomized, double-blind, placebo-controlled, multiple ascending dose (1.0, 3.0 and 5.0 mg/kg) 24-week study of efzofitimod in patients with pulmonary sarcoidosis receiving oral corticosteroid (OCS) dose = 10.0 mg/day. Patients were randomized 1:2 (placebo:efzofitimod) and underwent a forced steroid taper in the first 8 weeks of the study. Dose dependent improvements in steroid burden, FVC and patient reported outcomes (PRO) were noted, though the study was not powered for efficacy. In this pooled analysis, the 3.0 mg/kg (N=8) and 5.0 mg/kg (N=9) efzofitimod arms were considered therapeutic, and pooled. The placebo (N=12) and 1.0 mg/kg (N=8) efzofitimod arm, which was considered subtherapeutic, were pooled. Time to relapse for steroid use (defined as dose of OCS increased after OCS taper to 5.0 mg or less of prednisone or equivalent for at least five consecutive days), rate of change for FVC and proportion of patients with changes that are multiples of the minimally clinically important difference (MCID) in PRO (Kings Sarcoidosis Questionnaire-Lung, or KSQ-L) were compared. Additionally, a responder endpoint was proposed (defined as reduction in OCS from baseline without worsening in FVC or PRO) and an analysis was performed. Key findings include: 7.7% of patients in the therapeutic group relapsed for steroid use compared to 54.4% of patients in the placebo/subtherapeutic group (p=0.017); The rate of change for FVC was significantly improved for the therapeutic group compared to the placebo/subtherapeutic group (p=0.035); 52.9% of patients in the therapeutic group showed an increase =12 for KSQ-L (3 times MCID) compared with 15.0% in the placebo/subtherapeutic group (p=0.032); and 64.7% of patients in the therapeutic group achieved response compared to 20.0% in the placebo/subtherapeutic group (p=0.008). aTyr is currently conducting EFZO-FIT™, a global Phase 3 randomized, double-blind, placebo-controlled 52-week study to evaluate the efficacy and safety of 3.0 mg/kg and 5.0 mg/kg of efzofitimod in 264 patients with pulmonary sarcoidosis. The trial design incorporates a forced steroid taper. The primary endpoint of the study is steroid reduction. Secondary endpoints include measures of lung function and sarcoidosis symptoms. Efzofitimod is a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis. aTyr is currently investigating efzofitimod in the global Phase 3 EFZO-FIT™ study in patients with pulmonary sarcoidosis, a major form of ILD, and in the Phase 2 EFZO-CONNECT™ study in patients with systemic sclerosis (SSc, or scleroderma)-related ILD. These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.
Major Estimate Revision • Aug 16Consensus EPS estimates upgraded to US$0.90 lossThe consensus outlook for fiscal year 2023 has been updated. 2023 losses forecast to reduce from -US$1.11 to -US$0.895 per share. Revenue forecast unchanged from US$5.90m at last update. Biotechs industry in the US expected to see average net income decline 19% next year. Consensus price target of US$26.00 unchanged from last update. Share price was steady at US$1.96 over the past week.
Price Target Changed • Jun 09Price target increased by 17% to US$23.25Up from US$19.83, the current price target is an average from 4 analysts. New target price is 929% above last closing price of US$2.26. Stock is down 23% over the past year. The company is forecast to post a net loss per share of US$1.00 next year compared to a net loss per share of US$1.60 last year.
Major Estimate Revision • May 16Consensus EPS estimates upgraded to US$1.03 lossThe consensus outlook for fiscal year 2023 has been updated. 2023 losses forecast to reduce from -US$1.58 to -US$1.03 per share. Revenue forecast unchanged from US$5.08m at last update. Biotechs industry in the US expected to see average net income decline 85% next year. Consensus price target of US$20.50 unchanged from last update. Share price rose 20% to US$2.57 over the past week.
Recent Insider Transactions • May 12Independent Director recently bought US$450k worth of stockOn the 10th of May, Paul Schimmel bought around 200k shares on-market at roughly US$2.25 per share. This transaction amounted to 25% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$515k more in shares than they have sold in the last 12 months.
分析記事 • May 06Here's Why We're Watching aTyr Pharma's (NASDAQ:LIFE) Cash Burn SituationThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, although Amazon.com...
Major Estimate Revision • Apr 11Consensus revenue estimates fall by 25%The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$6.75m to US$5.08m. Forecast losses increased from -US$1.36 to -US$1.58 per share. Biotechs industry in the US expected to see average net income decline 51% next year. Consensus price target up from US$19.83 to US$20.50. Share price fell 5.2% to US$1.99 over the past week.
Price Target Changed • Mar 02Price target increased by 8.9% to US$22.00Up from US$20.20, the current price target is an average from 5 analysts. New target price is 938% above last closing price of US$2.12. Stock is down 59% over the past year. The company is forecast to post a net loss per share of US$1.82 next year compared to a net loss per share of US$1.77 last year.
Major Estimate Revision • Feb 09Consensus revenue estimates decrease by 25%The consensus outlook for fiscal year 2022 has been updated. 2022 revenue forecast fell from US$500.0k to US$380.0k. EPS estimate unchanged at -US$1.82 per share. Biotechs industry in the US expected to see average net income decline 87% next year. Consensus price target of US$21.20 unchanged from last update. Share price was steady at US$2.20 over the past week.
分析記事 • Jan 04We're Keeping An Eye On aTyr Pharma's (NASDAQ:LIFE) Cash Burn RateEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
Major Estimate Revision • Nov 17Consensus forecasts updatedThe consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$1.00m to US$250.0k. EPS estimate increased from -US$1.84 to -US$1.82 per share. Biotechs industry in the US expected to see average net income decline 94% next year. Consensus price target down from US$22.80 to US$21.20. Share price rose 4.8% to US$2.38 over the past week.
Price Target Changed • Nov 16Price target decreased to US$21.20Down from US$22.80, the current price target is an average from 5 analysts. New target price is 758% above last closing price of US$2.47. Stock is down 71% over the past year. The company is forecast to post a net loss per share of US$1.82 next year compared to a net loss per share of US$1.77 last year.
Board Change • Nov 16Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 6 highly experienced directors. President, CEO & Director Sanjay Shukla was the last director to join the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.
Seeking Alpha • Sep 29aTyr Pharma rises on U.S. patent for anti-neuropilin-2 monoclonal antibodiesaTyr Pharma (NASDAQ:LIFE) said on Thursday the U.S. Patent and Trademark Office had issued a patent covering the company's methods for the use of anti-neuropilin-2 (NRP2) antibodies to treat cancer and inflammation. (LIFE) has risen ~6% before the bell. The blocking antibodies that aTyr has developed target distinct domains of NRP2, including those interacting with semaphorins, VEGF and certain chemokines.
Major Estimate Revision • Sep 14Consensus revenue estimates fall by 67%The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$3.00m to US$1.00m. Forecast losses increased from -US$1.76 to -US$1.84 per share. Biotechs industry in the US expected to see average net income decline 66% next year. Consensus price target of US$22.80 unchanged from last update. Share price fell 3.9% to US$3.42 over the past week.
Seeking Alpha • Sep 13aTyr Pharma stock rises on FDA fast track status for efzofitimod for lung diseaseThe U.S. Food and Drug Administration (FDA) granted fast track designation to aTyr Pharma's (NASDAQ:LIFE) lead drug candidate efzofitimod to treat systemic sclerosis (SSc, also known as scleroderma)-associated, interstitial lung disease (ILD). SSc is a progressive, autoimmune disease characterized by inflammation and scarring of connective tissues in the body. SSc which occurs in the lungs is called SSc-ILD. Clinical proof-of-concept was seen for efzofitimod in a phase 1b/2a trial in patients with pulmonary sarcoidosis, a form of ILD, the company said in a Sept. 13 press release. aTyr noted that it is currently investigating efzofitimod in patients with pulmonary sarcoidosis in a global phase 3 study called EFZO-FIT. The company added that it was the second fast track designation for efzofitimod clinical program and therapy had previously received the FDA's orphan drug designation for SSc LIFE +8.11% to $4.00 premarket Sept. 13
Seeking Alpha • Aug 11aTyr Pharma gains with FDA Fast Track status for lead assetThe shares of clinical-stage biotech aTyr Pharma, Inc. (NASDAQ:LIFE) jumped ~7% in the pre-market Thursday after the company announced that the FDA issued Fast Track designation for its lead candidate efzofitimod for immune-mediated disease, pulmonary sarcoidosis. An immunomodulator, efzofitimod, is designed to downregulate humans' innate and adaptive immune responses. The candidate, also known as ATYR1923, is currently undergoing a global pivotal phase 3 study involving patients with pulmonary sarcoidosis. Sarcoidosis is a leading form of interstitial lung disease, and about 200K Americans are estimated to suffer from pulmonary sarcoidosis. The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at severe conditions with unmet medical needs. It facilitates developers to conduct frequent communications with the regulator on plans for clinical studies. If certain criteria are met, such programs will also be able to win the Accelerated Approval, Priority Review, and Rolling Review, allowing the drugs to reach patients sooner.
Price Target Changed • May 18Price target decreased to US$17.33Down from US$19.00, the current price target is an average from 6 analysts. New target price is 478% above last closing price of US$3.00. Stock is down 26% over the past year. The company is forecast to post a net loss per share of US$1.74 next year compared to a net loss per share of US$1.77 last year.
Major Estimate Revision • May 17Consensus revenue estimates fall by 33%The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$6.22m to US$4.17m. Forecast losses increased from -US$1.35 to -US$1.74 per share. Biotechs industry in the US expected to see average net income decline 52% next year. Consensus price target broadly unchanged at US$18.67. Share price fell 8.0% to US$3.20 over the past week.
分析記事 • May 10We Think aTyr Pharma (NASDAQ:LIFE) Needs To Drive Business Growth CarefullyJust because a business does not make any money, does not mean that the stock will go down. For example, although...
Board Change • Apr 27Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 6 highly experienced directors. President, CEO & Director Sanjay Shukla was the last director to join the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.
Reported Earnings • Mar 15Full year 2021 earnings: EPS and revenues miss analyst expectationsFull year 2021 results: US$1.77 loss per share (up from US$1.77 loss in FY 2020). Net loss: US$33.8m (loss widened 108% from FY 2020). Revenue missed analyst estimates by 100%. Earnings per share (EPS) also missed analyst estimates by 1.3%. Over the last 3 years on average, earnings per share has increased by 79% per year but the company’s share price has fallen by 13% per year, which means it is significantly lagging earnings.
Major Estimate Revision • Mar 15Consensus forecasts updatedThe consensus outlook for 2022 has been updated. 2022 losses forecast to reduce from -US$1.69 to -US$1.43 per share. Revenue forecast unchanged from US$5.08m at last update. Biotechs industry in the US expected to see average net income decline 38% next year. Consensus price target broadly unchanged at US$18.83. Share price fell 2.1% to US$4.75 over the past week.
分析記事 • Jan 24Is aTyr Pharma (NASDAQ:LIFE) In A Good Position To Deliver On Growth Plans?Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
Seeking Alpha • Dec 28aTyr Pharma: Successful Proof Of Concept In Pulmonary SarcoidosisaTyr's lead candidate ATYR1923 recently came out with strong data in a proof of concept trial. Lead indication has a large market in the US. Company is early stage, but looks highly interesting.
Reported Earnings • Nov 12Third quarter 2021 earnings released: US$0.42 loss per share (vs US$0.68 loss in 3Q 2020)Third quarter 2021 results: Net loss: US$7.67m (loss widened 16% from 3Q 2020). Over the last 3 years on average, earnings per share has increased by 80% per year but the company’s share price has only increased by 6% per year, which means it is significantly lagging earnings growth.
Seeking Alpha • Sep 24aTyr Stock Is Buoyant On Highly-Promising Lung Disease Data - Wait For Hype To Die Down And BuyaTyr Pharma produced some surprisingly strong results from recent trials of its lead drug candidate ATYR1923, and its share price has skyrocketed. ATYR1923 is indicated for Pulmonary Sarcoidosis - a ~200k patient population - but could address the $2-$3bn wider ILD market. The company's pipeline is based around founder Paul Schimmel, of the Scripps Institute, and is based around the biology of the extracellular activity of histidyl-tRNA synthetase. It is unique and appears to be quite promising - the company has built an intellectual property portfolio covering >300 protein compositions targeting inflammation, fibrosis and oncology. Analysts have set a consensus price target of ~$19 for aTyr stock, and I would concur that the company ought to be valued >$500m. I would avoid buying now at the peak of the hype cycle, but long term I see >50% upside and perhaps substantially more.
分析記事 • Sep 23Is aTyr Pharma (NASDAQ:LIFE) In A Good Position To Deliver On Growth Plans?Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
Price Target Changed • Sep 14Price target increased to US$19.25Up from US$16.25, the current price target is an average from 4 analysts. New target price is 114% above last closing price of US$9.00. Stock is up 119% over the past year.
Major Estimate Revision • Aug 12Consensus forecasts updatedThe consensus outlook for 2021 has been updated. 2021 revenue forecast increased from US$4.70m to US$5.00m. Forecast EPS reduced from -US$1.84 to -US$2.30 per share. Biotechs industry in the US expected to see average net income decline 21% next year. Consensus price target of US$16.25 unchanged from last update. Share price rose 5.9% to US$4.84 over the past week.
分析記事 • May 22Is aTyr Pharma (NASDAQ:LIFE) In A Good Position To Deliver On Growth Plans?Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
Recent Insider Transactions • May 22Independent Director recently bought US$199k worth of stockOn the 18th of May, Paul Schimmel bought around 50k shares on-market at roughly US$3.98 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$273k more in shares than they have sold in the last 12 months.
