Arcturus Therapeutics Holdings（ARCT）株式概要メッセンジャーRNA医薬品会社であるアークトゥルス・セラピューティクス・ホールディングスは、肝臓と呼吸器の希少疾患治療薬の開発に注力している。 詳細ARCT ファンダメンタル分析スノーフレーク・スコア評価2/6将来の成長2/6過去の実績0/6財務の健全性6/6配当金0/6報酬収益は年間35.74%増加すると予測されています リスク分析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 すべてのリスクチェックを見るARCT Community Fair Values Create NarrativeSee what 50 others think this stock is worth. Follow their fair value or set your own to get alerts.Analyst Price TargetsAN85.6% undervaluedAnalystHighTarget•27d agoSelf-amplifying mRNA Will Meet Aging Global Therapy Demand10705AN1.0% undervaluedAnalystLowTarget•12d agoRevenues Will Fall And Pipeline Risks Will Hinder RNA Upside7701Top Community NarrativesArcturus Therapeutics HoldingsBIbirdflustocksCommunity ContributorArcturus Therapeutics: Strategic opportunities beyond CSLArcturus Therapeutics’ biggest vaccine partner has soured on their relationship, and that fallout could unexpectedly free the company to team up with new pharma giants. The story digs into why this breakup matters, what new partners like Sanofi or BioNTech might want from Arcturus’ RNA platform, and what could still derail the upside.View narrativeUS$30FV73.6% 割安 内在価値ディスカウントSet Fair ValueView209users have viewed this narrative1users have liked this narrative0users have commented on this narrative1users have followed this narrative7 days ago author updated this narrativeTop Community NarrativesArcturus Therapeutics HoldingsBIbirdflustocksCommunity ContributorArcturus Therapeutics: Strategic opportunities beyond CSLArcturus Therapeutics’ biggest vaccine partner has soured on their relationship, and that fallout could unexpectedly free the company to team up with new pharma giants. The story digs into why this breakup matters, what new partners like Sanofi or BioNTech might want from Arcturus’ RNA platform, and what could still derail the upside.View narrativeUS$30FV73.6% 割安 内在価値ディスカウントSet Fair ValueView209users have viewed this narrative1users have liked this narrative0users have commented on this narrative1users have followed this narrative7 days ago author updated this narrativeTop Analyst NarrativesAN85.6% undervaluedAnalystHighTarget•27d agoSelf-amplifying mRNA Will Meet Aging Global Therapy Demand10705AN1.0% undervaluedAnalystLowTarget•12d agoRevenues Will Fall And Pipeline Risks Will Hinder RNA Upside7701View all narrativesArcturus Therapeutics Holdings Inc. 競合他社Caribou BiosciencesSymbol: NasdaqGS:CRBUMarket cap: US$227.0mAlectorSymbol: NasdaqGS:ALECMarket cap: US$245.4mVoyager TherapeuticsSymbol: NasdaqGS:VYGRMarket cap: US$237.5mOpus GeneticsSymbol: NasdaqCM:IRDMarket cap: US$295.6m価格と性能株価の高値、安値、推移の概要Arcturus Therapeutics Holdings過去の株価現在の株価US$7.9252週高値US$24.1752週安値US$5.85ベータ2.431ヶ月の変化-10.71%3ヶ月変化-3.77%1年変化-37.78%3年間の変化-70.74%5年間の変化-74.19%IPOからの変化-20.88%最新ニュース新しいナラティブ • May 22Arcturus Therapeutics: Strategic opportunities beyond CSLCSL has turned a promising collaboration into a significant liability. The pivot away from CSL towards new collaboration partners could multiply the market capitalization of Arcturus Therapeutics.Price Target Changed • May 20Price target decreased by 15% to US$19.89Down from US$23.30, the current price target is an average from 9 analysts. New target price is 192% above last closing price of US$6.82. Stock is down 44% over the past year. The company is forecast to post a net loss per share of US$3.80 next year compared to a net loss per share of US$2.40 last year.ナラティブの更新 • May 17ARCT: Future Returns Will Hinge On Rare Disease Program ExecutionAnalysts updated their price targets on Arcturus Therapeutics to a tighter range around $8, reflecting revised models that trim COVID-related expectations while emphasizing ongoing progress in cystic fibrosis and ornithine transcarbamylase deficiency programs, along with mixed but generally constructive views on the stock's risk and reward profile. Analyst Commentary Street research around Arcturus Therapeutics has tightened around more conservative assumptions, with several bearish analysts trimming price targets and highlighting execution risk around key programs.分析記事 • May 12Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Consensus Forecasts Have Become A Little Darker Since Its Latest ReportAs you might know, Arcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) recently reported its first-quarter numbers...ナラティブの更新 • May 02ARCT: CF And OTCD Pipeline Progress Will Support Future Share Price UpsideAnalysts have adjusted their price targets on Arcturus Therapeutics to a lower range, now spanning roughly $8 to $25, as they recalibrate models following Q4 updates, remove the LUNAR COVID profit share, and balance ongoing execution questions with continued confidence in the ARCT-032 and ARCT-810 programs. Analyst Commentary Recent Street research shows that while price targets on Arcturus Therapeutics have moved to a lower band, some bullish analysts still see room for upside based on the company’s clinical pipeline and execution on key programs.お知らせ • Apr 28Arcturus Therapeutics Holdings Inc. to Report Q1, 2026 Results on May 07, 2026Arcturus Therapeutics Holdings Inc. announced that they will report Q1, 2026 results After-Market on May 07, 2026最新情報をもっと見るRecent updates新しいナラティブ • May 22Arcturus Therapeutics: Strategic opportunities beyond CSLCSL has turned a promising collaboration into a significant liability. The pivot away from CSL towards new collaboration partners could multiply the market capitalization of Arcturus Therapeutics.Price Target Changed • May 20Price target decreased by 15% to US$19.89Down from US$23.30, the current price target is an average from 9 analysts. New target price is 192% above last closing price of US$6.82. Stock is down 44% over the past year. The company is forecast to post a net loss per share of US$3.80 next year compared to a net loss per share of US$2.40 last year.ナラティブの更新 • May 17ARCT: Future Returns Will Hinge On Rare Disease Program ExecutionAnalysts updated their price targets on Arcturus Therapeutics to a tighter range around $8, reflecting revised models that trim COVID-related expectations while emphasizing ongoing progress in cystic fibrosis and ornithine transcarbamylase deficiency programs, along with mixed but generally constructive views on the stock's risk and reward profile. Analyst Commentary Street research around Arcturus Therapeutics has tightened around more conservative assumptions, with several bearish analysts trimming price targets and highlighting execution risk around key programs.分析記事 • May 12Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Consensus Forecasts Have Become A Little Darker Since Its Latest ReportAs you might know, Arcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) recently reported its first-quarter numbers...ナラティブの更新 • May 02ARCT: CF And OTCD Pipeline Progress Will Support Future Share Price UpsideAnalysts have adjusted their price targets on Arcturus Therapeutics to a lower range, now spanning roughly $8 to $25, as they recalibrate models following Q4 updates, remove the LUNAR COVID profit share, and balance ongoing execution questions with continued confidence in the ARCT-032 and ARCT-810 programs. Analyst Commentary Recent Street research shows that while price targets on Arcturus Therapeutics have moved to a lower band, some bullish analysts still see room for upside based on the company’s clinical pipeline and execution on key programs.お知らせ • Apr 28Arcturus Therapeutics Holdings Inc. to Report Q1, 2026 Results on May 07, 2026Arcturus Therapeutics Holdings Inc. announced that they will report Q1, 2026 results After-Market on May 07, 2026お知らせ • Apr 27Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 05, 2026Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 05, 2026.ナラティブの更新 • Apr 18ARCT: Future Execution Risks Will Drive Sensitivity To Pipeline MilestonesAnalysts have modestly adjusted the average price target on Arcturus Therapeutics Holdings, reflecting updated assumptions around program execution, mixed Q4 commentary, and the removal of certain COVID-related profit share contributions, while still citing ongoing interest in cystic fibrosis and ornithine transcarbamylase deficiency programs. Analyst Commentary Recent Street research on Arcturus Therapeutics Holdings reflects a mix of cautious and constructive views, with several firms recalibrating their models after the latest Q4 update.ナラティブの更新 • Apr 02ARCT: Fair Value View Balances Execution Concerns With Pipeline ProgressAnalysts have raised the fair value estimate for Arcturus Therapeutics Holdings to $8.00 from $7.00, based on updated models that incorporate more conservative revenue expectations, higher projected profit margins and recent Street research that reduces longer term targets while still highlighting clinical progress in key programs. Analyst Commentary Recent Street research around Arcturus Therapeutics shows a mix of cautious and constructive views, with several firms revising their models after the latest quarterly update and pipeline commentary.ナラティブの更新 • Mar 19ARCT: CF And OTCD mRNA Pipeline Progress Will Drive Future UpsideAnalysts have reset their models on Arcturus Therapeutics Holdings, cutting the implied fair value estimate from about $72 to about $55 as they factor in more conservative profit margins, a slightly higher discount rate, removal of COVID-related upside, and a sharper focus on the cystic fibrosis and ornithine transcarbamylase deficiency pipelines. Analyst Commentary Recent Street research on Arcturus Therapeutics Holdings shows a wide range of fair value views, but several bullish analysts continue to see upside potential even after cutting price targets and removing COVID-related assumptions from their models.ナラティブの更新 • Mar 04ARCT: Elevated Future P/E Assumptions Will Pressure Execution Risk OutlookAnalysts have raised their price target on Arcturus Therapeutics Holdings to $7.00, reflecting updated assumptions around discount rates, revenue growth, margins and future P/E, supported by a recent bullish initiation from Roth Capital and similar research commentary from other firms. Analyst Commentary While some research has turned more constructive, you are also seeing a thread of caution in recent commentary on Arcturus Therapeutics Holdings.お知らせ • Feb 18Arcturus Therapeutics Holdings Inc. to Report Q4, 2025 Results on Mar 03, 2026Arcturus Therapeutics Holdings Inc. announced that they will report Q4, 2025 results at 4:00 PM, Eastern Standard Time on Mar 03, 2026ナラティブの更新 • Feb 18ARCT: Bullish Coverage And Execution Risks Will Shape Fairly Valued OutlookAnalysts have raised their price target on Arcturus Therapeutics Holdings to $7.00, up from $7, citing a new bullish initiation that highlights the company’s fair value, long term revenue and margin assumptions, and expected future P/E as key supports for the revised view. Analyst Commentary While the new initiation frames US$7.00 as a reasonable reference point, bearish analysts continue to flag risks that could pressure the stock if execution does not line up with the assumptions behind that fair value, especially around long term revenue, margins, and the P/E that is being used in models.Seeking Alpha • Feb 12Arcturus Therapeutics: Two Catalysts, One Runway, And A Stock Priced For FailureSummary Arcturus Therapeutics now centers on ARCT-032 (cystic fibrosis) and ARCT-810 (OTC deficiency), with Covid assets as secondary cash support. ARCT is priced as a busted biotech with optionality; cash runway extends to 2028, but clinical and regulatory risks remain significant. ARCT-032’s 12-week trial and ARCT-810’s FDA alignment are key re-rating catalysts; both programs face pivotal data and regulatory endpoints. Market skepticism is reflected in ARCT’s sub-1 P/BV and low P/S multiples, but positive trial outcomes could drive rapid multiple expansion. Read the full article on Seeking Alphaナラティブの更新 • Feb 02ARCT: Bullish Coverage And Higher Future P/E Will Frame Execution RisksAnalysts have lifted their price target on Arcturus Therapeutics Holdings, pointing to a fair value view of US$7.00 per share. This is supported by a slightly lower discount rate, a more conservative revenue growth outlook and a higher assumed future P/E multiple, with recent bullish Street research helping to justify the updated stance.ナラティブの更新 • Jan 19ARCT: Neutral Downgrade And Fair Value View Will Frame Execution RisksAnalysts reduced their fair value estimate for Arcturus Therapeutics Holdings from US$9.00 to US$7.00, citing updated assumptions for discount rate, revenue growth, profit margin and future P/E following the recent downgrade to Neutral by Street research. Analyst Commentary Bearish analysts are signaling a more cautious stance on Arcturus Therapeutics Holdings, with the recent downgrade to Neutral framing the stock as more of a wait and see situation rather than a clear opportunity at current levels.ナラティブの更新 • Jan 05ARCT: Neutral Downgrade Will Set Up Potential Upside RepricingAnalysts have reduced their price target for Arcturus Therapeutics Holdings from US$42 to US$9, citing updated assumptions for the discount rate, revenue trends, and a lower forward P/E multiple, along with recent rating changes such as the downgrade to Neutral. Analyst Commentary Bearish analysts are signaling a more cautious stance on Arcturus Therapeutics Holdings, with the move to a Neutral rating reinforcing the cut in the price target from US$42 to US$9.お知らせ • Dec 16+ 1 more updateArcturus Therapeutics Holdings Inc. Announces Chief Financial Officer ChangesOn December 11, 2025, Arcturus Therapeutics Holdings Inc. (Company) and Andy Sassine, Chief Financial Officer of the company, mutually agreed to end their employment relationship in an amicable manner effective December 31, 2025. Mr. Sassine indicated to the Company that his separation was not a result of any disagreement with the Company, the Board or the Company’s management on any matter relating to the Company’s operations, policies, or practices. On December 12, 2025, Joe Roberts, age 43, the Company's Controller, was appointed interim principal financial officer and interim principal accounting officer of the Company. Mr. Roberts joined the Company in July 2018 and has held roles of increasing seniority until his appointment as Controller in March 2024. Mr. Roberts was previously a financial analyst with Qualcomm, and an auditor with each of Ernst & Young and Grant Thornton. He received his professional certificate in accounting from the University of California San Diego and his bachelor of arts from the University of California Santa Barbara.ナラティブの更新 • Dec 14ARCT: Orphan mRNA Cystic Fibrosis Program Will Drive Future UpsideAnalysts lowered their price target on Arcturus Therapeutics Holdings to 72 dollars from 128.81 dollars, reflecting a more cautious stance despite higher projected revenue growth and profit margins. They are reassessing valuation multiples and risk following recent rating actions.お知らせ • Nov 13Arcturus Therapeutics Holdings Inc. announced delayed 10-Q filingOn 11/12/2025, Arcturus Therapeutics Holdings Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • Oct 29Arcturus Therapeutics Holdings Inc. to Report Q3, 2025 Results on Nov 10, 2025Arcturus Therapeutics Holdings Inc. announced that they will report Q3, 2025 results After-Market on Nov 10, 2025分析記事 • Oct 28The Market Doesn't Like What It Sees From Arcturus Therapeutics Holdings Inc.'s (NASDAQ:ARCT) Revenues Yet As Shares Tumble 52%Arcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) shares have had a horrible month, losing 52% after a relatively...お知らせ • Oct 22Arcturus Therapeutics Provides Interim Phase 2 Data for Cystic Fibrosis (CF) ProgramArcturus Therapeutics Holdings Inc. announced interim results from its ongoing Phase 2 clinical trial of ARCT-032, an investigational inhaled mRNA therapy for people with cystic fibrosis. In the second cohort of the study, six Class I CF adults received inhaled 10 mg doses of ARCT-032 daily over 28 days. Full FEV1 data tables are available on Arcturus' website. A larger, longer-duration study is planned to substantiate the clinical relevance of these findings. The HRCT mucus reduction and supporting lung function data from the second cohort (10 mg), combined with additional data collected from the ongoing third cohort (15 mg) will guide dose selection, treatment duration, and endpoint strategy for future studies, including the conduct of a 12-week safety and preliminary efficacy clinical trial that is planned to begin in the first half of 2026. Cystic fibrosis is a life-shortening disease with a worldwide distribution. Currently approved CFTR modulator therapies are designed to increase function of the CFTR channel to help reduce symptoms yet are ineffective in some people with CF because of their underlying mutations. ARCT-032 has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) to treat Cystic Fibrosis. ARCT-032 utilizes Arcturus' LUNAR®? lipid-mediated aerosolized platform to deliver CFTR messenger RNA to the lungs. The ARCT-032 program is supported by preclinical data in rodents, ferrets and primates, as well as demonstrating restoration of CFTR expression and function in human bronchial epithelial cells.分析記事 • Aug 29Improved Revenues Required Before Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Stock's 32% Jump Looks JustifiedArcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) shareholders have had their patience rewarded with a 32% share...ナラティブの更新 • Aug 15Late-Stage Trials And Vaccine Partnerships Will Strengthen Market PotentialAnalysts maintained an Overweight rating and reiterated a $47 price target for Arcturus Therapeutics Holdings, citing anticipated positive catalysts from the upcoming Phase 2 Cystic Fibrosis program readout in early Q3, while the consensus analyst price target remained unchanged at $70.89. Analyst Commentary Addition of an "upside 90-day catalyst watch" due to the upcoming Cystic Fibrosis program catalyst expected in early Q3.分析記事 • Jul 31Is Arcturus Therapeutics Holdings (NASDAQ:ARCT) Weighed On By Its Debt Load?Legendary fund manager Li Lu (who Charlie Munger backed) once said, 'The biggest investment risk is not the volatility...お知らせ • Jul 25Arcturus Therapeutics Holdings Inc. to Report Q2, 2025 Results on Aug 11, 2025Arcturus Therapeutics Holdings Inc. announced that they will report Q2, 2025 results at 4:00 PM, Eastern Standard Time on Aug 11, 2025お知らせ • Jul 01Arcturus Therapeutics Holdings Inc. Announces Positive Interim Phase 2 Multiple Dose Data for Ornithine Transcarbamylase (Otc) Deficiency ProgramArcturus Therapeutics Holdings Inc. announced positive Phase 2 interim results in people with OTC deficiency treated with ARCT-810, an mRNA therapeutic candidate designed to replace the OTC enzyme and restore urea cycle activity preventing hyperammonemia crises. Along with the observation of stable ammonia levels in all patients during treatment, these data add a level of robustness to this new interim dataset. The combined biomarker data is unprecedented for an mRNA therapeutic therapeutic and, importantly, provides a potentially accelerated path forward to a multi-biomarkerdriven pivotal study. Multiple dosing data are available from two Phase 2 studies; a completed placebo-controlled study in Europe that randomized six participants to ARCT-810 doses and an open-label multiple ascending dose study with interim data from the initial three completed participants. The ongoing U.S. Phase 2 open-label study uses a modified and improved 15N-ureagenesis assay (Allegri et al., 2025). The assay measures relative ureagenesis function (RUF) against a normal range established from healthy controls (N = 29). ARCT-810 is an intravenously administered investigational mRNA therapeutic designed to express normal functional OTC enzyme in the liver of individuals with OTC deficiency. ARCT-810 has received Orphan Medicinal Product Designation and an approved pediatric investigation plan (PIP) from the European Medicines Agency (EMA), and Orphan Drug Designation, Fast Track Designation along with Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA) for the treatment of OTC deficiency. OTC is a key enzyme in the urea cycle which converts toxic ammonia into urea.お知らせ • Jun 24Arcturus Therapeutics Holdings Inc. to Host Key Opinion Leader Presentation of ARCT-810 Phase 2 Interim Data for Ornithine Transcarbamylase DeficiencyArcturus Therapeutics Holdings Inc. announced that it will host a virtual KOL presentation of ARCT-810 Phase 2 interim data for Ornithine Transcarbamylase (OTC) deficiencyon Monday, June 30, 2025, at 12:00 p.m. ET. The Company will issue a press release summarizing the data at 11 am ET, prior to the presentation. Ornithine transcarbamylase (OTC) deficiency is the most common urea cycle disorder. Urea cycle disorders are a group of inherited metabolic disorders of the liver that make it difficult for affected patients to remove toxic waste products as proteins are digested. OTC deficiency caused by mutations in the X-linked OTC gene, leads to a non-functional or deficient OTC enzyme and usually affects males more severely. OTC is a critical liver enzyme which catalyzes a metabolic process that converts toxic ammonia to urea that is excreted by the kidney. This conversion does not occur properly in patients with OTC deficiency and, aside from the risk of high ammonia levels, leads to increased blood concentrations of glutamine with low to normal levels of citrulline and increases in urine orotic acid. High blood ammonia levels in OTC deficiency may cause health crises with seizures, progressive neurocognitive impairment, coma, and death. Severe cases of OTC deficiency usually present early in life, but patients with less severe symptoms may be diagnosed as adolescents and adults. There is currently no cure for OTC deficiency, apart from liver transplant. However, liver transplantation comes with significant risks of surgical and postsurgical complications such as organ rejection, and recipients must take immunosuppressant drugs for the rest of their lives. The current standard of care for OTC deficiency patients is a well-controlled, but challenging to maintain, low-protein diet, substitution of essential amino acids and treatment with nitrogen scavenging medications that keeps the ammonia from rising to acutely toxic levels but may not prevent chronic neurotoxic effects. These treatments do not address the underlying cause of disease. In Europe and the U.S., approximately 10,000 people have OTC deficiency. ARCT-810 is an intravenously administered investigational mRNA therapeutic designed to express normal functional OTC enzyme in the liver of individuals with OTC deficiency. ARCT-810 has received Orphan Medicinal Product Designation and an approved pediatric investigation plan (PIP) from the European Medicines Agency (EMA), and Orphan Drug Designation, Fast Track Designation along with Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA) for the treatment of OTC deficiency. OTC is a key enzyme in the urea cycle which converts toxic ammonia into urea. Elevated ammonia can lead to metabolic crises with progressive and irreversible neurocognitive damage. A safe and effective mRNA therapeutic may restore normal functional OTC enzyme in the liver which could improve urea cycle activity, reduce abnormally elevated glutamine, maintain normal ammonia levels and potentially eliminate the risk of future metabolic crises. ARCT-810 is based on Arcturus’ mRNA design construct and proprietary manufacturing process. ARCT-810 also utilizes Arcturus’ extensive and propriety lipid library and employs the Company's LUNAR delivery platform to deliver OTC mRNA to hepatocytes.分析記事 • May 04Arcturus Therapeutics Holdings Inc.'s (NASDAQ:ARCT) Price Is Right But Growth Is Lacking After Shares Rocket 41%Arcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) shareholders are no doubt pleased to see that the share price has...お知らせ • Apr 28Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 06, 2025Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 06, 2025.新しいナラティブ • Apr 26KOSTAIVE Approval And Upcoming Vaccine Trials Will Open New Markets European approval of the mRNA COVID-19 vaccine could significantly boost sales through broader market access in 31 countries. お知らせ • Apr 23Arcturus Therapeutics Holdings Inc. to Report Q1, 2025 Results on May 12, 2025Arcturus Therapeutics Holdings Inc. announced that they will report Q1, 2025 results at 4:00 PM, US Eastern Standard Time on May 12, 2025お知らせ • Apr 10Arcturus Therapeutics Holdings Inc. Receives U.S. FDA Fast Track Designation for the STARR®? mRNA Vaccine Candidate ARCT-2304 for Pandemic Influenza A Virus H5N1Arcturus Therapeutics Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the self-amplifying mRNA (sa-mRNA) vaccine candidate, ARCT-2304, designed for active immunization to protect against disease caused by influenza A H5N1 subtype contained in the vaccine. This designation recognizes the potential of ARCT-2304 as an innovative approach to address unmet medical needs for the prevention of disease caused by pandemic influenza A virus H5N1, a significant global health risk. The Phase 1 clinical study initiated in November 2024. Fast Track Designation from the FDA is granted to vaccines intended to prevent serious conditions caused by infectious disease. The designation is designed to expedite the development and review process, providing several benefits, including enhanced communication with the FDA and eligibility for priority review, and the possibility of a rolling review. ARCT-2304, also known as LUNAR-H5N1, is a STARR®? sa-mRNA vaccine candidate formulated with Arcturus proprietary LUNAR®? delivery technology. The sa-mRNA vaccine candidate is designed to make many copies of mRNA within the host cell after intramuscular injection to achieve enhanced expression of haemagglutinin (HA) and neuraminidase (NA) antigens, thereby enabling lower doses than conventional mRNA vaccines. Utilizing a sa-mRNA-based platform for pandemic influenza vaccine development offers further options for meeting domestic vaccine manufacturing surge capacity goals. The technology may make vaccines available much sooner than egg- and cell-based technologies. The lyophilized vaccine formulation is stable in refrigerators, thereby simplifying cold-chain storage and reducing distribution risks.分析記事 • Mar 20Benign Growth For Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Underpins Stock's 26% PlummetArcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) shareholders won't be pleased to see that the share price has had a...分析記事 • Mar 09Analysts Have Lowered Expectations For Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) After Its Latest ResultsArcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) just released its latest yearly report and things are not looking...お知らせ • Feb 25Arcturus Therapeutics Holdings Inc. to Report Q4, 2024 Results on Mar 06, 2025Arcturus Therapeutics Holdings Inc. announced that they will report Q4, 2024 results After-Market on Mar 06, 2025お知らせ • Feb 15CSL and Arcturus Therapeutics Announces Marketing Authorization Grant by European Commission Marketing Authorization for Kostaive (Arct-154), A Self-Amplifying Mrna Covid-19 VaccineCSL and Arcturus Therapeutics announced that the European Commission has granted marketing authorization for KOSTAIVE (ARCT-154), a self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older. KOSTAIVE is the first sa-mRNA COVID-19 vaccine to receive approval from the European Commission (EC). KOSTAIVE is currently marketed in Japan against COVID-19. The European Commission approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on December 12, 2024. CSL - including three businesses: CSL Behring, CSL Seqirus and CSL Vifor - provides lifesaving products to patients in more than 100 countries and employs 32,000 people.お知らせ • Feb 04Arcturus Therapeutics Holdings Inc. Appoints Moncef Slaoui as Chair DesignateArcturus Therapeutics Holdings Inc. announced the appointment of Moncef Slaoui, Ph.D., as Chair Designate. Dr. Slaoui has been serving on the Company’s Board of Directors since June 2024. Dr. Moncef Slaoui was most recently the Chief Scientific Advisor to Operation Warp Speed. Under his leadership the operation enabled the fastest ever development, manufacturing, and approval of multiple COVID-19 vaccines in less than 11 months after the virus genetic sequence was described. Dr. Slaoui has sat on several biotechnology company boards, including Moderna Inc. and Lonza Group AG, and he chaired the boards of Galvani, and Vaxcyte, a vaccine development platform company. Dr. Slaoui spent nearly 30 years at GlaxoSmithKline (GSK) holding leadership positions including as member of the Board of Directors of GSK PLC; Chairman of Pharmaceutical R&D; Chairman Global R&D, Vaccines & Oncology; and Chairman, Global Vaccines. As Chairman of Pharmaceutical R&D, Dr. Slaoui led a redesign of GSK’s R&D structure and culture to improve focus on innovation and productivity. As Chairman of Global Vaccines, Dr. Slaoui was directly involved in GSK's vaccine pipeline, leading to the creation of 14 new vaccines, including Shingrix®, to prevent shingles; Cervarix®, to prevent cervical cancer; Mosquirix, to prevent malaria; Rotarix®, to prevent rotavirus gastroenteritis; and Synflorix, to prevent pneumococcal disease. In 2016, Dr. Slaoui was recognized as one of Fortune's 50 Greatest World Leaders for his work in under-researched diseases common in the developing world. He served on the Advisory Committee to the Director of the NIH from 2011 to 2016 and has advised the U.S. President's Council of Advisors on Science and Technology. Dr. Slaoui holds a Ph.D. in Molecular Biology and Immunology from the Université Libre de Bruxelles, completed postdoctoral studies at Harvard Medical School and Tufts University School of Medicine, and was a Professor of Immunology at the University of Mons, Belgium. He received an accelerated Master of Business Administration from IMD, Switzerland in 1998.Seeking Alpha • Jan 28Arcturus: Downgrading As mRNA Promise Meets Market RealitySummary Arcturus Therapeutics Holdings Inc. stock is down 46% since Sept. 2023 coverage; mRNA sector faces headwinds with public skepticism (35% comfortable with technology) and challenges translating success beyond COVID-19 vaccines. ARCT-810 for OTCD (Phase 2 data 1H '25) must prove IV dosing every 2 weeks is worth better outcomes vs. current treatments; ammonia reduction key measure of success. ARCT-032 for CF (Phase 2 data 1H '25) targets a limited population ineligible for standard care; faces tough competition from Vertex's Trikafta (14% FEV1 improvement). Vaccine programs (COVID/flu) seem commercially challenged; late to market vs. Moderna/Pfizer with no clear differentiation in crowded space. $237M cash ($6.5M monthly burn) provides runway to 2027, but upcoming trial results in 1H '25 critical; downgrading to “sell” until clear differentiation emerges. Read the full article on Seeking Alphaお知らせ • Jan 10Arcturus Therapeutics Announces Initiation of Phase 1 H5N1 Flu Vaccine TrialArcturus Therapeutics Holdings Inc. announced the initiation of the Company's Phase 1 study of ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate, also known as LUNAR-H5N1, for active immunization to prevent pandemic influenza disease caused by H5N1 virus. The randomized placebo-controlled Phase 1 trial (NCT06602531) is being conducted at multiple sites in the U.S. and designed to enroll approximately 200 healthy adults (120 participants 18-59 years old; 80 participants 60-80 years old). The clinical study is fully funded by Biomedical Advanced Research and Development Authority (BARDA). The primary objective of this initial clinical trial is to evaluate safety and immune responses of three different dose levels and two different vaccination schedules of ARCT-2304 vaccine. Immune responses are measured by hemagglutination inhibition (HAI), virus microne neutralization (MN) and neuraminidase enzyme-linkedlectin assays (ELLA). ARCT-2304 (LUNAR-H5N 1) utilizes clinically validated LUNAR®? delivery and STARR®? mRNA platform technologies. STARR®? mRNA has demonstrated in multiple clinical trials its ability to elicit a robust immune response at very low dose levels, with extended persistence of neutralizing antibodies compared to approved conventional mRNA vaccines. The robust safety database of the LUNAR and STARR technologies have been established through multiple COVID-19 and seasonal influenza vaccine trials, which included more than 20,000 participants and dose ranges from 1 to 20 mcg of mRNA. The sa-mRNA vaccine candidate is designed to make many copies of mRNA within the host cell after intramuscular injection to achieve enhanced expression of haemagglutinin (HA) and neuraminidase (NA) antigens, thereby enabling lower doses than conventional mRNA vaccines. Utilizing a mRNA-based platform for pandemic influenza vaccine development offers further options for meeting domestic vaccine manufacturing surge capacity goals. The technology may make vaccines available much sooner than egg- and cell-based technologies. The lyophilized vaccine formulation is stable in refrigerators, thereby simplifying cold-chain storage and reducing distribution risks.お知らせ • Jan 07Arcturus Therapeutics Holdings Inc. Announces Initiation of Dosing in Phase 2 Multiple Ascending Dose Studies for Cystic Fibrosis (CF) and Ornithine Transcarbamylase (OTC) DeficiencyArcturus Therapeutics Holdings Inc. announced that the first CF and OTC deficiency participants initiated dosing in December 2024, in the Company’s Phase 2 multiple ascending dose studies. Each participant in the Phase 2 CF study is expected to receive daily treatments of ARCT-032 over a period of 28 days. The first OTC deficient participant receiving 0.5 mg/kg ARCT-810 initiated dosing in December 2024 in the United States. Each participant is expected to receive five intravenous infusions administered over two months. The Company previously announced the completion of the dosing phase (N = 8; 0.3 mg/kg) in a placebo-controlled European study enrolling OTC deficient individuals and expansion of the Phase 2 clinical program of ARCT-810 into the United States with an open-label multiple-dose study. About Cystic Fibrosis: Cystic fibrosis is a life-shortening disease with a worldwide prevalence. Mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene result in a reduction or absence of CFTR protein and/or function in the airways, causing disruption of ion transport necessary to maintain airway surface homeostasis. CF mucus is more difficult to clear, thus clogging the airways and leading to infection, inflammation, and progressive lung damage that may ultimately result in respiratory failure. Standard of care for many CF individuals include CFTR modulators. Nearly 40,000 people in the U.S. and more than 105,000 people worldwide are living with CF. Approximately 15% of individuals with CF do not benefit from CFTR modulator medicines due to absent CFTR protein and/or drug intolerance. About ARCT-032: ARCT-032 is an inhaled investigational mRNA therapeutic designed to express normal functional CFTR in the lungs of individuals with CF. ARCT-032 has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) and Orphan Drug Designation along with Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA) to treat cystic fibrosis. ARCT-032 utilizes Arcturus’ LUNAR® lipid-mediated aerosolized platform to deliver CFTR messenger RNA to the lungs. Lung disease is the leading cause of morbidity and mortality in people with CF. Expression of a functional copy of the CFTR mRNA in the lungs of people with CF has the potential to restore CFTR activity and mitigate the downstream effects that cause progressive lung disease. The ARCT-032 program is supported by preclinical data in rodents, ferrets and primates, as well as the demonstration of restoration of CFTR expression and function ex-vivo in human bronchial epithelial cells. About Ornithine Transcarbamylase Deficiency: Ornithine transcarbamylase (OTC) deficiency is the most common urea cycle disorder. Urea cycle disorders are a group of inherited metabolic disorders that make it difficult for affected patients to remove toxic waste products as proteins are digested. OTC deficiency is caused by mutations in the OTC gene which leads to a non-functional or deficient OTC enzyme. OTC is a critical liver enzyme which catalyzes an early step in the urea cycle, a metabolic process that converts ammonia to urea. This conversion does not occur properly in patients with OTC deficiency. A deficiency of the OTC enzyme in liver cells can result in high blood ammonia levels and may cause seizures, progressive neurocognitive impairment, coma, and death in untreated patients. OTC deficiency is an inherited X-linked disorder that usually presents early in life, but patients with less severe symptoms may present later in life, as adults. There is currently no cure for OTC deficiency, apart from liver transplant. However, this treatment comes with significant risk of complications such as organ rejection, and transplant recipients must take immunosuppressant drugs for the rest of their lives. The current standard of care for OTC deficiency patients is a well-controlled, but challenging to maintain, low-protein diet and treatment with nitrogen scavenging medications to try to prevent patients from accumulating ammonia. These treatments do not address the underlying cause of disease. In Europe and the U.S., approximately 10,000 people have OTC deficiency. About ARCT-810: ARCT-810 is an intravenously administered investigational mRNA therapeutic designed to express normal functional OTC enzyme in the liver of individuals with OTC deficiency. ARCT-810 has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA), including an approved pediatric investigation plan (PIP), and Orphan Drug Designation along with Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA) for the treatment of ornithine transcarbamylase deficiency. OTC is a key enzyme in the urea cycle which converts toxic ammonia into urea. Elevated ammonia can lead to metabolic crises with progressive and irreversible neurocognitive damage. A safe and effective mRNA therapeutic may restore normal functional OTC enzyme in the liver which could eliminate the risk of future metabolic crises. ARCT-810 is based on Arcturus’ mRNA design construct and proprietary manufacturing process. ARCT-810 also utilizes Arcturus’ extensive and propriety lipid library and employs the Company's LUNAR® delivery platform to deliver OTC mRNA to hepatocytes.Seeking Alpha • Nov 14Arcturus: LUNAR-CF For CF Presses On With 1st Half Of 2025 Interim DataSummary Interim results from phase 2 proof-of-concept study, using LUNAR-CF for treatment of patients with Cystic Fibrosis, expected 1st half of 2025. The global Cystic Fibrosis market size is projected to reach $62.57 billion by 2032. Interim results from phase 2 proof-of-concept study, using LUNAR-OTC for treatment of patients with OTC Deficiency, expected 1st half of 2025. CHMP opinion on KOSATIVE for Covid-19 expected December of 2025; Company has earned up to $462.1 million in milestone and upfront payments from CSL as of September 30th 2024. Read the full article on Seeking Alphaお知らせ • Nov 12Arcturus Therapeutics Holdings Inc. Receives Clearance from FDA to Begin H5N1 Pandemic Flu Vaccine Clinical TrialArcturus Therapeutics Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a "Study Can Proceed" notification for the Company's Investigational New Drug (IND) application, ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus. The clinical study is funded by Biomedical Advanced Research and Development Authority (BARDA) and designed to enroll approximately 200 healthy adults in the United States. ARCT-2304 is a sa-mRNA vaccine candidate formulated within a lipid nanoparticle (LNP). The sa-mRNA vaccine candidate is designed to make many copies of mRNA within the host cell after intramuscular injection to achieve enhanced expression of haemagglutinin (HA) and neuraminidase (NA) antigens, thereby enabling lower doses than conventional mRNA vaccines. Utilizing a mRNA-based platform for pandemic influenza vaccine development offers further options for meeting domestic vaccine manufacturing surge capacity goals. The technology may make vaccines available much sooner than egg- and cell-based technologies. The lyophilized vaccine formulation is stable in refrigerators, thereby simplifying cold-chain storage and reducing distribution risks.お知らせ • Nov 01Arcturus Therapeutics Holdings Inc. to Report Q3, 2024 Results on Nov 07, 2024Arcturus Therapeutics Holdings Inc. announced that they will report Q3, 2024 results After-Market on Nov 07, 2024分析記事 • Oct 04Improved Revenues Required Before Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Stock's 28% Jump Looks JustifiedArcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) shareholders would be excited to see that the share price has had a...お知らせ • Sep 14Japan's Ministry of Health, Labor and Welfare Approves CSL and Arcturus Therapeutics Holdings Inc.'s Updated Self-Amplifying mRNA Covid-19 Vaccine for Protection Against JN.1 StrainCSL and Arcturus Therapeutics Holdings Inc. announced that Japan's Ministry of Health, Labor and Welfare (MHLWs) granted approval and authorization for their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE. The updated vaccine is targeted to protect against the JN.1 lineage of Omicron subvariants for adults 18 years of age and older. CSL's exclusive partner in Japan, Meiji Seika Pharma, will begin distributing the updated vaccine in time for the October COVID-19 vaccination campaign, marking the commercially available sa-mRNA COVID-19 vaccine for adults 18 and older. In May 2024, a Japanese health ministry panel recommended that COVID-19 vaccines be updated to target the JN.1 lineage of Omicron subvariants for the 2024/2025 national immunization program. This aligns with recent recommendations from the World Health Organization. The approval is based on clinical evidence supporting the safety and effectiveness of CSL and Arcturus Therapeutics’ sa-mRNA COVID-19 vaccine, including published data demonstrating superior immunogenicity to Omicron BA 4/5 compared to a conventional mRNA COVID-19 vaccine booster and follow-up data demonstrating duration of immunity lasting up to one year.分析記事 • Sep 06Here's Why We're Not Too Worried About Arcturus Therapeutics Holdings' (NASDAQ:ARCT) Cash Burn SituationJust because a business does not make any money, does not mean that the stock will go down. For example, although...お知らせ • Sep 03Arcturus Therapeutics Holdings Inc. Receives Clearance of an Investigational New Drug Application to U.S. Food and Drug Administration for ARCT-032, an Investigational Inhaled mRNA Therapeutic to Treat Cystic FibrosisArcturus Therapeutics Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a "Study May Proceed" notification for the Company's Investigational New Drug (IND) application, ARCT-032, to treat cystic fibrosis (CF). FDA clearance of the ARCT-032 IND application enables the Company to initiate a Phase 2 multiple ascending dose study to evaluate the safety, tolerability and efficacy of ARCT-032 in people with Cystic Fibrosis. Cystic fibrosis is a life-shortening disease with a worldwide prevalence. Mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene result in a reduction or absence of CFTR protein and/or function in the airways, causing insufficient chloride transport to maintain airway surface homeostasis. CF mucus is more difficult to clear, thus clogging the airways and leading to infection, inflammation, respiratory failure, or other life-threatening complications. Standard of care for many CF individuals include CFTR modulators. Nearly 40,000 people in the U.S. and more than 105,000 people worldwide are living with CF. Approximately 15% of individuals with CF do not benefit from CFTR modulator medicines due to dysfunctional or absent CFTR protein and/or drug intolerance. ARCT-032 is an inhaled investigational mRNA therapeutic designed to express normal functional CFTR in the lungs of individuals with CF. ARCT-032 has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) and Orphan Drug Designation along with Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA) to treat cystic fibrosis. ARCT-032 utilizes Arcturus' LUNAR lipid-mediated aerosolized platform to deliver CFTR messenger RNA to the lungs. Lung disease is the leading cause of morbidity and mortality in people with CF. Expression of a functional copy of the CFTR mRNA in the lungs of people with CF has the potential to restore CFTR activity and mitigate the downstream effects that cause progressive lung disease. The ARCT-032 program is supported by preclinical data in rodents, ferrets and primates, as well as demonstrating restoration of CFTR expression and function in human bronchial epithelial cells.Seeking Alpha • Aug 09High-Risk, High-Reward: Arcturus Nears Commercialization Of Kostaive VaccineSummary Arcturus is close to launching the Kostaive COVID-19 vaccine in Japan, with ongoing work on variant protection and influenza vaccine. The company has been able to consistently derive research revenues, maintaining liquidity and avoiding debt, with potential for significant revenue from vaccine orders. Valuation suggests Arcturus may be undervalued compared to peers, with a revised model showing potential for significant revenue growth by 2026. Read the full article on Seeking Alphaお知らせ • Jul 19Arcturus Therapeutics Holdings Inc. to Report Q2, 2024 Results on Aug 05, 2024Arcturus Therapeutics Holdings Inc. announced that they will report Q2, 2024 results After-Market on Aug 05, 2024お知らせ • Jul 02Arcturus Therapeutics Holdings Inc. Provides Updates for Ornithine Transcarbamylase (OTC) Deficiency and Cystic Fibrosis (CF) ProgramsArcturus Therapeutics Holdings Inc. announced it is providing mid-year updates for ARCT-810, an investigational mRNA therapeutic to treat ornithine transcarbamylase (OTC) deficiency, and ARCT-032, an investigational inhaled mRNA therapeutic to treat cystic fibrosis (CF). ARCT-810 (OTC Deficiency) Update: The double blind ARCT-810 Phase 2 study in the EU and UK has completed enrollment of eight (8) subjects, including adolescents and adults, at the 0.3 mg/kg dose level. The participants in this group are randomized 3:1 and receive 6 doses of ARCT-810 or placebo administered every 14 days. Treatment and follow-up are ongoing with the safety and complete set of biomarker data expected later this year. ARCT-810 is expanding the Company’s clinical program in the U.S. by enrolling patients with more severe disease. Patient screening has been initiated and the Company expects the Phase 2 clinical program to be completed in the United States. More details pertaining to the U.S. trial expansion and interim data will be provided later this year. ARCT-032 (CF) Update: The Company plans to submit an IND application in the next 60 days for an ARCT-032 Phase 2 multiple ascending dose study designed to identify a safe and effective dose in Class I (null) and other CF participants who do not benefit from CFTR modulators. This study is supported by safety and tolerability data collected in healthy volunteers (N = 32) and the ongoing two-administration Phase 1b study. No serious adverse events (SAEs) have been observed in any clinical trial participants to date. No febrile reactions have been observed within the target dose range of the planned Phase 2 study. The Phase 1b study is ongoing with the seventh and final participant scheduled to be dosed soon. Of the seven total CF participants in Phase 1b, six are receiving CFTR modulator treatment while one subject has Class I mutations and therefore does not benefit from modulator therapy. The Class I CF subject had low lung function at baseline (ppFEV1 below 50%) and showed an improvement of 4% in ppFEV1 on Day 8, after receiving two well-tolerated administrations, with no febrile reactions.お知らせ • Jun 20Arcturus Therapeutics Holdings Inc. Appoints Moncef Slaoui, Ph.D., to Board of DirectorsArcturus Therapeutics Holdings Inc. announced the appointment of a new independent director, Moncef Slaoui, Ph.D., to the Company's Board of Directors. Dr. Moncef Slaoui was most recently the Chief Scientific Advisor to Operation Warp Speed. Under his leadership the operation enabled the fastest ever development, manufacturing, and approval of multiple COVID-19 vaccines in less than 11 months after the virus genetic sequence was described. Dr. Slaoui has sat on several biotechnology company boards, including Moderna Inc. and Lonza Group AG, and he chaired the boards of Galvani, and Vaxcyte, a vaccine development platform company. Dr. Slaoui spent nearly 30 years at GlaxoSmithKline (GSK) holding leadership positions including as member of the Board of Directors of GSK PLC; Chairman of Pharmaceutical R&D; Chairman Global R&D, Vaccines & Oncology; and Chairman, Global Vaccines. As Chairman of Pharmaceutical R&D, Dr. Slaoui led a restructuring to improve focus on innovation and productivity. As Chairman of Global Vaccines, Dr. Slaoui was directly involved in GSK's vaccine pipeline, leading to the creation of 14 new vaccines, including Shingrix®, to prevent shingles; Cervarix®, to prevent cervical cancer; Mosquirix, to prevent malaria; Rotarix®, to prevent rotavirus gastroenteritis; and Synflorix, to prevent pneumococcal disease. In 2016, Dr. Slaoui was recognized as one of Fortune's 50 Greatest World Leaders for his work in under-researched diseases common in the developing world, served on the Advisory Committee to the Director of the NIH from 2011 to 2016, and has advised the U.S. President's Council of Advisors on Science and Technology. Dr. Slaoui holds a Ph.D. in Molecular Biology and Immunology from the Université Libre de Bruxelles, completed postdoctoral studies at Harvard Medical School and Tufts University School of Medicine, and was a Professor of Immunology at the University of Mons, Belgium. He received an accelerated Master of Business Administration from IMD, Switzerland in 1998.Seeking Alpha • Jun 08Arcturus: A Hidden Gem In The Biotech SectorSummary Arcturus is a top pick in the biotech sector with a strong stock market performance. The company generates revenue from research and development partnerships, which helps conserve cash. The launch of the Kostaive vaccine and other programs are expected to drive revenue growth in the short and long term. Read the full article on Seeking Alphaお知らせ • May 29Arcturus Therapeutics Holdings Inc. Announces Positive Development for Cystic Fibrosis ProgramArcturus Therapeutics Holdings Inc. announced ARCT-032 will be presenting Phase 1 results in healthy volunteers and new Phase 1b interim data in CF patients for ARCT-032, an inhaled investigational mRNA therapeutic to treat CF, at the 47thEuropean Cystic Fibrosis Conference on June 7, 2024. Arcturus will be presented Phase 1 results in healthy volunteers. ARCT-032 has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) to treat Cystic Fibrosis. ARCT-032 utilizes Arcturus' LUNAR lipid-mediated aerosolized platform to deliver CFTR messenger RNA to the lungs. The ARCT-032 program is supported by preclinical data in rodents, ferrets and primates, as well as demonstrating restoration of CFTR expression and function in human bronchial epithelial cells.分析記事 • May 29Arcturus Therapeutics Holdings Inc.'s (NASDAQ:ARCT) Share Price Boosted 45% But Its Business Prospects Need A Lift TooArcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) shareholders are no doubt pleased to see that the share price has...New Risk • May 28New 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. This is currently the only risk that has been identified for the company.お知らせ • May 23Nature Communications Publishes Pivotal Data Demonstrating Efficacy and Tolerability of CSL and Arcturus Therapeutics' COVID-19 VaccineCSL and Arcturus Therapeutics announced Nature Communications has published results from an integrated phase 1/2/3a/3b study evaluating the safety, immunogenicity, and efficacy of ARCT, 154, a novel self-amplifying (sa-mRNA) COVID-19 vaccine and the world's first approved sa-mRNA COVID-19 vaccine. The results demonstrate that two 5 mg doses of ARCT-154, sa-mRNA vaccine, were well-tolerated, immunogenic and provided significant protection against multiple strains of COVID-19. The efficacy of ARCT-154 against severe COVID-19 was 100% in healthy persons aged 18-59 and more than 90% in persons at risk of severe consequences of the disease due to co-morbidities or older age. During the observer-blind, randomized, controlled phase 1, 2, 3a and 3b integrated study, adults =18 years old receive two 5 µg doses of ARCT-154 or saline placebo 28 days apart. Phase 2/3a/3b participants were stratified by age (< 60 or = 60 years of age) and by risk of severe COVID-19 prior to being randomized 3:1 (phase 1/2/3a) or 1:1 (phase 3b) to vaccine or placebo groups. The primary endpoints were vaccine efficacy up to 2 months after dose 2, reactogenicity within up to 7 days of each dose, safety within up to 28 days after each dose, and immunogenicity measured 28 days after each dose From August 15 to January 12, 2023, 1,001 participants were randomized (748 ARCT-154 and 253 placebo) in the integrated phase 1/2/3a study, and 16,100 participants (8,056 ARCT-154 and 8,044 placebo) in the phase 3b study. In the phase 1/2/3a studies, ARCT-154 was safe and well tolerated. Most solicited adverse events were mild or moderate and resolved quickly, and rates of related or severe unsolicited adverse events were similar in the ARCT-154 and placebo groups. The phase 3b study confirmed these observations. Four weeks after the second ARCT-154 dose in phase 3b, the neutralizing antibody seroconversion rate was 94.1% (95% CI: 92•1–95•8). There were 640 confirmed, protocol-defined COVID-19 cases, mainly of the Delta variant, that were determined to be eligible for analysis, including 43 severe cases and 10 deaths attributed to COVID-19. ARCT-154 absolute efficacy was 56.6% (95% CI: 48.7– 63.3) against any COVID-19, 95•3% (80.5–98.9) against severe COVID-19 and 86.5% (-7.4–98.3) against death due to COVID-19. Efficacy against severe COVID-19 was 100% in healthy 18-59-year-olds and 91.9% (37.9-98.9) in participants in that age group with underlying co-morbidities, which put them at risk for severe disease. In adults aged 60 years or older, efficacy was 54.3% (28.2–70.9) against COVID-19 of any severity and 94.4% (58.2–99.3) against severe COVID-19.Major Estimate Revision • May 15Consensus revenue estimates increase by 24%, EPS downgradedThe consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$147.0m to US$181.8m. EPS estimate fell from -US$2.61 to -US$2.99 per share. Biotechs industry in the US expected to see average net income decline 9.7% next year. Consensus price target up from US$67.93 to US$72.29. Share price rose 6.6% to US$29.02 over the past week.Reported Earnings • May 09First quarter 2024 earnings: EPS and revenues exceed analyst expectationsFirst quarter 2024 results: US$1.00 loss per share (down from US$1.91 profit in 1Q 2023). Revenue: US$38.0m (down 53% from 1Q 2023). Net loss: US$26.8m (down 153% from profit in 1Q 2023). Revenue exceeded analyst estimates by 115%. Earnings per share (EPS) also surpassed analyst estimates by 19%. Revenue is forecast to grow 41% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 64% per year but the company’s share price has only increased by 2% per year, which means it is significantly lagging earnings growth.お知らせ • May 01Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 14, 2024Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 14, 2024, at 09:00 Pacific Standard Time. Agenda: To elect Dr. Peter Farrell, Joseph E. Payne, Andy Sassine, James Barlow, Dr. Edward W. Holmes, Dr. Magda Marquet, Dr. Jing L. Marantz, and Dr. John Markels to the Board of Directors (the “Board”), to serve until our next annual meeting of stockholders; to approve an amendment to the Amended and Restated 2019 Omnibus Equity Incentive Plan (as amended, the “Plan”) to, among other things, increase the maximum number of shares of common stock available to Plan participants thereunder by 2,000,000 shares to an aggregate of 10,750,000 shares; to approve, on a non-binding advisory basis, the resolution approving named executive officer compensation; to ratify the appointment of Deloitte & Touche LLP (“Deloitte”), as an independent registered public accounting firm for the fiscal year ending December 31, 2024; and to transact other business that may properly come before the annual meeting.お知らせ • Apr 28Arcturus Therapeutics Holdings Inc. to Report Q1, 2024 Results on May 08, 2024Arcturus Therapeutics Holdings Inc. announced that they will report Q1, 2024 results After-Market on May 08, 2024Seeking Alpha • Apr 23Arcturus Therapeutics' ARCT-032: Might Be The Next Breakthrough In Cystic FibrosisSummary Arcturus Therapeutics' ARCT-032 gene therapy for cystic fibrosis has been designated as an "orphan drug" in the U.S. and Europe. The therapy has the potential to generate significant revenues, similar to Vertex Pharmaceuticals' Trikafta treatment. ARCT's financial status is currently unstable, but the company has the potential to become profitable with the success of ARCT-032 and other therapies. Read the full article on Seeking Alpha分析記事 • Apr 09Arcturus Therapeutics Holdings (NASDAQ:ARCT) Is In A Strong Position To Grow Its BusinessJust because a business does not make any money, does not mean that the stock will go down. For example, although...Major Estimate Revision • Mar 24Consensus EPS estimates fall by 20%The consensus outlook for earnings per share (EPS) in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$166.7m to US$150.8m. Losses expected to increase from US$2.05 per share to US$2.46. Biotechs industry in the US expected to see average net income decline 9.2% next year. Consensus price target of US$67.89 unchanged from last update. Share price fell 6.6% to US$33.90 over the past week.Recent Insider Transactions Derivative • Mar 21Founder notifies of intention to sell stockPadmanabh Chivukula intends to sell 26k shares in the next 90 days after lodging an Intent To Sell Form on the 19th of March. If the sale is conducted around the recent share price of US$35.00, it would amount to US$910k. Since June 2023, Padmanabh's direct individual holding has decreased from 549.45k shares to 499.45k. Company insiders have collectively sold US$315k more than they bought, via options and on-market transactions in the last 12 months.Major Estimate Revision • Mar 14Consensus EPS estimates upgraded to US$2.19 lossThe consensus outlook for fiscal year 2024 has been updated. 2024 losses forecast to reduce from -US$3.33 to -US$2.19 per share. Revenue forecast steady at US$163.2m. Biotechs industry in the US expected to see average net income decline 8.3% next year. Consensus price target up from US$66.33 to US$67.89. Share price was steady at US$37.90 over the past week.Reported Earnings • Mar 09Full year 2023 earnings: EPS exceeds analyst expectations while revenues lag behindFull year 2023 results: US$1.00 loss per share (down from US$0.35 profit in FY 2022). Revenue: US$169.9m (down 18% from FY 2022). Net loss: US$26.6m (down 384% from profit in FY 2022). Revenue missed analyst estimates by 2.2%. Earnings per share (EPS) exceeded analyst estimates by 35%. Revenue is forecast to grow 35% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 70% per year but the company’s share price has fallen by 9% per year, which means it is significantly lagging earnings.Valuation Update With 7 Day Price Move • Feb 28Investor sentiment improves as stock rises 22%After last week's 22% share price gain to US$42.99, the stock trades at a trailing P/E ratio of 11.6x. Average trailing P/E is 14x in the Biotechs industry in the US. Total loss to shareholders of 15% over the past three years.お知らせ • Feb 21Arcturus Therapeutics Holdings Inc. to Report Q4, 2023 Results on Mar 07, 2024Arcturus Therapeutics Holdings Inc. announced that they will report Q4, 2023 results After-Market on Mar 07, 2024Price Target Changed • Feb 09Price target increased by 8.0% to US$66.33Up from US$61.44, the current price target is an average from 9 analysts. New target price is 75% above last closing price of US$37.91. Stock is up 100% over the past year. The company is forecast to post a net loss per share of US$1.53 compared to earnings per share of US$0.35 last year.分析記事 • Feb 06Arcturus Therapeutics Holdings Inc.'s (NASDAQ:ARCT) Price Is Right But Growth Is LackingWith a price-to-sales (or "P/S") ratio of 3.2x Arcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) may be sending very...Seeking Alpha • Jan 31Arcturus: H1 2024 Rare Disease Drug Data On DeckSummary Arcturus Therapeutics Holdings Inc. interim results from the phase 1b study, using ARCT-032 for the treatment of patients with Cystic Fibrosis, are expected in the 1st half of 2024. The global Cystic Fibrosis market is projected to grow to $12.9 billion by 2030. Interim results from the phase 2 study, using ARCT-810 for the treatment of patients with OTC Deficiency, are expected in the 1st half of 2024. Received approval with partner CSL in Japan for ARCT-154 as the first self-amplifying mRNA vaccine for adults with COVID-19. Read the full article on Seeking Alpha分析記事 • Jan 11Does Arcturus Therapeutics Holdings (NASDAQ:ARCT) Have A Healthy Balance Sheet?Howard Marks put it nicely when he said that, rather than worrying about share price volatility, 'The possibility of...お知らせ • Dec 21CSL and Arcturus Therapeutics' ARCT-154 Demonstrates Non-Inferiority to Original Strain and Superior Immunogenicity to Omicronba BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster BoosterCSL and Arcturus Therapeutics announced the publication in Lancet Infectious Diseases of a Phase 3 study showing that a booster dose of ARCT-154, a novel, self-amplifying messenger RNA (sa-mRNA) vaccine, expedited a numerically higher immune response (meeting the non-inferiority criteria) against the original Wuhan-Hu-1 virus strain, and a superior immune response against Omicron BA.4/5 subvariant of SARS-CoV-2 virus compared to a booster dose of the conventional mRNA vaccine Comirnaty. The study included healthy adults initially immunized with two doses of an mRNA vaccine (Comirnaty or Spikevax); and then a third dose of Comirnaty at least three months prior to the booster dose of either ARCT-154 or Comirnaty in the study. Both vaccines were well-tolerated, with no causally associated severe or serious adverse events. The study was conducted in partnership with Meiji Seika Pharma, a global health company based in Japan. The phase 3 study results with ARCT-154 were used to support the approval of ARCT-154 for primary immunization and as a booster dose in Japan in November of this year. The ARCT-154 study is ongoing and will continue to collect safety data and assess durability of the immune response in participants at 3-, 6- and 12-months post-vaccination. The randomized, double-blind, active-controlled study, conducted at 11 sites in Japan, was designed to compare the immunogenicity and tolerability of the sa-mRNA vaccine ARCT-154 with authorized mRNA COVID-19 vaccine Comirnaty. Investigators compared immune responses to ARCT-154 and Comirnaty booster doses in healthy Japanese adults 18 years of age or older initially immunized with two dose of mRNA COVID-19 vaccine (Comirnaty or Spikevax) and then a third dose ofComirnaty at least three months prior to receiving a booster dose of one of the study vaccines.Valuation Update With 7 Day Price Move • Dec 20Investor sentiment improves as stock rises 25%After last week's 25% share price gain to US$32.41, the stock trades at a trailing P/E ratio of 8.7x. Average forward P/E is 18x in the Biotechs industry in the US. Total loss to shareholders of 68% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at US$47.95 per share.分析記事 • Dec 14Are Investors Undervaluing Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) By 46%?Key Insights Arcturus Therapeutics Holdings' estimated fair value is US$47.95 based on 2 Stage Free Cash Flow to Equity...お知らせ • Nov 29Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics' ARCT-154, the First Self-Amplifying mRNA Vaccine Approves for COVID in AdultsCSL and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval forARCT-154, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older. The approval is based on positive clinical data from several ARCT-154 studies, including an ongoing 16,000 subject efficacy study performed in Vietnam as well as a Phase 3 COVID-19 booster trial, which achieved higher immunogenicity results and a favorable safety profile compared to a standard mRNA COVID-19 vaccine comparison. Initial study results have been published in MedRxiv and are expected to be published in a peer-reviewed journal by the end of the year. CSL's vaccine business, CSL Seqirus, one of the largest influenza vaccine providers in the world, partnered exclusively with Meiji Seika Pharma for distribution of the sa-mRNA COVID vaccine, ARCT 154, in Japan.Major Estimate Revision • Nov 22Consensus revenue estimates increase by 27%The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$136.7m to US$174.0m. Forecast losses expected to reduce from -US$2.84 to -US$1.54 per share. Biotechs industry in the US expected to see average net income growth of 10% next year. Consensus price target broadly unchanged at US$61.44. Share price was steady at US$22.94 over the past week.Reported Earnings • Nov 16Third quarter 2023 earnings: EPS and revenues exceed analyst expectationsThird quarter 2023 results: US$0.61 loss per share (improved from US$1.33 loss in 3Q 2022). Revenue: US$45.1m (up 238% from 3Q 2022). Net loss: US$16.2m (loss narrowed 54% from 3Q 2022). Revenue exceeded analyst estimates by 185%. Earnings per share (EPS) also surpassed analyst estimates by 63%. Revenue is expected to decline by 1.4% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 15%. Over the last 3 years on average, earnings per share has increased by 61% per year but the company’s share price has fallen by 26% per year, which means it is significantly lagging earnings.お知らせ • Oct 26Arcturus Therapeutics Holdings Inc. to Report Q3, 2023 Results on Nov 14, 2023Arcturus Therapeutics Holdings Inc. announced that they will report Q3, 2023 results After-Market on Nov 14, 2023Recent Insider Transactions Derivative • Oct 04Founder notifies of intention to sell stockPadmanabh Chivukula intends to sell 15k shares in the next 90 days after lodging an Intent To Sell Form on the 2nd of October. If the sale is conducted around the recent share price of US$26.00, it would amount to US$390k. Since March 2023, Padmanabh's direct individual holding has decreased from 589.45k shares to 509.45k. Company insiders have collectively sold US$233k more than they bought, via options and on-market transactions in the last 12 months.お知らせ • Sep 27+ 1 more updateArcturus Therapeutics Holdings Inc. announced that it has received $25 million in funding from Cystic Fibrosis FoundationArcturus Therapeutics Holdings Inc. announced that it has raised up to $9 million in a round of funding on September 26, 2023. The transaction will include participation from returning investor, Cystic Fibrosis Foundation. On the same day, the company amended the terms of the transaction and it raised up to $25 million.分析記事 • Sep 14Arcturus Therapeutics Holdings Inc.'s (NASDAQ:ARCT) Shares Lagging The Industry But So Is The BusinessArcturus Therapeutics Holdings Inc.'s ( NASDAQ:ARCT ) price-to-sales (or "P/S") ratio of 2.9x might make it look like a...お知らせ • Sep 06Arcturus Therapeutics Holdings Inc. and Csl Seqirus Announce European Medicines Agency Validates Marketing Authorization Application for Arct-154 Vaccine to Prevent Covid-19Arcturus Therapeutics Holdings Inc. and CSL announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for ARCT-154, a next generation mRNA vaccine, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The companies (Arcturus and CSL Seqirus) anticipate an approval decision by the European Commission in 2024. The EMA submission is based on successful Phase 3 clinical results of ARCT-154 against the ancestral D614G variant as a primary series and booster. In an analysis of 6-month data from the pivotal Phase 3 study, the primary efficacy endpoint was met and ARCT-154 as a primary series resulted in 56.6% efficacy for prevention of symptomatic COVID-19 overall, and 95.3% efficacy for prevention of severe COVID-19 including COVID-19 related deaths. The study was conducted when Delta variant was dominant in Vietnam. The booster data result was previously announced by CSL Seqirus' partner, Meiji Seika Pharma, indicating that the primary endpoint was achieved in a Phase 3 booster vaccine study by demonstrating non-inferiority of immune response against SARS-CoV- 2 ancestral strain compared to Comirnaty®?. Superiority of ARCT-154 in neutralizing antibody response against SARS- CoV-2 Omicron BA.4/5 variant was a key secondary endpoint. The unique combination of commercial strength, R&D focus and operational excellence enables to identify, develop and deliver innovations so patients can live life to the fullest.Recent Insider Transactions Derivative • Sep 03Founder notifies of intention to sell stockPadmanabh Chivukula intends to sell 5k shares in the next 90 days after lodging an Intent To Sell Form on the 1st of September. If the sale is conducted around the recent share price of US$31.00, it would amount to US$155k. Since March 2023, Padmanabh's direct individual holding has decreased from 589.45k shares to 514.45k. Company insiders have collectively sold US$233k more than they bought, via options and on-market transactions in the last 12 months.Valuation Update With 7 Day Price Move • Aug 15Investor sentiment improves as stock rises 16%After last week's 16% share price gain to US$29.94, the stock trades at a trailing P/E ratio of 9.9x. Average forward P/E is 12x in the Biotechs industry in the US. Total loss to shareholders of 47% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at US$48.37 per share.Major Estimate Revision • Aug 14Consensus revenue estimates fall by 17%The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$174.9m to US$145.5m. Forecast losses increased from -US$0.697 to -US$2.16 per share. Biotechs industry in the US expected to see average net income decline 13% next year. Consensus price target of US$60.44 unchanged from last update. Share price fell 13% to US$27.77 over the past week.New Risk • Aug 09New 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: Minor Risks Share price has been volatile over the past 3 months (10% average weekly change). Large one-off items impacting financial results.Reported Earnings • Aug 08Second quarter 2023 earnings: EPS and revenues miss analyst expectationsSecond quarter 2023 results: US$1.98 loss per share (further deteriorated from US$0.82 loss in 2Q 2022). Revenue: US$10.5m (down 61% from 2Q 2022). Net loss: US$52.6m (loss widened 144% from 2Q 2022). Revenue missed analyst estimates by 79%. Earnings per share (EPS) also missed analyst estimates significantly. Revenue is forecast to grow 35% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 38% per year but the company’s share price has fallen by 19% per year, which means it is significantly lagging earnings.Buying Opportunity • Aug 08Now 32% undervalued after recent price dropOver the last 90 days, the stock is down 13%. The fair value is estimated to be US$37.63, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 119% over the last 3 years. Meanwhile, the company has become profitable. For the next 3 years, revenue is forecast to grow by 35% per annum. Earnings is also forecast to grow by 48% per annum over the same time period.分析記事 • Aug 08Some Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Analysts Just Made A Major Cut To Next Year's EstimatesToday is shaping up negative for Arcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) shareholders, with the analysts...Recent Insider Transactions Derivative • Aug 03Founder notifies of intention to sell stockPadmanabh Chivukula intends to sell 5k shares in the next 90 days after lodging an Intent To Sell Form on the 1st of August. If the sale is conducted around the recent share price of US$35.00, it would amount to US$175k. Since March 2023, Padmanabh's direct individual holding has decreased from 589.45k shares to 519.45k. Company insiders have collectively sold US$233k more than they bought, via options and on-market transactions in the last 12 months.お知らせ • Jul 25Arcturus Therapeutics Holdings Inc. to Report Q2, 2023 Results on Aug 07, 2023Arcturus Therapeutics Holdings Inc. announced that they will report Q2, 2023 results After-Market on Aug 07, 2023分析記事 • Jul 19Calculating The Fair Value Of Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT)Key Insights Using the 2 Stage Free Cash Flow to Equity, Arcturus Therapeutics Holdings fair value estimate is US$33.33...Recent Insider Transactions Derivative • Jul 17Founder notifies of intention to sell stockPadmanabh Chivukula intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 14th of July. If the sale is conducted around the recent share price of US$30.81, it would amount to US$770k. Since March 2023, Padmanabh's direct individual holding has decreased from 589.45k shares to 544.45k. Company insiders have collectively sold US$51k more than they bought, via options and on-market transactions in the last 12 months.株主還元ARCTUS BiotechsUS 市場7D12.8%1.3%1.8%1Y-37.8%33.0%28.4%株主還元を見る業界別リターン: ARCT過去 1 年間で33 % 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: ARCTは、過去 1 年間で28.4 % のリターンを上げたUS市場を下回りました。価格変動Is ARCT's price volatile compared to industry and market?ARCT volatilityARCT Average Weekly Movement8.6%Biotechs Industry Average Movement10.8%Market Average Movement7.2%10% most volatile stocks in US Market16.7%10% least volatile stocks in US Market3.0%安定した株価: ARCT 、 US市場と比較して、過去 3 か月間で大きな価格変動はありませんでした。時間の経過による変動: ARCTの 週次ボラティリティ ( 9% ) は過去 1 年間安定しています。会社概要設立従業員CEO（最高経営責任者ウェブサイト2013109Joe Paynearcturusrx.comArcturus Therapeutics Holdings Inc.はメッセンジャーRNA医薬品の会社で、肝臓と呼吸器の希少疾患治療薬の開発に注力している。同社の技術プラットフォームには、自己増幅型mRNA技術プラットフォームであるSTARRと、脂質を介した送達システムであるLUNARがある。また、嚢胞性線維症に対するmRNA治療薬候補で臨床第2相開発中のARCT-032（LUNAR-CF）、オルニチン・トランスカルバミラーゼ（OTC）欠損症に対する臨床第2相開発中のARCT-810（LUNAR-OTC）を開発している。さらに、COVID-19の自己増幅型RNAワクチンであるKOSTAIVE、季節性インフルエンザの治療薬として臨床第1相試験中のARCT-2138（LUNAR-FLU）、パンデミックインフルエンザの治療薬として臨床第1相試験中のARCT-2304（LUNAR-H5N1）を開発している。アクトゥルス・セラピューティクス・ホールディングスは2013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Arcturus Therapeutics Holdings Inc. 基礎のまとめArcturus Therapeutics Holdings の収益と売上を時価総額と比較するとどうか。ARCT 基礎統計学時価総額US$217.72m収益（TTM）-US$78.67m売上高(TTM)US$54.71m4.1xP/Sレシオ-2.9xPER（株価収益率ARCT 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ARCT 損益計算書（TTM）収益US$54.71m売上原価US$98.85m売上総利益-US$44.14mその他の費用US$34.54m収益-US$78.67m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）-2.77グロス・マージン-80.67%純利益率-143.80%有利子負債／自己資本比率0%ARCT 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2026/05/28 16:34終値2026/05/28 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Arcturus Therapeutics Holdings Inc. 12 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。23 アナリスト機関Huidong WangBarclaysMayank MamtaniB. Riley Securities, Inc.Thomas ShraderBTIG20 その他のアナリストを表示
新しいナラティブ • May 22Arcturus Therapeutics: Strategic opportunities beyond CSLCSL has turned a promising collaboration into a significant liability. The pivot away from CSL towards new collaboration partners could multiply the market capitalization of Arcturus Therapeutics.
Price Target Changed • May 20Price target decreased by 15% to US$19.89Down from US$23.30, the current price target is an average from 9 analysts. New target price is 192% above last closing price of US$6.82. Stock is down 44% over the past year. The company is forecast to post a net loss per share of US$3.80 next year compared to a net loss per share of US$2.40 last year.
ナラティブの更新 • May 17ARCT: Future Returns Will Hinge On Rare Disease Program ExecutionAnalysts updated their price targets on Arcturus Therapeutics to a tighter range around $8, reflecting revised models that trim COVID-related expectations while emphasizing ongoing progress in cystic fibrosis and ornithine transcarbamylase deficiency programs, along with mixed but generally constructive views on the stock's risk and reward profile. Analyst Commentary Street research around Arcturus Therapeutics has tightened around more conservative assumptions, with several bearish analysts trimming price targets and highlighting execution risk around key programs.
分析記事 • May 12Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Consensus Forecasts Have Become A Little Darker Since Its Latest ReportAs you might know, Arcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) recently reported its first-quarter numbers...
ナラティブの更新 • May 02ARCT: CF And OTCD Pipeline Progress Will Support Future Share Price UpsideAnalysts have adjusted their price targets on Arcturus Therapeutics to a lower range, now spanning roughly $8 to $25, as they recalibrate models following Q4 updates, remove the LUNAR COVID profit share, and balance ongoing execution questions with continued confidence in the ARCT-032 and ARCT-810 programs. Analyst Commentary Recent Street research shows that while price targets on Arcturus Therapeutics have moved to a lower band, some bullish analysts still see room for upside based on the company’s clinical pipeline and execution on key programs.
お知らせ • Apr 28Arcturus Therapeutics Holdings Inc. to Report Q1, 2026 Results on May 07, 2026Arcturus Therapeutics Holdings Inc. announced that they will report Q1, 2026 results After-Market on May 07, 2026
新しいナラティブ • May 22Arcturus Therapeutics: Strategic opportunities beyond CSLCSL has turned a promising collaboration into a significant liability. The pivot away from CSL towards new collaboration partners could multiply the market capitalization of Arcturus Therapeutics.
Price Target Changed • May 20Price target decreased by 15% to US$19.89Down from US$23.30, the current price target is an average from 9 analysts. New target price is 192% above last closing price of US$6.82. Stock is down 44% over the past year. The company is forecast to post a net loss per share of US$3.80 next year compared to a net loss per share of US$2.40 last year.
ナラティブの更新 • May 17ARCT: Future Returns Will Hinge On Rare Disease Program ExecutionAnalysts updated their price targets on Arcturus Therapeutics to a tighter range around $8, reflecting revised models that trim COVID-related expectations while emphasizing ongoing progress in cystic fibrosis and ornithine transcarbamylase deficiency programs, along with mixed but generally constructive views on the stock's risk and reward profile. Analyst Commentary Street research around Arcturus Therapeutics has tightened around more conservative assumptions, with several bearish analysts trimming price targets and highlighting execution risk around key programs.
分析記事 • May 12Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Consensus Forecasts Have Become A Little Darker Since Its Latest ReportAs you might know, Arcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) recently reported its first-quarter numbers...
ナラティブの更新 • May 02ARCT: CF And OTCD Pipeline Progress Will Support Future Share Price UpsideAnalysts have adjusted their price targets on Arcturus Therapeutics to a lower range, now spanning roughly $8 to $25, as they recalibrate models following Q4 updates, remove the LUNAR COVID profit share, and balance ongoing execution questions with continued confidence in the ARCT-032 and ARCT-810 programs. Analyst Commentary Recent Street research shows that while price targets on Arcturus Therapeutics have moved to a lower band, some bullish analysts still see room for upside based on the company’s clinical pipeline and execution on key programs.
お知らせ • Apr 28Arcturus Therapeutics Holdings Inc. to Report Q1, 2026 Results on May 07, 2026Arcturus Therapeutics Holdings Inc. announced that they will report Q1, 2026 results After-Market on May 07, 2026
お知らせ • Apr 27Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 05, 2026Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 05, 2026.
ナラティブの更新 • Apr 18ARCT: Future Execution Risks Will Drive Sensitivity To Pipeline MilestonesAnalysts have modestly adjusted the average price target on Arcturus Therapeutics Holdings, reflecting updated assumptions around program execution, mixed Q4 commentary, and the removal of certain COVID-related profit share contributions, while still citing ongoing interest in cystic fibrosis and ornithine transcarbamylase deficiency programs. Analyst Commentary Recent Street research on Arcturus Therapeutics Holdings reflects a mix of cautious and constructive views, with several firms recalibrating their models after the latest Q4 update.
ナラティブの更新 • Apr 02ARCT: Fair Value View Balances Execution Concerns With Pipeline ProgressAnalysts have raised the fair value estimate for Arcturus Therapeutics Holdings to $8.00 from $7.00, based on updated models that incorporate more conservative revenue expectations, higher projected profit margins and recent Street research that reduces longer term targets while still highlighting clinical progress in key programs. Analyst Commentary Recent Street research around Arcturus Therapeutics shows a mix of cautious and constructive views, with several firms revising their models after the latest quarterly update and pipeline commentary.
ナラティブの更新 • Mar 19ARCT: CF And OTCD mRNA Pipeline Progress Will Drive Future UpsideAnalysts have reset their models on Arcturus Therapeutics Holdings, cutting the implied fair value estimate from about $72 to about $55 as they factor in more conservative profit margins, a slightly higher discount rate, removal of COVID-related upside, and a sharper focus on the cystic fibrosis and ornithine transcarbamylase deficiency pipelines. Analyst Commentary Recent Street research on Arcturus Therapeutics Holdings shows a wide range of fair value views, but several bullish analysts continue to see upside potential even after cutting price targets and removing COVID-related assumptions from their models.
ナラティブの更新 • Mar 04ARCT: Elevated Future P/E Assumptions Will Pressure Execution Risk OutlookAnalysts have raised their price target on Arcturus Therapeutics Holdings to $7.00, reflecting updated assumptions around discount rates, revenue growth, margins and future P/E, supported by a recent bullish initiation from Roth Capital and similar research commentary from other firms. Analyst Commentary While some research has turned more constructive, you are also seeing a thread of caution in recent commentary on Arcturus Therapeutics Holdings.
お知らせ • Feb 18Arcturus Therapeutics Holdings Inc. to Report Q4, 2025 Results on Mar 03, 2026Arcturus Therapeutics Holdings Inc. announced that they will report Q4, 2025 results at 4:00 PM, Eastern Standard Time on Mar 03, 2026
ナラティブの更新 • Feb 18ARCT: Bullish Coverage And Execution Risks Will Shape Fairly Valued OutlookAnalysts have raised their price target on Arcturus Therapeutics Holdings to $7.00, up from $7, citing a new bullish initiation that highlights the company’s fair value, long term revenue and margin assumptions, and expected future P/E as key supports for the revised view. Analyst Commentary While the new initiation frames US$7.00 as a reasonable reference point, bearish analysts continue to flag risks that could pressure the stock if execution does not line up with the assumptions behind that fair value, especially around long term revenue, margins, and the P/E that is being used in models.
Seeking Alpha • Feb 12Arcturus Therapeutics: Two Catalysts, One Runway, And A Stock Priced For FailureSummary Arcturus Therapeutics now centers on ARCT-032 (cystic fibrosis) and ARCT-810 (OTC deficiency), with Covid assets as secondary cash support. ARCT is priced as a busted biotech with optionality; cash runway extends to 2028, but clinical and regulatory risks remain significant. ARCT-032’s 12-week trial and ARCT-810’s FDA alignment are key re-rating catalysts; both programs face pivotal data and regulatory endpoints. Market skepticism is reflected in ARCT’s sub-1 P/BV and low P/S multiples, but positive trial outcomes could drive rapid multiple expansion. Read the full article on Seeking Alpha
ナラティブの更新 • Feb 02ARCT: Bullish Coverage And Higher Future P/E Will Frame Execution RisksAnalysts have lifted their price target on Arcturus Therapeutics Holdings, pointing to a fair value view of US$7.00 per share. This is supported by a slightly lower discount rate, a more conservative revenue growth outlook and a higher assumed future P/E multiple, with recent bullish Street research helping to justify the updated stance.
ナラティブの更新 • Jan 19ARCT: Neutral Downgrade And Fair Value View Will Frame Execution RisksAnalysts reduced their fair value estimate for Arcturus Therapeutics Holdings from US$9.00 to US$7.00, citing updated assumptions for discount rate, revenue growth, profit margin and future P/E following the recent downgrade to Neutral by Street research. Analyst Commentary Bearish analysts are signaling a more cautious stance on Arcturus Therapeutics Holdings, with the recent downgrade to Neutral framing the stock as more of a wait and see situation rather than a clear opportunity at current levels.
ナラティブの更新 • Jan 05ARCT: Neutral Downgrade Will Set Up Potential Upside RepricingAnalysts have reduced their price target for Arcturus Therapeutics Holdings from US$42 to US$9, citing updated assumptions for the discount rate, revenue trends, and a lower forward P/E multiple, along with recent rating changes such as the downgrade to Neutral. Analyst Commentary Bearish analysts are signaling a more cautious stance on Arcturus Therapeutics Holdings, with the move to a Neutral rating reinforcing the cut in the price target from US$42 to US$9.
お知らせ • Dec 16+ 1 more updateArcturus Therapeutics Holdings Inc. Announces Chief Financial Officer ChangesOn December 11, 2025, Arcturus Therapeutics Holdings Inc. (Company) and Andy Sassine, Chief Financial Officer of the company, mutually agreed to end their employment relationship in an amicable manner effective December 31, 2025. Mr. Sassine indicated to the Company that his separation was not a result of any disagreement with the Company, the Board or the Company’s management on any matter relating to the Company’s operations, policies, or practices. On December 12, 2025, Joe Roberts, age 43, the Company's Controller, was appointed interim principal financial officer and interim principal accounting officer of the Company. Mr. Roberts joined the Company in July 2018 and has held roles of increasing seniority until his appointment as Controller in March 2024. Mr. Roberts was previously a financial analyst with Qualcomm, and an auditor with each of Ernst & Young and Grant Thornton. He received his professional certificate in accounting from the University of California San Diego and his bachelor of arts from the University of California Santa Barbara.
ナラティブの更新 • Dec 14ARCT: Orphan mRNA Cystic Fibrosis Program Will Drive Future UpsideAnalysts lowered their price target on Arcturus Therapeutics Holdings to 72 dollars from 128.81 dollars, reflecting a more cautious stance despite higher projected revenue growth and profit margins. They are reassessing valuation multiples and risk following recent rating actions.
お知らせ • Nov 13Arcturus Therapeutics Holdings Inc. announced delayed 10-Q filingOn 11/12/2025, Arcturus Therapeutics Holdings Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • Oct 29Arcturus Therapeutics Holdings Inc. to Report Q3, 2025 Results on Nov 10, 2025Arcturus Therapeutics Holdings Inc. announced that they will report Q3, 2025 results After-Market on Nov 10, 2025
分析記事 • Oct 28The Market Doesn't Like What It Sees From Arcturus Therapeutics Holdings Inc.'s (NASDAQ:ARCT) Revenues Yet As Shares Tumble 52%Arcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) shares have had a horrible month, losing 52% after a relatively...
お知らせ • Oct 22Arcturus Therapeutics Provides Interim Phase 2 Data for Cystic Fibrosis (CF) ProgramArcturus Therapeutics Holdings Inc. announced interim results from its ongoing Phase 2 clinical trial of ARCT-032, an investigational inhaled mRNA therapy for people with cystic fibrosis. In the second cohort of the study, six Class I CF adults received inhaled 10 mg doses of ARCT-032 daily over 28 days. Full FEV1 data tables are available on Arcturus' website. A larger, longer-duration study is planned to substantiate the clinical relevance of these findings. The HRCT mucus reduction and supporting lung function data from the second cohort (10 mg), combined with additional data collected from the ongoing third cohort (15 mg) will guide dose selection, treatment duration, and endpoint strategy for future studies, including the conduct of a 12-week safety and preliminary efficacy clinical trial that is planned to begin in the first half of 2026. Cystic fibrosis is a life-shortening disease with a worldwide distribution. Currently approved CFTR modulator therapies are designed to increase function of the CFTR channel to help reduce symptoms yet are ineffective in some people with CF because of their underlying mutations. ARCT-032 has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) to treat Cystic Fibrosis. ARCT-032 utilizes Arcturus' LUNAR®? lipid-mediated aerosolized platform to deliver CFTR messenger RNA to the lungs. The ARCT-032 program is supported by preclinical data in rodents, ferrets and primates, as well as demonstrating restoration of CFTR expression and function in human bronchial epithelial cells.
分析記事 • Aug 29Improved Revenues Required Before Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Stock's 32% Jump Looks JustifiedArcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) shareholders have had their patience rewarded with a 32% share...
ナラティブの更新 • Aug 15Late-Stage Trials And Vaccine Partnerships Will Strengthen Market PotentialAnalysts maintained an Overweight rating and reiterated a $47 price target for Arcturus Therapeutics Holdings, citing anticipated positive catalysts from the upcoming Phase 2 Cystic Fibrosis program readout in early Q3, while the consensus analyst price target remained unchanged at $70.89. Analyst Commentary Addition of an "upside 90-day catalyst watch" due to the upcoming Cystic Fibrosis program catalyst expected in early Q3.
分析記事 • Jul 31Is Arcturus Therapeutics Holdings (NASDAQ:ARCT) Weighed On By Its Debt Load?Legendary fund manager Li Lu (who Charlie Munger backed) once said, 'The biggest investment risk is not the volatility...
お知らせ • Jul 25Arcturus Therapeutics Holdings Inc. to Report Q2, 2025 Results on Aug 11, 2025Arcturus Therapeutics Holdings Inc. announced that they will report Q2, 2025 results at 4:00 PM, Eastern Standard Time on Aug 11, 2025
お知らせ • Jul 01Arcturus Therapeutics Holdings Inc. Announces Positive Interim Phase 2 Multiple Dose Data for Ornithine Transcarbamylase (Otc) Deficiency ProgramArcturus Therapeutics Holdings Inc. announced positive Phase 2 interim results in people with OTC deficiency treated with ARCT-810, an mRNA therapeutic candidate designed to replace the OTC enzyme and restore urea cycle activity preventing hyperammonemia crises. Along with the observation of stable ammonia levels in all patients during treatment, these data add a level of robustness to this new interim dataset. The combined biomarker data is unprecedented for an mRNA therapeutic therapeutic and, importantly, provides a potentially accelerated path forward to a multi-biomarkerdriven pivotal study. Multiple dosing data are available from two Phase 2 studies; a completed placebo-controlled study in Europe that randomized six participants to ARCT-810 doses and an open-label multiple ascending dose study with interim data from the initial three completed participants. The ongoing U.S. Phase 2 open-label study uses a modified and improved 15N-ureagenesis assay (Allegri et al., 2025). The assay measures relative ureagenesis function (RUF) against a normal range established from healthy controls (N = 29). ARCT-810 is an intravenously administered investigational mRNA therapeutic designed to express normal functional OTC enzyme in the liver of individuals with OTC deficiency. ARCT-810 has received Orphan Medicinal Product Designation and an approved pediatric investigation plan (PIP) from the European Medicines Agency (EMA), and Orphan Drug Designation, Fast Track Designation along with Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA) for the treatment of OTC deficiency. OTC is a key enzyme in the urea cycle which converts toxic ammonia into urea.
お知らせ • Jun 24Arcturus Therapeutics Holdings Inc. to Host Key Opinion Leader Presentation of ARCT-810 Phase 2 Interim Data for Ornithine Transcarbamylase DeficiencyArcturus Therapeutics Holdings Inc. announced that it will host a virtual KOL presentation of ARCT-810 Phase 2 interim data for Ornithine Transcarbamylase (OTC) deficiencyon Monday, June 30, 2025, at 12:00 p.m. ET. The Company will issue a press release summarizing the data at 11 am ET, prior to the presentation. Ornithine transcarbamylase (OTC) deficiency is the most common urea cycle disorder. Urea cycle disorders are a group of inherited metabolic disorders of the liver that make it difficult for affected patients to remove toxic waste products as proteins are digested. OTC deficiency caused by mutations in the X-linked OTC gene, leads to a non-functional or deficient OTC enzyme and usually affects males more severely. OTC is a critical liver enzyme which catalyzes a metabolic process that converts toxic ammonia to urea that is excreted by the kidney. This conversion does not occur properly in patients with OTC deficiency and, aside from the risk of high ammonia levels, leads to increased blood concentrations of glutamine with low to normal levels of citrulline and increases in urine orotic acid. High blood ammonia levels in OTC deficiency may cause health crises with seizures, progressive neurocognitive impairment, coma, and death. Severe cases of OTC deficiency usually present early in life, but patients with less severe symptoms may be diagnosed as adolescents and adults. There is currently no cure for OTC deficiency, apart from liver transplant. However, liver transplantation comes with significant risks of surgical and postsurgical complications such as organ rejection, and recipients must take immunosuppressant drugs for the rest of their lives. The current standard of care for OTC deficiency patients is a well-controlled, but challenging to maintain, low-protein diet, substitution of essential amino acids and treatment with nitrogen scavenging medications that keeps the ammonia from rising to acutely toxic levels but may not prevent chronic neurotoxic effects. These treatments do not address the underlying cause of disease. In Europe and the U.S., approximately 10,000 people have OTC deficiency. ARCT-810 is an intravenously administered investigational mRNA therapeutic designed to express normal functional OTC enzyme in the liver of individuals with OTC deficiency. ARCT-810 has received Orphan Medicinal Product Designation and an approved pediatric investigation plan (PIP) from the European Medicines Agency (EMA), and Orphan Drug Designation, Fast Track Designation along with Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA) for the treatment of OTC deficiency. OTC is a key enzyme in the urea cycle which converts toxic ammonia into urea. Elevated ammonia can lead to metabolic crises with progressive and irreversible neurocognitive damage. A safe and effective mRNA therapeutic may restore normal functional OTC enzyme in the liver which could improve urea cycle activity, reduce abnormally elevated glutamine, maintain normal ammonia levels and potentially eliminate the risk of future metabolic crises. ARCT-810 is based on Arcturus’ mRNA design construct and proprietary manufacturing process. ARCT-810 also utilizes Arcturus’ extensive and propriety lipid library and employs the Company's LUNAR delivery platform to deliver OTC mRNA to hepatocytes.
分析記事 • May 04Arcturus Therapeutics Holdings Inc.'s (NASDAQ:ARCT) Price Is Right But Growth Is Lacking After Shares Rocket 41%Arcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) shareholders are no doubt pleased to see that the share price has...
お知らせ • Apr 28Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 06, 2025Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 06, 2025.
新しいナラティブ • Apr 26KOSTAIVE Approval And Upcoming Vaccine Trials Will Open New Markets European approval of the mRNA COVID-19 vaccine could significantly boost sales through broader market access in 31 countries.
お知らせ • Apr 23Arcturus Therapeutics Holdings Inc. to Report Q1, 2025 Results on May 12, 2025Arcturus Therapeutics Holdings Inc. announced that they will report Q1, 2025 results at 4:00 PM, US Eastern Standard Time on May 12, 2025
お知らせ • Apr 10Arcturus Therapeutics Holdings Inc. Receives U.S. FDA Fast Track Designation for the STARR®? mRNA Vaccine Candidate ARCT-2304 for Pandemic Influenza A Virus H5N1Arcturus Therapeutics Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the self-amplifying mRNA (sa-mRNA) vaccine candidate, ARCT-2304, designed for active immunization to protect against disease caused by influenza A H5N1 subtype contained in the vaccine. This designation recognizes the potential of ARCT-2304 as an innovative approach to address unmet medical needs for the prevention of disease caused by pandemic influenza A virus H5N1, a significant global health risk. The Phase 1 clinical study initiated in November 2024. Fast Track Designation from the FDA is granted to vaccines intended to prevent serious conditions caused by infectious disease. The designation is designed to expedite the development and review process, providing several benefits, including enhanced communication with the FDA and eligibility for priority review, and the possibility of a rolling review. ARCT-2304, also known as LUNAR-H5N1, is a STARR®? sa-mRNA vaccine candidate formulated with Arcturus proprietary LUNAR®? delivery technology. The sa-mRNA vaccine candidate is designed to make many copies of mRNA within the host cell after intramuscular injection to achieve enhanced expression of haemagglutinin (HA) and neuraminidase (NA) antigens, thereby enabling lower doses than conventional mRNA vaccines. Utilizing a sa-mRNA-based platform for pandemic influenza vaccine development offers further options for meeting domestic vaccine manufacturing surge capacity goals. The technology may make vaccines available much sooner than egg- and cell-based technologies. The lyophilized vaccine formulation is stable in refrigerators, thereby simplifying cold-chain storage and reducing distribution risks.
分析記事 • Mar 20Benign Growth For Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Underpins Stock's 26% PlummetArcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) shareholders won't be pleased to see that the share price has had a...
分析記事 • Mar 09Analysts Have Lowered Expectations For Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) After Its Latest ResultsArcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) just released its latest yearly report and things are not looking...
お知らせ • Feb 25Arcturus Therapeutics Holdings Inc. to Report Q4, 2024 Results on Mar 06, 2025Arcturus Therapeutics Holdings Inc. announced that they will report Q4, 2024 results After-Market on Mar 06, 2025
お知らせ • Feb 15CSL and Arcturus Therapeutics Announces Marketing Authorization Grant by European Commission Marketing Authorization for Kostaive (Arct-154), A Self-Amplifying Mrna Covid-19 VaccineCSL and Arcturus Therapeutics announced that the European Commission has granted marketing authorization for KOSTAIVE (ARCT-154), a self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older. KOSTAIVE is the first sa-mRNA COVID-19 vaccine to receive approval from the European Commission (EC). KOSTAIVE is currently marketed in Japan against COVID-19. The European Commission approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on December 12, 2024. CSL - including three businesses: CSL Behring, CSL Seqirus and CSL Vifor - provides lifesaving products to patients in more than 100 countries and employs 32,000 people.
お知らせ • Feb 04Arcturus Therapeutics Holdings Inc. Appoints Moncef Slaoui as Chair DesignateArcturus Therapeutics Holdings Inc. announced the appointment of Moncef Slaoui, Ph.D., as Chair Designate. Dr. Slaoui has been serving on the Company’s Board of Directors since June 2024. Dr. Moncef Slaoui was most recently the Chief Scientific Advisor to Operation Warp Speed. Under his leadership the operation enabled the fastest ever development, manufacturing, and approval of multiple COVID-19 vaccines in less than 11 months after the virus genetic sequence was described. Dr. Slaoui has sat on several biotechnology company boards, including Moderna Inc. and Lonza Group AG, and he chaired the boards of Galvani, and Vaxcyte, a vaccine development platform company. Dr. Slaoui spent nearly 30 years at GlaxoSmithKline (GSK) holding leadership positions including as member of the Board of Directors of GSK PLC; Chairman of Pharmaceutical R&D; Chairman Global R&D, Vaccines & Oncology; and Chairman, Global Vaccines. As Chairman of Pharmaceutical R&D, Dr. Slaoui led a redesign of GSK’s R&D structure and culture to improve focus on innovation and productivity. As Chairman of Global Vaccines, Dr. Slaoui was directly involved in GSK's vaccine pipeline, leading to the creation of 14 new vaccines, including Shingrix®, to prevent shingles; Cervarix®, to prevent cervical cancer; Mosquirix, to prevent malaria; Rotarix®, to prevent rotavirus gastroenteritis; and Synflorix, to prevent pneumococcal disease. In 2016, Dr. Slaoui was recognized as one of Fortune's 50 Greatest World Leaders for his work in under-researched diseases common in the developing world. He served on the Advisory Committee to the Director of the NIH from 2011 to 2016 and has advised the U.S. President's Council of Advisors on Science and Technology. Dr. Slaoui holds a Ph.D. in Molecular Biology and Immunology from the Université Libre de Bruxelles, completed postdoctoral studies at Harvard Medical School and Tufts University School of Medicine, and was a Professor of Immunology at the University of Mons, Belgium. He received an accelerated Master of Business Administration from IMD, Switzerland in 1998.
Seeking Alpha • Jan 28Arcturus: Downgrading As mRNA Promise Meets Market RealitySummary Arcturus Therapeutics Holdings Inc. stock is down 46% since Sept. 2023 coverage; mRNA sector faces headwinds with public skepticism (35% comfortable with technology) and challenges translating success beyond COVID-19 vaccines. ARCT-810 for OTCD (Phase 2 data 1H '25) must prove IV dosing every 2 weeks is worth better outcomes vs. current treatments; ammonia reduction key measure of success. ARCT-032 for CF (Phase 2 data 1H '25) targets a limited population ineligible for standard care; faces tough competition from Vertex's Trikafta (14% FEV1 improvement). Vaccine programs (COVID/flu) seem commercially challenged; late to market vs. Moderna/Pfizer with no clear differentiation in crowded space. $237M cash ($6.5M monthly burn) provides runway to 2027, but upcoming trial results in 1H '25 critical; downgrading to “sell” until clear differentiation emerges. Read the full article on Seeking Alpha
お知らせ • Jan 10Arcturus Therapeutics Announces Initiation of Phase 1 H5N1 Flu Vaccine TrialArcturus Therapeutics Holdings Inc. announced the initiation of the Company's Phase 1 study of ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate, also known as LUNAR-H5N1, for active immunization to prevent pandemic influenza disease caused by H5N1 virus. The randomized placebo-controlled Phase 1 trial (NCT06602531) is being conducted at multiple sites in the U.S. and designed to enroll approximately 200 healthy adults (120 participants 18-59 years old; 80 participants 60-80 years old). The clinical study is fully funded by Biomedical Advanced Research and Development Authority (BARDA). The primary objective of this initial clinical trial is to evaluate safety and immune responses of three different dose levels and two different vaccination schedules of ARCT-2304 vaccine. Immune responses are measured by hemagglutination inhibition (HAI), virus microne neutralization (MN) and neuraminidase enzyme-linkedlectin assays (ELLA). ARCT-2304 (LUNAR-H5N 1) utilizes clinically validated LUNAR®? delivery and STARR®? mRNA platform technologies. STARR®? mRNA has demonstrated in multiple clinical trials its ability to elicit a robust immune response at very low dose levels, with extended persistence of neutralizing antibodies compared to approved conventional mRNA vaccines. The robust safety database of the LUNAR and STARR technologies have been established through multiple COVID-19 and seasonal influenza vaccine trials, which included more than 20,000 participants and dose ranges from 1 to 20 mcg of mRNA. The sa-mRNA vaccine candidate is designed to make many copies of mRNA within the host cell after intramuscular injection to achieve enhanced expression of haemagglutinin (HA) and neuraminidase (NA) antigens, thereby enabling lower doses than conventional mRNA vaccines. Utilizing a mRNA-based platform for pandemic influenza vaccine development offers further options for meeting domestic vaccine manufacturing surge capacity goals. The technology may make vaccines available much sooner than egg- and cell-based technologies. The lyophilized vaccine formulation is stable in refrigerators, thereby simplifying cold-chain storage and reducing distribution risks.
お知らせ • Jan 07Arcturus Therapeutics Holdings Inc. Announces Initiation of Dosing in Phase 2 Multiple Ascending Dose Studies for Cystic Fibrosis (CF) and Ornithine Transcarbamylase (OTC) DeficiencyArcturus Therapeutics Holdings Inc. announced that the first CF and OTC deficiency participants initiated dosing in December 2024, in the Company’s Phase 2 multiple ascending dose studies. Each participant in the Phase 2 CF study is expected to receive daily treatments of ARCT-032 over a period of 28 days. The first OTC deficient participant receiving 0.5 mg/kg ARCT-810 initiated dosing in December 2024 in the United States. Each participant is expected to receive five intravenous infusions administered over two months. The Company previously announced the completion of the dosing phase (N = 8; 0.3 mg/kg) in a placebo-controlled European study enrolling OTC deficient individuals and expansion of the Phase 2 clinical program of ARCT-810 into the United States with an open-label multiple-dose study. About Cystic Fibrosis: Cystic fibrosis is a life-shortening disease with a worldwide prevalence. Mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene result in a reduction or absence of CFTR protein and/or function in the airways, causing disruption of ion transport necessary to maintain airway surface homeostasis. CF mucus is more difficult to clear, thus clogging the airways and leading to infection, inflammation, and progressive lung damage that may ultimately result in respiratory failure. Standard of care for many CF individuals include CFTR modulators. Nearly 40,000 people in the U.S. and more than 105,000 people worldwide are living with CF. Approximately 15% of individuals with CF do not benefit from CFTR modulator medicines due to absent CFTR protein and/or drug intolerance. About ARCT-032: ARCT-032 is an inhaled investigational mRNA therapeutic designed to express normal functional CFTR in the lungs of individuals with CF. ARCT-032 has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) and Orphan Drug Designation along with Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA) to treat cystic fibrosis. ARCT-032 utilizes Arcturus’ LUNAR® lipid-mediated aerosolized platform to deliver CFTR messenger RNA to the lungs. Lung disease is the leading cause of morbidity and mortality in people with CF. Expression of a functional copy of the CFTR mRNA in the lungs of people with CF has the potential to restore CFTR activity and mitigate the downstream effects that cause progressive lung disease. The ARCT-032 program is supported by preclinical data in rodents, ferrets and primates, as well as the demonstration of restoration of CFTR expression and function ex-vivo in human bronchial epithelial cells. About Ornithine Transcarbamylase Deficiency: Ornithine transcarbamylase (OTC) deficiency is the most common urea cycle disorder. Urea cycle disorders are a group of inherited metabolic disorders that make it difficult for affected patients to remove toxic waste products as proteins are digested. OTC deficiency is caused by mutations in the OTC gene which leads to a non-functional or deficient OTC enzyme. OTC is a critical liver enzyme which catalyzes an early step in the urea cycle, a metabolic process that converts ammonia to urea. This conversion does not occur properly in patients with OTC deficiency. A deficiency of the OTC enzyme in liver cells can result in high blood ammonia levels and may cause seizures, progressive neurocognitive impairment, coma, and death in untreated patients. OTC deficiency is an inherited X-linked disorder that usually presents early in life, but patients with less severe symptoms may present later in life, as adults. There is currently no cure for OTC deficiency, apart from liver transplant. However, this treatment comes with significant risk of complications such as organ rejection, and transplant recipients must take immunosuppressant drugs for the rest of their lives. The current standard of care for OTC deficiency patients is a well-controlled, but challenging to maintain, low-protein diet and treatment with nitrogen scavenging medications to try to prevent patients from accumulating ammonia. These treatments do not address the underlying cause of disease. In Europe and the U.S., approximately 10,000 people have OTC deficiency. About ARCT-810: ARCT-810 is an intravenously administered investigational mRNA therapeutic designed to express normal functional OTC enzyme in the liver of individuals with OTC deficiency. ARCT-810 has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA), including an approved pediatric investigation plan (PIP), and Orphan Drug Designation along with Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA) for the treatment of ornithine transcarbamylase deficiency. OTC is a key enzyme in the urea cycle which converts toxic ammonia into urea. Elevated ammonia can lead to metabolic crises with progressive and irreversible neurocognitive damage. A safe and effective mRNA therapeutic may restore normal functional OTC enzyme in the liver which could eliminate the risk of future metabolic crises. ARCT-810 is based on Arcturus’ mRNA design construct and proprietary manufacturing process. ARCT-810 also utilizes Arcturus’ extensive and propriety lipid library and employs the Company's LUNAR® delivery platform to deliver OTC mRNA to hepatocytes.
Seeking Alpha • Nov 14Arcturus: LUNAR-CF For CF Presses On With 1st Half Of 2025 Interim DataSummary Interim results from phase 2 proof-of-concept study, using LUNAR-CF for treatment of patients with Cystic Fibrosis, expected 1st half of 2025. The global Cystic Fibrosis market size is projected to reach $62.57 billion by 2032. Interim results from phase 2 proof-of-concept study, using LUNAR-OTC for treatment of patients with OTC Deficiency, expected 1st half of 2025. CHMP opinion on KOSATIVE for Covid-19 expected December of 2025; Company has earned up to $462.1 million in milestone and upfront payments from CSL as of September 30th 2024. Read the full article on Seeking Alpha
お知らせ • Nov 12Arcturus Therapeutics Holdings Inc. Receives Clearance from FDA to Begin H5N1 Pandemic Flu Vaccine Clinical TrialArcturus Therapeutics Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a "Study Can Proceed" notification for the Company's Investigational New Drug (IND) application, ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus. The clinical study is funded by Biomedical Advanced Research and Development Authority (BARDA) and designed to enroll approximately 200 healthy adults in the United States. ARCT-2304 is a sa-mRNA vaccine candidate formulated within a lipid nanoparticle (LNP). The sa-mRNA vaccine candidate is designed to make many copies of mRNA within the host cell after intramuscular injection to achieve enhanced expression of haemagglutinin (HA) and neuraminidase (NA) antigens, thereby enabling lower doses than conventional mRNA vaccines. Utilizing a mRNA-based platform for pandemic influenza vaccine development offers further options for meeting domestic vaccine manufacturing surge capacity goals. The technology may make vaccines available much sooner than egg- and cell-based technologies. The lyophilized vaccine formulation is stable in refrigerators, thereby simplifying cold-chain storage and reducing distribution risks.
お知らせ • Nov 01Arcturus Therapeutics Holdings Inc. to Report Q3, 2024 Results on Nov 07, 2024Arcturus Therapeutics Holdings Inc. announced that they will report Q3, 2024 results After-Market on Nov 07, 2024
分析記事 • Oct 04Improved Revenues Required Before Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Stock's 28% Jump Looks JustifiedArcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) shareholders would be excited to see that the share price has had a...
お知らせ • Sep 14Japan's Ministry of Health, Labor and Welfare Approves CSL and Arcturus Therapeutics Holdings Inc.'s Updated Self-Amplifying mRNA Covid-19 Vaccine for Protection Against JN.1 StrainCSL and Arcturus Therapeutics Holdings Inc. announced that Japan's Ministry of Health, Labor and Welfare (MHLWs) granted approval and authorization for their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE. The updated vaccine is targeted to protect against the JN.1 lineage of Omicron subvariants for adults 18 years of age and older. CSL's exclusive partner in Japan, Meiji Seika Pharma, will begin distributing the updated vaccine in time for the October COVID-19 vaccination campaign, marking the commercially available sa-mRNA COVID-19 vaccine for adults 18 and older. In May 2024, a Japanese health ministry panel recommended that COVID-19 vaccines be updated to target the JN.1 lineage of Omicron subvariants for the 2024/2025 national immunization program. This aligns with recent recommendations from the World Health Organization. The approval is based on clinical evidence supporting the safety and effectiveness of CSL and Arcturus Therapeutics’ sa-mRNA COVID-19 vaccine, including published data demonstrating superior immunogenicity to Omicron BA 4/5 compared to a conventional mRNA COVID-19 vaccine booster and follow-up data demonstrating duration of immunity lasting up to one year.
分析記事 • Sep 06Here's Why We're Not Too Worried About Arcturus Therapeutics Holdings' (NASDAQ:ARCT) Cash Burn SituationJust because a business does not make any money, does not mean that the stock will go down. For example, although...
お知らせ • Sep 03Arcturus Therapeutics Holdings Inc. Receives Clearance of an Investigational New Drug Application to U.S. Food and Drug Administration for ARCT-032, an Investigational Inhaled mRNA Therapeutic to Treat Cystic FibrosisArcturus Therapeutics Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a "Study May Proceed" notification for the Company's Investigational New Drug (IND) application, ARCT-032, to treat cystic fibrosis (CF). FDA clearance of the ARCT-032 IND application enables the Company to initiate a Phase 2 multiple ascending dose study to evaluate the safety, tolerability and efficacy of ARCT-032 in people with Cystic Fibrosis. Cystic fibrosis is a life-shortening disease with a worldwide prevalence. Mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene result in a reduction or absence of CFTR protein and/or function in the airways, causing insufficient chloride transport to maintain airway surface homeostasis. CF mucus is more difficult to clear, thus clogging the airways and leading to infection, inflammation, respiratory failure, or other life-threatening complications. Standard of care for many CF individuals include CFTR modulators. Nearly 40,000 people in the U.S. and more than 105,000 people worldwide are living with CF. Approximately 15% of individuals with CF do not benefit from CFTR modulator medicines due to dysfunctional or absent CFTR protein and/or drug intolerance. ARCT-032 is an inhaled investigational mRNA therapeutic designed to express normal functional CFTR in the lungs of individuals with CF. ARCT-032 has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) and Orphan Drug Designation along with Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA) to treat cystic fibrosis. ARCT-032 utilizes Arcturus' LUNAR lipid-mediated aerosolized platform to deliver CFTR messenger RNA to the lungs. Lung disease is the leading cause of morbidity and mortality in people with CF. Expression of a functional copy of the CFTR mRNA in the lungs of people with CF has the potential to restore CFTR activity and mitigate the downstream effects that cause progressive lung disease. The ARCT-032 program is supported by preclinical data in rodents, ferrets and primates, as well as demonstrating restoration of CFTR expression and function in human bronchial epithelial cells.
Seeking Alpha • Aug 09High-Risk, High-Reward: Arcturus Nears Commercialization Of Kostaive VaccineSummary Arcturus is close to launching the Kostaive COVID-19 vaccine in Japan, with ongoing work on variant protection and influenza vaccine. The company has been able to consistently derive research revenues, maintaining liquidity and avoiding debt, with potential for significant revenue from vaccine orders. Valuation suggests Arcturus may be undervalued compared to peers, with a revised model showing potential for significant revenue growth by 2026. Read the full article on Seeking Alpha
お知らせ • Jul 19Arcturus Therapeutics Holdings Inc. to Report Q2, 2024 Results on Aug 05, 2024Arcturus Therapeutics Holdings Inc. announced that they will report Q2, 2024 results After-Market on Aug 05, 2024
お知らせ • Jul 02Arcturus Therapeutics Holdings Inc. Provides Updates for Ornithine Transcarbamylase (OTC) Deficiency and Cystic Fibrosis (CF) ProgramsArcturus Therapeutics Holdings Inc. announced it is providing mid-year updates for ARCT-810, an investigational mRNA therapeutic to treat ornithine transcarbamylase (OTC) deficiency, and ARCT-032, an investigational inhaled mRNA therapeutic to treat cystic fibrosis (CF). ARCT-810 (OTC Deficiency) Update: The double blind ARCT-810 Phase 2 study in the EU and UK has completed enrollment of eight (8) subjects, including adolescents and adults, at the 0.3 mg/kg dose level. The participants in this group are randomized 3:1 and receive 6 doses of ARCT-810 or placebo administered every 14 days. Treatment and follow-up are ongoing with the safety and complete set of biomarker data expected later this year. ARCT-810 is expanding the Company’s clinical program in the U.S. by enrolling patients with more severe disease. Patient screening has been initiated and the Company expects the Phase 2 clinical program to be completed in the United States. More details pertaining to the U.S. trial expansion and interim data will be provided later this year. ARCT-032 (CF) Update: The Company plans to submit an IND application in the next 60 days for an ARCT-032 Phase 2 multiple ascending dose study designed to identify a safe and effective dose in Class I (null) and other CF participants who do not benefit from CFTR modulators. This study is supported by safety and tolerability data collected in healthy volunteers (N = 32) and the ongoing two-administration Phase 1b study. No serious adverse events (SAEs) have been observed in any clinical trial participants to date. No febrile reactions have been observed within the target dose range of the planned Phase 2 study. The Phase 1b study is ongoing with the seventh and final participant scheduled to be dosed soon. Of the seven total CF participants in Phase 1b, six are receiving CFTR modulator treatment while one subject has Class I mutations and therefore does not benefit from modulator therapy. The Class I CF subject had low lung function at baseline (ppFEV1 below 50%) and showed an improvement of 4% in ppFEV1 on Day 8, after receiving two well-tolerated administrations, with no febrile reactions.
お知らせ • Jun 20Arcturus Therapeutics Holdings Inc. Appoints Moncef Slaoui, Ph.D., to Board of DirectorsArcturus Therapeutics Holdings Inc. announced the appointment of a new independent director, Moncef Slaoui, Ph.D., to the Company's Board of Directors. Dr. Moncef Slaoui was most recently the Chief Scientific Advisor to Operation Warp Speed. Under his leadership the operation enabled the fastest ever development, manufacturing, and approval of multiple COVID-19 vaccines in less than 11 months after the virus genetic sequence was described. Dr. Slaoui has sat on several biotechnology company boards, including Moderna Inc. and Lonza Group AG, and he chaired the boards of Galvani, and Vaxcyte, a vaccine development platform company. Dr. Slaoui spent nearly 30 years at GlaxoSmithKline (GSK) holding leadership positions including as member of the Board of Directors of GSK PLC; Chairman of Pharmaceutical R&D; Chairman Global R&D, Vaccines & Oncology; and Chairman, Global Vaccines. As Chairman of Pharmaceutical R&D, Dr. Slaoui led a restructuring to improve focus on innovation and productivity. As Chairman of Global Vaccines, Dr. Slaoui was directly involved in GSK's vaccine pipeline, leading to the creation of 14 new vaccines, including Shingrix®, to prevent shingles; Cervarix®, to prevent cervical cancer; Mosquirix, to prevent malaria; Rotarix®, to prevent rotavirus gastroenteritis; and Synflorix, to prevent pneumococcal disease. In 2016, Dr. Slaoui was recognized as one of Fortune's 50 Greatest World Leaders for his work in under-researched diseases common in the developing world, served on the Advisory Committee to the Director of the NIH from 2011 to 2016, and has advised the U.S. President's Council of Advisors on Science and Technology. Dr. Slaoui holds a Ph.D. in Molecular Biology and Immunology from the Université Libre de Bruxelles, completed postdoctoral studies at Harvard Medical School and Tufts University School of Medicine, and was a Professor of Immunology at the University of Mons, Belgium. He received an accelerated Master of Business Administration from IMD, Switzerland in 1998.
Seeking Alpha • Jun 08Arcturus: A Hidden Gem In The Biotech SectorSummary Arcturus is a top pick in the biotech sector with a strong stock market performance. The company generates revenue from research and development partnerships, which helps conserve cash. The launch of the Kostaive vaccine and other programs are expected to drive revenue growth in the short and long term. Read the full article on Seeking Alpha
お知らせ • May 29Arcturus Therapeutics Holdings Inc. Announces Positive Development for Cystic Fibrosis ProgramArcturus Therapeutics Holdings Inc. announced ARCT-032 will be presenting Phase 1 results in healthy volunteers and new Phase 1b interim data in CF patients for ARCT-032, an inhaled investigational mRNA therapeutic to treat CF, at the 47thEuropean Cystic Fibrosis Conference on June 7, 2024. Arcturus will be presented Phase 1 results in healthy volunteers. ARCT-032 has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) to treat Cystic Fibrosis. ARCT-032 utilizes Arcturus' LUNAR lipid-mediated aerosolized platform to deliver CFTR messenger RNA to the lungs. The ARCT-032 program is supported by preclinical data in rodents, ferrets and primates, as well as demonstrating restoration of CFTR expression and function in human bronchial epithelial cells.
分析記事 • May 29Arcturus Therapeutics Holdings Inc.'s (NASDAQ:ARCT) Share Price Boosted 45% But Its Business Prospects Need A Lift TooArcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) shareholders are no doubt pleased to see that the share price has...
New Risk • May 28New 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. This is currently the only risk that has been identified for the company.
お知らせ • May 23Nature Communications Publishes Pivotal Data Demonstrating Efficacy and Tolerability of CSL and Arcturus Therapeutics' COVID-19 VaccineCSL and Arcturus Therapeutics announced Nature Communications has published results from an integrated phase 1/2/3a/3b study evaluating the safety, immunogenicity, and efficacy of ARCT, 154, a novel self-amplifying (sa-mRNA) COVID-19 vaccine and the world's first approved sa-mRNA COVID-19 vaccine. The results demonstrate that two 5 mg doses of ARCT-154, sa-mRNA vaccine, were well-tolerated, immunogenic and provided significant protection against multiple strains of COVID-19. The efficacy of ARCT-154 against severe COVID-19 was 100% in healthy persons aged 18-59 and more than 90% in persons at risk of severe consequences of the disease due to co-morbidities or older age. During the observer-blind, randomized, controlled phase 1, 2, 3a and 3b integrated study, adults =18 years old receive two 5 µg doses of ARCT-154 or saline placebo 28 days apart. Phase 2/3a/3b participants were stratified by age (< 60 or = 60 years of age) and by risk of severe COVID-19 prior to being randomized 3:1 (phase 1/2/3a) or 1:1 (phase 3b) to vaccine or placebo groups. The primary endpoints were vaccine efficacy up to 2 months after dose 2, reactogenicity within up to 7 days of each dose, safety within up to 28 days after each dose, and immunogenicity measured 28 days after each dose From August 15 to January 12, 2023, 1,001 participants were randomized (748 ARCT-154 and 253 placebo) in the integrated phase 1/2/3a study, and 16,100 participants (8,056 ARCT-154 and 8,044 placebo) in the phase 3b study. In the phase 1/2/3a studies, ARCT-154 was safe and well tolerated. Most solicited adverse events were mild or moderate and resolved quickly, and rates of related or severe unsolicited adverse events were similar in the ARCT-154 and placebo groups. The phase 3b study confirmed these observations. Four weeks after the second ARCT-154 dose in phase 3b, the neutralizing antibody seroconversion rate was 94.1% (95% CI: 92•1–95•8). There were 640 confirmed, protocol-defined COVID-19 cases, mainly of the Delta variant, that were determined to be eligible for analysis, including 43 severe cases and 10 deaths attributed to COVID-19. ARCT-154 absolute efficacy was 56.6% (95% CI: 48.7– 63.3) against any COVID-19, 95•3% (80.5–98.9) against severe COVID-19 and 86.5% (-7.4–98.3) against death due to COVID-19. Efficacy against severe COVID-19 was 100% in healthy 18-59-year-olds and 91.9% (37.9-98.9) in participants in that age group with underlying co-morbidities, which put them at risk for severe disease. In adults aged 60 years or older, efficacy was 54.3% (28.2–70.9) against COVID-19 of any severity and 94.4% (58.2–99.3) against severe COVID-19.
Major Estimate Revision • May 15Consensus revenue estimates increase by 24%, EPS downgradedThe consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$147.0m to US$181.8m. EPS estimate fell from -US$2.61 to -US$2.99 per share. Biotechs industry in the US expected to see average net income decline 9.7% next year. Consensus price target up from US$67.93 to US$72.29. Share price rose 6.6% to US$29.02 over the past week.
Reported Earnings • May 09First quarter 2024 earnings: EPS and revenues exceed analyst expectationsFirst quarter 2024 results: US$1.00 loss per share (down from US$1.91 profit in 1Q 2023). Revenue: US$38.0m (down 53% from 1Q 2023). Net loss: US$26.8m (down 153% from profit in 1Q 2023). Revenue exceeded analyst estimates by 115%. Earnings per share (EPS) also surpassed analyst estimates by 19%. Revenue is forecast to grow 41% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 64% per year but the company’s share price has only increased by 2% per year, which means it is significantly lagging earnings growth.
お知らせ • May 01Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 14, 2024Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 14, 2024, at 09:00 Pacific Standard Time. Agenda: To elect Dr. Peter Farrell, Joseph E. Payne, Andy Sassine, James Barlow, Dr. Edward W. Holmes, Dr. Magda Marquet, Dr. Jing L. Marantz, and Dr. John Markels to the Board of Directors (the “Board”), to serve until our next annual meeting of stockholders; to approve an amendment to the Amended and Restated 2019 Omnibus Equity Incentive Plan (as amended, the “Plan”) to, among other things, increase the maximum number of shares of common stock available to Plan participants thereunder by 2,000,000 shares to an aggregate of 10,750,000 shares; to approve, on a non-binding advisory basis, the resolution approving named executive officer compensation; to ratify the appointment of Deloitte & Touche LLP (“Deloitte”), as an independent registered public accounting firm for the fiscal year ending December 31, 2024; and to transact other business that may properly come before the annual meeting.
お知らせ • Apr 28Arcturus Therapeutics Holdings Inc. to Report Q1, 2024 Results on May 08, 2024Arcturus Therapeutics Holdings Inc. announced that they will report Q1, 2024 results After-Market on May 08, 2024
Seeking Alpha • Apr 23Arcturus Therapeutics' ARCT-032: Might Be The Next Breakthrough In Cystic FibrosisSummary Arcturus Therapeutics' ARCT-032 gene therapy for cystic fibrosis has been designated as an "orphan drug" in the U.S. and Europe. The therapy has the potential to generate significant revenues, similar to Vertex Pharmaceuticals' Trikafta treatment. ARCT's financial status is currently unstable, but the company has the potential to become profitable with the success of ARCT-032 and other therapies. Read the full article on Seeking Alpha
分析記事 • Apr 09Arcturus Therapeutics Holdings (NASDAQ:ARCT) Is In A Strong Position To Grow Its BusinessJust because a business does not make any money, does not mean that the stock will go down. For example, although...
Major Estimate Revision • Mar 24Consensus EPS estimates fall by 20%The consensus outlook for earnings per share (EPS) in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$166.7m to US$150.8m. Losses expected to increase from US$2.05 per share to US$2.46. Biotechs industry in the US expected to see average net income decline 9.2% next year. Consensus price target of US$67.89 unchanged from last update. Share price fell 6.6% to US$33.90 over the past week.
Recent Insider Transactions Derivative • Mar 21Founder notifies of intention to sell stockPadmanabh Chivukula intends to sell 26k shares in the next 90 days after lodging an Intent To Sell Form on the 19th of March. If the sale is conducted around the recent share price of US$35.00, it would amount to US$910k. Since June 2023, Padmanabh's direct individual holding has decreased from 549.45k shares to 499.45k. Company insiders have collectively sold US$315k more than they bought, via options and on-market transactions in the last 12 months.
Major Estimate Revision • Mar 14Consensus EPS estimates upgraded to US$2.19 lossThe consensus outlook for fiscal year 2024 has been updated. 2024 losses forecast to reduce from -US$3.33 to -US$2.19 per share. Revenue forecast steady at US$163.2m. Biotechs industry in the US expected to see average net income decline 8.3% next year. Consensus price target up from US$66.33 to US$67.89. Share price was steady at US$37.90 over the past week.
Reported Earnings • Mar 09Full year 2023 earnings: EPS exceeds analyst expectations while revenues lag behindFull year 2023 results: US$1.00 loss per share (down from US$0.35 profit in FY 2022). Revenue: US$169.9m (down 18% from FY 2022). Net loss: US$26.6m (down 384% from profit in FY 2022). Revenue missed analyst estimates by 2.2%. Earnings per share (EPS) exceeded analyst estimates by 35%. Revenue is forecast to grow 35% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 70% per year but the company’s share price has fallen by 9% per year, which means it is significantly lagging earnings.
Valuation Update With 7 Day Price Move • Feb 28Investor sentiment improves as stock rises 22%After last week's 22% share price gain to US$42.99, the stock trades at a trailing P/E ratio of 11.6x. Average trailing P/E is 14x in the Biotechs industry in the US. Total loss to shareholders of 15% over the past three years.
お知らせ • Feb 21Arcturus Therapeutics Holdings Inc. to Report Q4, 2023 Results on Mar 07, 2024Arcturus Therapeutics Holdings Inc. announced that they will report Q4, 2023 results After-Market on Mar 07, 2024
Price Target Changed • Feb 09Price target increased by 8.0% to US$66.33Up from US$61.44, the current price target is an average from 9 analysts. New target price is 75% above last closing price of US$37.91. Stock is up 100% over the past year. The company is forecast to post a net loss per share of US$1.53 compared to earnings per share of US$0.35 last year.
分析記事 • Feb 06Arcturus Therapeutics Holdings Inc.'s (NASDAQ:ARCT) Price Is Right But Growth Is LackingWith a price-to-sales (or "P/S") ratio of 3.2x Arcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) may be sending very...
Seeking Alpha • Jan 31Arcturus: H1 2024 Rare Disease Drug Data On DeckSummary Arcturus Therapeutics Holdings Inc. interim results from the phase 1b study, using ARCT-032 for the treatment of patients with Cystic Fibrosis, are expected in the 1st half of 2024. The global Cystic Fibrosis market is projected to grow to $12.9 billion by 2030. Interim results from the phase 2 study, using ARCT-810 for the treatment of patients with OTC Deficiency, are expected in the 1st half of 2024. Received approval with partner CSL in Japan for ARCT-154 as the first self-amplifying mRNA vaccine for adults with COVID-19. Read the full article on Seeking Alpha
分析記事 • Jan 11Does Arcturus Therapeutics Holdings (NASDAQ:ARCT) Have A Healthy Balance Sheet?Howard Marks put it nicely when he said that, rather than worrying about share price volatility, 'The possibility of...
お知らせ • Dec 21CSL and Arcturus Therapeutics' ARCT-154 Demonstrates Non-Inferiority to Original Strain and Superior Immunogenicity to Omicronba BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster BoosterCSL and Arcturus Therapeutics announced the publication in Lancet Infectious Diseases of a Phase 3 study showing that a booster dose of ARCT-154, a novel, self-amplifying messenger RNA (sa-mRNA) vaccine, expedited a numerically higher immune response (meeting the non-inferiority criteria) against the original Wuhan-Hu-1 virus strain, and a superior immune response against Omicron BA.4/5 subvariant of SARS-CoV-2 virus compared to a booster dose of the conventional mRNA vaccine Comirnaty. The study included healthy adults initially immunized with two doses of an mRNA vaccine (Comirnaty or Spikevax); and then a third dose of Comirnaty at least three months prior to the booster dose of either ARCT-154 or Comirnaty in the study. Both vaccines were well-tolerated, with no causally associated severe or serious adverse events. The study was conducted in partnership with Meiji Seika Pharma, a global health company based in Japan. The phase 3 study results with ARCT-154 were used to support the approval of ARCT-154 for primary immunization and as a booster dose in Japan in November of this year. The ARCT-154 study is ongoing and will continue to collect safety data and assess durability of the immune response in participants at 3-, 6- and 12-months post-vaccination. The randomized, double-blind, active-controlled study, conducted at 11 sites in Japan, was designed to compare the immunogenicity and tolerability of the sa-mRNA vaccine ARCT-154 with authorized mRNA COVID-19 vaccine Comirnaty. Investigators compared immune responses to ARCT-154 and Comirnaty booster doses in healthy Japanese adults 18 years of age or older initially immunized with two dose of mRNA COVID-19 vaccine (Comirnaty or Spikevax) and then a third dose ofComirnaty at least three months prior to receiving a booster dose of one of the study vaccines.
Valuation Update With 7 Day Price Move • Dec 20Investor sentiment improves as stock rises 25%After last week's 25% share price gain to US$32.41, the stock trades at a trailing P/E ratio of 8.7x. Average forward P/E is 18x in the Biotechs industry in the US. Total loss to shareholders of 68% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at US$47.95 per share.
分析記事 • Dec 14Are Investors Undervaluing Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) By 46%?Key Insights Arcturus Therapeutics Holdings' estimated fair value is US$47.95 based on 2 Stage Free Cash Flow to Equity...
お知らせ • Nov 29Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics' ARCT-154, the First Self-Amplifying mRNA Vaccine Approves for COVID in AdultsCSL and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval forARCT-154, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older. The approval is based on positive clinical data from several ARCT-154 studies, including an ongoing 16,000 subject efficacy study performed in Vietnam as well as a Phase 3 COVID-19 booster trial, which achieved higher immunogenicity results and a favorable safety profile compared to a standard mRNA COVID-19 vaccine comparison. Initial study results have been published in MedRxiv and are expected to be published in a peer-reviewed journal by the end of the year. CSL's vaccine business, CSL Seqirus, one of the largest influenza vaccine providers in the world, partnered exclusively with Meiji Seika Pharma for distribution of the sa-mRNA COVID vaccine, ARCT 154, in Japan.
Major Estimate Revision • Nov 22Consensus revenue estimates increase by 27%The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$136.7m to US$174.0m. Forecast losses expected to reduce from -US$2.84 to -US$1.54 per share. Biotechs industry in the US expected to see average net income growth of 10% next year. Consensus price target broadly unchanged at US$61.44. Share price was steady at US$22.94 over the past week.
Reported Earnings • Nov 16Third quarter 2023 earnings: EPS and revenues exceed analyst expectationsThird quarter 2023 results: US$0.61 loss per share (improved from US$1.33 loss in 3Q 2022). Revenue: US$45.1m (up 238% from 3Q 2022). Net loss: US$16.2m (loss narrowed 54% from 3Q 2022). Revenue exceeded analyst estimates by 185%. Earnings per share (EPS) also surpassed analyst estimates by 63%. Revenue is expected to decline by 1.4% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 15%. Over the last 3 years on average, earnings per share has increased by 61% per year but the company’s share price has fallen by 26% per year, which means it is significantly lagging earnings.
お知らせ • Oct 26Arcturus Therapeutics Holdings Inc. to Report Q3, 2023 Results on Nov 14, 2023Arcturus Therapeutics Holdings Inc. announced that they will report Q3, 2023 results After-Market on Nov 14, 2023
Recent Insider Transactions Derivative • Oct 04Founder notifies of intention to sell stockPadmanabh Chivukula intends to sell 15k shares in the next 90 days after lodging an Intent To Sell Form on the 2nd of October. If the sale is conducted around the recent share price of US$26.00, it would amount to US$390k. Since March 2023, Padmanabh's direct individual holding has decreased from 589.45k shares to 509.45k. Company insiders have collectively sold US$233k more than they bought, via options and on-market transactions in the last 12 months.
お知らせ • Sep 27+ 1 more updateArcturus Therapeutics Holdings Inc. announced that it has received $25 million in funding from Cystic Fibrosis FoundationArcturus Therapeutics Holdings Inc. announced that it has raised up to $9 million in a round of funding on September 26, 2023. The transaction will include participation from returning investor, Cystic Fibrosis Foundation. On the same day, the company amended the terms of the transaction and it raised up to $25 million.
分析記事 • Sep 14Arcturus Therapeutics Holdings Inc.'s (NASDAQ:ARCT) Shares Lagging The Industry But So Is The BusinessArcturus Therapeutics Holdings Inc.'s ( NASDAQ:ARCT ) price-to-sales (or "P/S") ratio of 2.9x might make it look like a...
お知らせ • Sep 06Arcturus Therapeutics Holdings Inc. and Csl Seqirus Announce European Medicines Agency Validates Marketing Authorization Application for Arct-154 Vaccine to Prevent Covid-19Arcturus Therapeutics Holdings Inc. and CSL announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for ARCT-154, a next generation mRNA vaccine, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The companies (Arcturus and CSL Seqirus) anticipate an approval decision by the European Commission in 2024. The EMA submission is based on successful Phase 3 clinical results of ARCT-154 against the ancestral D614G variant as a primary series and booster. In an analysis of 6-month data from the pivotal Phase 3 study, the primary efficacy endpoint was met and ARCT-154 as a primary series resulted in 56.6% efficacy for prevention of symptomatic COVID-19 overall, and 95.3% efficacy for prevention of severe COVID-19 including COVID-19 related deaths. The study was conducted when Delta variant was dominant in Vietnam. The booster data result was previously announced by CSL Seqirus' partner, Meiji Seika Pharma, indicating that the primary endpoint was achieved in a Phase 3 booster vaccine study by demonstrating non-inferiority of immune response against SARS-CoV- 2 ancestral strain compared to Comirnaty®?. Superiority of ARCT-154 in neutralizing antibody response against SARS- CoV-2 Omicron BA.4/5 variant was a key secondary endpoint. The unique combination of commercial strength, R&D focus and operational excellence enables to identify, develop and deliver innovations so patients can live life to the fullest.
Recent Insider Transactions Derivative • Sep 03Founder notifies of intention to sell stockPadmanabh Chivukula intends to sell 5k shares in the next 90 days after lodging an Intent To Sell Form on the 1st of September. If the sale is conducted around the recent share price of US$31.00, it would amount to US$155k. Since March 2023, Padmanabh's direct individual holding has decreased from 589.45k shares to 514.45k. Company insiders have collectively sold US$233k more than they bought, via options and on-market transactions in the last 12 months.
Valuation Update With 7 Day Price Move • Aug 15Investor sentiment improves as stock rises 16%After last week's 16% share price gain to US$29.94, the stock trades at a trailing P/E ratio of 9.9x. Average forward P/E is 12x in the Biotechs industry in the US. Total loss to shareholders of 47% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at US$48.37 per share.
Major Estimate Revision • Aug 14Consensus revenue estimates fall by 17%The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$174.9m to US$145.5m. Forecast losses increased from -US$0.697 to -US$2.16 per share. Biotechs industry in the US expected to see average net income decline 13% next year. Consensus price target of US$60.44 unchanged from last update. Share price fell 13% to US$27.77 over the past week.
New Risk • Aug 09New 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: Minor Risks Share price has been volatile over the past 3 months (10% average weekly change). Large one-off items impacting financial results.
Reported Earnings • Aug 08Second quarter 2023 earnings: EPS and revenues miss analyst expectationsSecond quarter 2023 results: US$1.98 loss per share (further deteriorated from US$0.82 loss in 2Q 2022). Revenue: US$10.5m (down 61% from 2Q 2022). Net loss: US$52.6m (loss widened 144% from 2Q 2022). Revenue missed analyst estimates by 79%. Earnings per share (EPS) also missed analyst estimates significantly. Revenue is forecast to grow 35% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 38% per year but the company’s share price has fallen by 19% per year, which means it is significantly lagging earnings.
Buying Opportunity • Aug 08Now 32% undervalued after recent price dropOver the last 90 days, the stock is down 13%. The fair value is estimated to be US$37.63, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 119% over the last 3 years. Meanwhile, the company has become profitable. For the next 3 years, revenue is forecast to grow by 35% per annum. Earnings is also forecast to grow by 48% per annum over the same time period.
分析記事 • Aug 08Some Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Analysts Just Made A Major Cut To Next Year's EstimatesToday is shaping up negative for Arcturus Therapeutics Holdings Inc. ( NASDAQ:ARCT ) shareholders, with the analysts...
Recent Insider Transactions Derivative • Aug 03Founder notifies of intention to sell stockPadmanabh Chivukula intends to sell 5k shares in the next 90 days after lodging an Intent To Sell Form on the 1st of August. If the sale is conducted around the recent share price of US$35.00, it would amount to US$175k. Since March 2023, Padmanabh's direct individual holding has decreased from 589.45k shares to 519.45k. Company insiders have collectively sold US$233k more than they bought, via options and on-market transactions in the last 12 months.
お知らせ • Jul 25Arcturus Therapeutics Holdings Inc. to Report Q2, 2023 Results on Aug 07, 2023Arcturus Therapeutics Holdings Inc. announced that they will report Q2, 2023 results After-Market on Aug 07, 2023
分析記事 • Jul 19Calculating The Fair Value Of Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT)Key Insights Using the 2 Stage Free Cash Flow to Equity, Arcturus Therapeutics Holdings fair value estimate is US$33.33...
Recent Insider Transactions Derivative • Jul 17Founder notifies of intention to sell stockPadmanabh Chivukula intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 14th of July. If the sale is conducted around the recent share price of US$30.81, it would amount to US$770k. Since March 2023, Padmanabh's direct individual holding has decreased from 589.45k shares to 544.45k. Company insiders have collectively sold US$51k more than they bought, via options and on-market transactions in the last 12 months.
