Annuncio • Jun 13
Kyntra Bio Presents New Roxadustat Data on Improvements in Transfusion Independence in Patients with Anemia Due to Lower-Risk Myelodysplastic Syndromes Kyntra Bio announced additional data from the Phase 3 MATTERHORN trial showing improvements in transfusion independence in patients with anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) treated with roxadustat will be presented as a poster at the European Hematology Association (EHA) Congress 2026, taking place June 11-14, 2026 in Stockholm, Sweden. In a post hoc analysis, patients treated with roxadustat showed a durable and clinically meaningful improvement in transfusion independence (TI) in patients with LR-MDS and high transfusion burden (HTB) compared to placebo. Similar rates of TI for patients treated with roxadustat were observed in both ring sideroblast positive (RS+) and ring sideroblast negative (RS-) disease. Pivotal Phase 3 trial protocol of roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden is being finalized based on feedback received from the Food and Drug Administration (FDA). As previously disclosed, the initial analysis with all of the patients who participated in the Phase 3 MATTERHORN trial showed that more patients receiving roxadustat achieved transfusion independence vs. placebo (48% vs. 33%; p=0.22). The presentation highlights data from a post hoc analysis of the entire trial population, demonstrating that roxadustat led to similar rates of transfusion independence in both RS+ and RS- patients. In RS- patients, which comprised 84 of the 140 patients enrolled in the trial, treatment with roxadustat led to transfusion independence for =8 weeks over 28 weeks in 48% of patients vs. 28% for placebo. The presentation at EHA also provides additional details on the subgroup of patients (n=37) who met the criteria of HTB (= 4 units pRBCs per 8-week period for 2 consecutive 8-week periods) per IWG-2018, where roxadustat achieved clinically meaningful efficacy in patients with LR-MDS and HTB with higher rates of =8-, 12-, 16-week RBC TI vs placebo. TEAEs were generally lower grade and managed medically with no new safety signals. The poster presentation, titled “Roxadustat improves transfusion independence in LR-MDS patients with anemia and high transfusion burden and in ring sideroblast positive and negative disease: post-hoc analysis of MATTERHORN study” is scheduled for the poster session taking place on June 12, 2026 at 18:45 CEST. The pivotal Phase 3 trial protocol of roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden is being finalized based on feedback received from the FDA. Roxadustat (also known as FG-4592, EVRENZO™) is currently approved in Europe, Japan, China, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate the development plan for the Phase 3 trial of roxadustat in anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46, is in Phase 2 development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. Annuncio • May 05
Kyntra Bio, Inc. to Report Q1, 2026 Results on May 11, 2026 Kyntra Bio, Inc. announced that they will report Q1, 2026 results After-Market on May 11, 2026 Annuncio • Apr 28
Kyntra Bio, Inc., Annual General Meeting, Jun 12, 2026 Kyntra Bio, Inc., Annual General Meeting, Jun 12, 2026. Annuncio • Apr 11
Kyntra Bio, Inc. Receives Nasdaq Notice Of Non-Compliance With Continued Listing Requirements On April 2, 2026, Kyntra Bio, Inc. (Kyntra Bio or the Company) received a letter from the Nasdaq Listing Qualifications Staff of the Nasdaq Stock Market notifying us that the Company no longer complies with the Nasdaq Global Select Market continued listing requirement of $50 million in total assets and total revenue for the most recently completed fiscal year (or two of the last three most recently completed fiscal years) per Listing Rule 5450(b)(3)(A). This is due to the revenue of FibroGen International being presented as held for sale (in discontinued operations) in 2024 and 2025. The Company does not currently meet the alternative requirements of Listing Rule 5450(b) (either the shareholders' equity or the market value of listed securities standards). The notification received has no immediate effect on the listing of Kyntra Bio's common stock on Nasdaq. Under the Nasdaq Rules, the Company has 45 days (May 18, 2026) to submit a plan to regain compliance and if such plan is accepted, Nasdaq may grant the Company with an extension of up to 180 days (September 29, 2026) to evidence compliance. Per Listing Rule 5810(c)(2)(D), the Company may submit a plan that demonstrates current or near term compliance with the listing requirements relating to stockholders' equity or market value of listed securities. In determining whether to accept our plan, Nasdaq will consider such things as the likelihood that the plan will result in compliance with Nasdaq's continued listing criteria, the Company's past compliance history, the reasons for the Company's current non-compliance, other corporate events that may occur within the review period, the Company's overall financial condition, and its public disclosures. Kyntra Bio may also consider applying to transfer the Company's securities to the Nasdaq Capital Market. Reported Earnings • Mar 19
Full year 2025 earnings released: US$14.40 loss per share (vs US$38.26 loss in FY 2024) Full year 2025 results: US$14.40 loss per share (improved from US$38.26 loss in FY 2024). Net loss: US$58.2m (loss narrowed 62% from FY 2024). Revenue is expected to decline by 7.1% p.a. on average during the next 3 years, while revenues in the Global Biotechs industry are expected to grow by 19%. Annuncio • Mar 09
Kyntra Bio, Inc. to Report Q4, 2025 Results on Mar 16, 2026 Kyntra Bio, Inc. announced that they will report Q4, 2025 results After-Market on Mar 16, 2026 Annuncio • Feb 24
Kyntra Bio Announces Positive Data from the Investigator-Sponsored Phase 1B/2 Study of Fg-3246 Kyntra Bio announced that the data on anti-tumor activity of FG-3246 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) from the investigator-sponsored Phase 1b/2 study will be presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), taking place February 26-28, 2026 in San Francisco, CA. The presentation includes data from 44 biomarker unselected patients with progressive metastatic castration-resistant prostate cancer, 17 of which were enrolled in the Phase 1b dose escalation portion of the study. Eligibility criteria for the trial included patients who progressed on at least one prior ARPI while patients who were treated with prior chemotherapy in the castration-resistant setting were excluded. Over 60% of the patients progressed on two or more prior ARPIs, which included prior enzalutamide treatment. The primary endpoint of the escalation phase was assessment of dose-limiting toxicities (DLT) and determination of the maximum tolerated dose and recommended dose for the Phase 2 portion of the study – which was determined to be 2.1 mg/kg of FG-3246 and 160 mg/day of enzalutamide. The primary endpoint of the Phase 2 expansion portion of the study was composite response rate (PSA50 response and/or objective response per RECIST v1.1). Secondary endpoints were PSA50 response rate, objective response rate, radiographic progression free survival (rPFS), overall survival, and treatment-related adverse events (TRAEs). FG-3246 combined with enzalutamide demonstrated anti-tumor activity with a composite response rate of 21% in the overall cohort and 40% in patients who had progressed on only one prior ARPI. Median rPFS of 7.0 months was observed in the overall cohort. Notably, median rPFS of 10.1 months was observed in patients who had progressed on only one prior ARPI, a result which was consistent across the different prior ARPIs administered. Additionally, higher tumor uptake of FG-3180 demonstrated a trend towards higher probability of PSA50 response (p=0.053), highlighting the potential of FG-3180 as a biomarker for patient selection. Combination therapy of FG-3246 and enzalutamide demonstrated a similar safety profile as was observed in the previous Phase 1 monotherapy trial of FG-3246. Neutropenia risk was successfully mitigated with use of G-CSF prophylaxis. The most frequent TRAEs with the combination therapy included fatigue, peripheral neuropathy, anorexia, and dysgeusia. Cumulative toxicities, including peripheral neuropathy, led to treatment discontinuation for some patients. FG-3246 is currently being evaluated in a Phase 2 monotherapy trial with interim data expected in the second half of 2026. The trial also includes treatment with FG-3180, a CD46-directed PET imaging agent, which will measure expression levels of CD46 positive lesions. This will enable further assessment of the correlation between CD46 expression and response to FG-3246 and the potential of FG-3180 to serve as a biomarker to aid in patient selection in future trials of FG-3246. Recent Insider Transactions • Nov 20
CEO & Director recently bought Mex$620k worth of stock On the 17th of November, Thane Wettig bought around 4k shares on-market at roughly Mex$167 per share. This transaction amounted to 22% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Thane has been a buyer over the last 12 months, purchasing a net total of Mex$1.6m worth in shares. Reported Earnings • Nov 13
Third quarter 2025 earnings released: US$3.25 loss per share (vs US$4.25 loss in 3Q 2024) Third quarter 2025 results: US$3.25 loss per share (improved from US$4.25 loss in 3Q 2024). Net loss: US$13.1m (loss narrowed 23% from 3Q 2024). Revenue is expected to decline by 8.5% p.a. on average during the next 3 years, while revenues in the Global Biotechs industry are expected to grow by 21%. Annuncio • Nov 04
FibroGen, Inc. to Report Q3, 2025 Results on Nov 10, 2025 FibroGen, Inc. announced that they will report Q3, 2025 results After-Market on Nov 10, 2025 New Risk • Oct 31
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.2% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$24m free cash flow). Shares are highly illiquid. Negative equity (-US$181m). Earnings are forecast to decline by an average of 0.2% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$58m net loss in 3 years). Market cap is less than US$100m (Mex$827.9m market cap, or US$44.6m). Annuncio • Sep 24
FibroGen, Inc. Initiates Phase 2 Monotherapy Trial of FG-3246, a First-in-Class CD46 Targeting ADC, in Metastatic Castration-Resistant Prostate Cancer FibroGen, Inc. announced the initiation of the Phase 2 monotherapy, dose-optimization trial of FG-3246, a potential first-in-class antibody-drug conjugate (ADC) targeting CD46-expressing cancer lesions in patients with metastatic castration-resistant prostate cancer (mCRPC). The trial will also assess the diagnostic and predictive performance of FG-3180, a companion PET imaging agent, which shares the same CD46-targeted antibody used in FG-3246. The Phase 2 monotherapy trial (NCT06842498) is a randomized, open label, dose optimization trial designed to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246 for the treatment of patients with mCRPC who have progressed following ARSI treatment and who have not received chemotherapy for their mCRPC. Secondary endpoints include radiographic progression free survival (rPFS), prostate-specific antigen (PSA) 50 response, and PSA90 response. An interim analysis is planned once 12 patients enrolled in each of the three dose arms have completed 12 weeks on study or discontinued and is anticipated in the second half of 2026. An exploratory sub-study will evaluate FG-3180, a partner PET imaging agent, as a diagnostic radiopharmaceutical. All patients deemed eligible for participation in the Phase 2 trial will participate in the sub-study evaluating FG-3180 prior to randomization. In addition, topline results from the ongoing investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with mCRPC are expected in the fourth quarter of 2025. Reported Earnings • Aug 14
Second quarter 2025 earnings released: US$3.39 loss per share (vs US$11.79 loss in 2Q 2024) Second quarter 2025 results: US$3.39 loss per share (improved from US$11.79 loss in 2Q 2024). Net loss: US$13.7m (loss narrowed 71% from 2Q 2024). Revenue is expected to decline by 3.5% p.a. on average during the next 3 years, while revenues in the Global Biotechs industry are expected to grow by 19%. Annuncio • Aug 07
FibroGen Announces Positive Type C Meeting with the FDA for Roxadustat in Patients with Anemia Associated with Lower-Risk Myelodysplastic Syndromes FibroGen, Inc. announced positive feedback from its Type C meeting with the FDA, supporting the advancement of roxadustat for the treatment of anemia in patients with LR-MDS and high RBC transfusion burden, based on a post-hoc subgroup analysis from the MATTERHORN Phase 3 trial. FibroGen requested the Type C meeting based on the findings of a post-hoc analysis of data from the MATTERHORN trial of roxadustat in anemia-associated with LR-MDS. In patients with high RBC transfusion burden at baseline (4 units over 8 weeks1), a pronounced treatment effect was observed: 36% (8/22) of patients achieved transfusion independence (TI) for 56 days on roxadustat vs 7% (1/15) of patients on placebo within 28 weeks (nominal p-value of 0.041). The planned Phase 3 trial will assess the safety and efficacy of roxadustat In a randomized, double-blind, placebo-controlled design in approximately 200 patients with LR-MDS. Alignment was reached with the FDA on the patient population (patients requiring 4 pRBC units in two consecutive 8-week periods prior to randomization, who are refractory to, intolerant to, or ineligible for prior erythropoiesis-stimulating agents (ESA) therapy), dose regimen, as well as management of potential thrombotic risk through eligibility and dose modification and discontinuation criteria. As the primary endpoint for the study, the Company is considering either 8-week or 16-week RBC TI. FibroGen plans to submit the full Phase 3 protocol to the FDA in the fourth quarter of 2025. Annuncio • Aug 05
FibroGen, Inc. to Report Q2, 2025 Results on Aug 11, 2025 FibroGen, Inc. announced that they will report Q2, 2025 results After-Market on Aug 11, 2025 New Risk • Jul 15
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.7% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$76m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Negative equity (-US$175m). Earnings are forecast to decline by an average of 0.7% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$78m net loss in 3 years). Market cap is less than US$100m (Mex$584.2m market cap, or US$31.1m). Recent Insider Transactions • Jul 05
Independent Chairman of the Board recently bought Mex$2.3m worth of stock On the 30th of June, James Schoeneck bought around 24k shares on-market at roughly Mex$95.61 per share. This transaction increased James' direct individual holding by 1x at the time of the trade. This was the largest purchase by an insider in the last 3 months. James has been a buyer over the last 12 months, purchasing a net total of Mex$4.4m worth in shares. Annuncio • Jun 10
FibroGen, Inc. Announces the Appointment of Michael Kauffman to Its Board of Directors, Effective June 4, 2025 FibroGen, Inc. announced the appointment of Dr. Michael Kauffman to its Board of Directors effective June 4, 2025. Michael G. Kauffman, M.D., Ph.D. has about 30 years of experience in the life sciences industry, particularly in oncology therapeutic products, including expertise in preclinical research, clinical development, regulatory strategy and global approvals. He currently serves as chief executive officer (CEO), president, and board member of Nereid Therapeutics Inc. and is the Lead Director on the board of Verastem Oncology. In addition to Verastem Oncology and Nereid, he is a board member for FoRx Therapeutics, Kezar Life Sciences, Incendia Therapeutics, and BiVictriX Therapeutics. Previously, Dr Kauffman served as the co-founder and CEO of Karyopharm, where he guided the Company's transition from a discovery stage biotechnology company to a commercial stage organization and the global approvals of XPOVIO®. Prior to joining Karyopharm, Dr Kauffman was CMO of Onyx Pharma, where he led the development of Kyprolis® following the Onyx acquisition of Proteolix Inc., where he served as board member and then CMO. Previously, Dr. Kauffman was President and Chief Executive officer of EPIX Pharmaceuticals, Inc. (previously Predix Pharmaceuticals, Inc.). Before that, he was the leader of the Velcade® development program at Millennium Pharmaceuticals and has also held a number of senior positions at Millennium Predictive Medicine and Biogen. Dr Kauffman received his MD and PhD from Johns Hopkins Medical School, trained in Internal Medicine at Beth Israel (Deaconess) Medical Center and in Rheumatology at Massachusetts General Hospital, and is board certified in Internal Medicine. New Risk • May 20
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$76m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$76m free cash flow). Share price has been highly volatile over the past 3 months (20% average weekly change). Negative equity (-US$175m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$80m net loss in 3 years). Market cap is less than US$100m (Mex$610.7m market cap, or US$31.7m). Reported Earnings • May 14
First quarter 2025 earnings released: US$0.17 loss per share (vs US$0.33 loss in 1Q 2024) First quarter 2025 results: US$0.17 loss per share (improved from US$0.33 loss in 1Q 2024). Net loss: US$16.8m (loss narrowed 49% from 1Q 2024). Revenue is forecast to grow 13% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Global Biotechs industry. Annuncio • May 06
FibroGen, Inc. to Report Q1, 2025 Results on May 12, 2025 FibroGen, Inc. announced that they will report Q1, 2025 results After-Market on May 12, 2025 Annuncio • Apr 19
FibroGen, Inc., Annual General Meeting, Jun 04, 2025 FibroGen, Inc., Annual General Meeting, Jun 04, 2025. Annuncio • Mar 28
Fibrogen, Inc. Announces Publication of Results from Phase 1 Monotherapy Study of Fg-3246 in Patients with Metastatic Castration-Resistant Prostate Cancer in the Journal of Clinical Oncology FibroGen, Inc. announced the peer-reviewed publication titled "A Phase 1, First-in-Human Study of FOR46 (FG-3246), an Immune-Modulating Antibody-Drug Conjugate Targeting CD46, in Patients with Metastatic Castration Resistant Prostate Cancer" in the Journal of Clinical Oncology. The manuscript includes the complete results from the Fortis Therapeutics-sponsored Phase 1 study of FOR46 (now known as FG-3246), a potential first-in-class anti-CD46 antibody drug conjugate (ADC) with an MMAE-containing payload, in patients with metastatic castration-resistant prostate cancer (mCRPC). This is the first clinical trial targeting CD46 in patients with prostate cancer, and the totality of the data highlights the promising potential of FG-3246 anti-cancer activity, especially when considering the unselected, heavily pre-treated patient population in the trial. The trial results provide key insights into the potential clinical impact of targeting CD46 in the treatment of mCRPC and support its further development in this disease space with high unmet need," said Dr. Rahul Aggarwal, Professor of Medicine at the University of California San Francisco, and Principal Investigator of the study. Ocular adverse events were infrequent, which may be a distinguishing feature compared with other MMAE-based ADCs. Efficacy observed in the RECIST-evaluable set of 25 patients: Confirmed objective response rate was 20% with median duration of response of 7.5 months; All objective responses observed at a starting dose of 2.7 mg/kg or higher; Disease control rate was 80% with duration of treatment exceeding 24 weeks in 12 patients (48%) PSA50 response rate of 36% in 39 evaluable patients; Of eight evaluable patients who received docetaxel in the castration-sensitive setting, four (50%) achieved a confirmed PSA50 response; Median radiographic progression-free survival of 8.7 months in all 40 subjects in the efficacy analysis set; Of 15 evaluable baseline tumors, 12 (80%) were positive for CD46 expression by immunohistochemistry; FG-3246 responders were found to have a significantly higher frequency of effector T cells and lower frequency of immunosuppressive myeloid cells. The Company anticipates initiating the Phase 2 monotherapy dose optimization study of FG-3246 in patients with mCRPC by mid-2025. FG-3246 is also being evaluated in combination with enzalutamide in an investigator-sponsored study with topline results from the Phase 2 portion of the study anticipated in 2H 2025. Recent Insider Transactions • Mar 25
Independent Chairman of the Board recently bought Mex$2.1m worth of stock On the 21st of March, James Schoeneck bought around 300k shares on-market at roughly Mex$7.08 per share. This transaction increased James' direct individual holding by 3x at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was James' only on-market trade for the last 12 months. Reported Earnings • Mar 18
Full year 2024 earnings released: US$1.53 loss per share (vs US$3.32 loss in FY 2023) Full year 2024 results: US$1.53 loss per share (improved from US$3.32 loss in FY 2023). Revenue: US$29.6m (down 37% from FY 2023). Net loss: US$153.1m (loss narrowed 53% from FY 2023). Products in clinical trials Phase I: 1 Phase II: 1 Revenue is forecast to grow 36% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Global Biotechs industry. Annuncio • Mar 04
FibroGen, Inc. to Report Q4, 2024 Results on Mar 17, 2025 FibroGen, Inc. announced that they will report Q4, 2024 results After-Market on Mar 17, 2025 Annuncio • Feb 25
FibroGen, Inc. has filed a Follow-on Equity Offering in the amount of $30 million. FibroGen, Inc. has filed a Follow-on Equity Offering in the amount of $30 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Annuncio • Feb 22
FibroGen, Inc. Announces Cessation of Christine L. Chung as Senior Vice President, China Operations FibroGen, Inc. announced that upon the closing of the sale of FibroGen International pursuant to the Share Purchase Agreement, Christine L. Chung, who currently serves as Senior Vice President, China Operations, will cease employment with company. Annuncio • Feb 20
AstraZeneca PLC (LSE:AZN) agreed to acquire Beijing Fibrogen Medical Technology Development Co., Ltd. from FibroGen, Inc. (NasdaqGS:FGEN). AstraZeneca PLC (LSE:AZN) agreed to acquire Beijing Fibrogen Medical Technology Development Co., Ltd. from FibroGen, Inc. (NasdaqGS:FGEN) on February 20, 2025. Under the terms of the agreement, FibroGen will receive an enterprise value of $85 million plus FibroGen net cash held in China at closing, currently estimated to be approximately $75 million, totaling approximately $160 million. The transaction is expected to close by mid-2025, pending customary closing conditions, including regulatory review in China.
BofA Securities, Inc. acted as financial advisor for FibroGen, Inc. Ropes & Gray LLP acted as legal advisor for FibroGen, Inc. Annuncio • Dec 16
FibroGen, Inc. Appoints David DeLucia as Chief Financial Officer FibroGen, Inc. announced the appointment of David DeLucia to Chief Financial Officer (CFO), effective December 16, 2024. The company previously announced that Juan Graham would step down on December 15, 2024. Reporting to Chief Executive Officer Thane Wettig, DeLucia will lead and oversee FibroGen’s global finance organization. He has most recently served as FibroGen’s Vice President, Head of Corporate Financial Planning and Analysis, Investor Relations, and Treasury. Mr. DeLucia has nearly 15 years of financial leadership and experience within the life sciences industry. Prior to joining FibroGen in 2022, he held positions of increasing responsibility at TherapeuticsMD, overseeing Financial Planning and Analysis, Corporate Development, and Investor Relations. Earlier in his career, he was a buy-side investor at JP Morgan Asset Management, covering small and mid-cap healthcare companies. Mr. DeLucia holds the Chartered Financial Analyst® designation and a dual degree of Bachelor of Business Administration in Finance & Accounting and Bachelor of Science in Economics from the University of Michigan - Stephen M. Ross School of Business. Reported Earnings • Nov 15
Third quarter 2024 earnings released: US$0.17 loss per share (vs US$0.65 loss in 3Q 2023) Third quarter 2024 results: US$0.17 loss per share (improved from US$0.65 loss in 3Q 2023). Revenue: US$46.3m (up 15% from 3Q 2023). Net loss: US$17.1m (loss narrowed 73% from 3Q 2023). Revenue is expected to decline by 1.4% p.a. on average during the next 3 years, while revenues in the Global Biotechs industry are expected to grow by 22%. Annuncio • Nov 05
FibroGen, Inc. to Report Q3, 2024 Results on Nov 12, 2024 FibroGen, Inc. announced that they will report Q3, 2024 results After-Market on Nov 12, 2024 Annuncio • Sep 17
FibroGen Receives Nasdaq Notification of Non-Compliance with Minimum Bid Price Requirement On September 12, 2024, FibroGen, Inc. (‘FibroGen’) received a letter from the Nasdaq Listing Qualifications Staff of The Nasdaq Stock Market notifying FibroGen that for 30 consecutive business days the bid price of FibroGen’s common stock had closed below $1.00 per share, the minimum closing bid price required by the continued listing requirements of Nasdaq listing rule 5450(a)(1). The notification received has no immediate effect on the listing of FibroGen’s common stock on Nasdaq. In accordance with listing rule 5810(c)(3)(A), FibroGen has 180 calendar days, or until March 11, 2025, to regain compliance with the minimum bid price rule. To regain compliance, the closing bid price of FibroGen’s common stock must be at least $1.00 per share for a minimum of ten consecutive business days (or such longer period of time as the Nasdaq staff may require in some circumstances, but generally not more than 20 consecutive business days) before March 11, 2025. If FibroGen’s common stock does not achieve compliance by March 11, 2025, FibroGen may be eligible for an additional 180-day period to regain compliance if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards, with the exception of the bid price requirement, and provides written notice to Nasdaq of its intention to cure the deficiency during the second compliance period, including by effecting a reverse stock split, if necessary. However, if it appears to the Nasdaq staff that FibroGen will not be able to cure the deficiency, or if FibroGen does not meet the other listing standards, Nasdaq could provide notice that FibroGen’s common stock will become subject to delisting. In the event FibroGen receives notice that its common stock is being delisted, Nasdaq rules permit FibroGen to appeal any delisting determination by the Nasdaq staff to a Hearings Panel. FibroGen currently meets the continued listing requirement for market value of publicly held shares and all other initial listing standards of The Nasdaq Stock Market, with the exception of the bid price requirement. FibroGen intends to actively monitor the closing bid price of its common stock between now and March 11, 2025, and will evaluate available options to resolve the deficiency and regain compliance with the minimum bid price rule. New Risk • Aug 08
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.2% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$203m free cash flow). Negative equity (-US$190m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$84m net loss in 2 years). Shareholders have been diluted in the past year (2.2% increase in shares outstanding). Market cap is less than US$100m (Mex$882.7m market cap, or US$46.2m). Reported Earnings • Aug 07
Second quarter 2024 earnings released: US$0.16 loss per share (vs US$0.90 loss in 2Q 2023) Second quarter 2024 results: US$0.16 loss per share (improved from US$0.90 loss in 2Q 2023). Revenue: US$50.6m (up 14% from 2Q 2023). Net loss: US$15.5m (loss narrowed 82% from 2Q 2023). Revenue is expected to decline by 5.0% p.a. on average during the next 3 years, while revenues in the Global Biotechs industry are expected to grow by 18%. Annuncio • Aug 01
FibroGen, Inc. Announces Topline Results from Two Late-Stage Pamrevlumab Pancreatic Cancer Studies FibroGen, Inc. announced topline results from two late-stage trials evaluating the efficacy and safety of pamrevlumab in patients with pancreatic cancer. The pamrevlumab experimental arm in PanCAN’s Precision Promise Phase 2/3 adaptive platform trial compared treatment with pamrevlumab combined with gemcitabine + nab-paclitaxel to gemcitabine + nab-paclitaxel alone for treatment in first line (1L) and second line (2L) patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). The pamrevlumab arm of the study did not meet the primary endpoint of overall survival as determined by the protocol pre-specified Bayesian statistical analysis. The Phase 3 LAPIS trial compared treatment with pamrevlumab combined with gemcitabine + nab-paclitaxel or FOLFIRINOX to placebo combined with gemcitabine + nab-paclitaxel or FOLFIRINOX for the treatment of locally advanced, unresectable pancreatic cancer (LAPC). The study did not meet the primary endpoint of overall survival. Based upon the results of the late-stage pamrevlumab trials in pancreatic cancer, the company plans to implement an immediate and significant cost reduction plan in the U.S. The pamrevlumab development program will be terminated and the Company plans to expeditiously wind down any remaining pamrevlumab obligations. As a result of the cost reduction plan, headcount in the U.S. will be reduced by approximately 75%. PanCAN’s Precision Promise Pamrevlumab Arm Efficacy Results: Given both 1L and 2L pamrevlumab treatment groups graduated into Stage 2 of PanCAN’s Precision Promise study, the hazard ratio for the primary overall survival (OS) analysis assumed a common hazard ratio to estimate a single treatment effect for both 1L and 2L pamrevlumab patients combined compared to patients treated with gemcitabine + nab-paclitaxel. In addition, the pre-specified Bayesian model utilized a hierarchical model that included the borrowing of data from the mFOLFIRINOX control arm to the gemcitabine + nab-paclitaxel control arm for the primary efficacy analysis. The pre-specified primary efficacy analysis was performed in a modified intention-to-treat (mITT) population that included only subjects who initiated treatment. The mITT population in the pamrevlumab arm was comprised of a total of 102 patients in the 1L treatment group and 111 patients in the 2L treatment group and the gemcitabine + nab-paclitaxel control arm was comprised of a total of 34 patients in the 1L treatment group and 36 patients in the 2L treatment group. LAPIS Efficacy Results: The study did not meet the primary endpoint of overall survival (stratified log-rank p-value=0.55). Median overall survival of 17.3 months was observed in the pamrevlumab combined with gemcitabine + nab-paclitaxel or FOLFIRINOX arm compared to median overall survival of 17.9 months in the control arm of placebo combined with gemcitabine + nab-paclitaxel or FOLFIRINOX (HR: 1.08; 95% CI – 0.83 to 1.41). Pamrevlumab Safety Results (Precision Promise and LAPIS): The preliminary safety analyses across both studies indicate that the safety profile of pamrevlumab combined with gemcitabine + nab-paclitaxel or FOLFIRINOX was generally well tolerated with an acceptable safety profile in pancreatic cancer patients. No clinically meaningful differences in treatment emergent adverse events were seen between the treatment arms. Annuncio • Jul 31
FibroGen, Inc. to Report Q2, 2024 Results on Aug 06, 2024 FibroGen, Inc. announced that they will report Q2, 2024 results After-Market on Aug 06, 2024 Annuncio • Jul 03
FibroGen, Inc.(NasdaqGS:FGEN) dropped from Russell 3000 Index FibroGen, Inc.(NasdaqGS:FGEN) dropped from Russell 3000 Index Recent Insider Transactions • Jun 14
Senior VP & Chief Medical Officer recently bought Mex$486k worth of stock On the 12th of June, Deyaa Adib bought around 22k shares on-market at roughly Mex$21.98 per share. This transaction amounted to 37% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought Mex$1.8m more in shares than they have sold in the last 12 months. Annuncio • Jun 05
FibroGen, Inc. Announces FDA Clearance of Investigational New Drug Application for FG-3165, A Galectin-9 Targeting Monoclonal Antibody, for the Treatment of Patients with Solid Tumors FibroGen, Inc. announced that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug (IND) of FG-3165, a galectin-9 (Gal9) targeted monoclonal antibody under development for treatment of solid tumors characterized by high Gal9 levels of expression. The FDA IND clearance enables FibroGen to initiate a Phase 1 clinical trial evaluating the safety and efficacy of FG-3165 in patients with select solid tumors. The trial is anticipated to begin enrollment in the second half of 2024. FG-3165 is a galectin-9 (“Gal9”) targeted antibody under development for treatment of solid tumors and potentially hematologic malignancies characterized by high Gal9 levels of expression. Gal9 has been reported to signal through multiple immune checkpoints on lymphocytes, including TIM3, VISTA, and PD-1, suppressing T and natural killer cell activation. FG-3165 selectively binds to Gal9 with high affinity and inhibits its ability to induce lymphocyte cell death, resulting in enhanced tumor cell killing. Toxicology material as well as GMP material for the upcoming Phase 1 clinical trial was manufactured in partnership with Just-Evotec Biologics. Annuncio • May 24
FibroGen Announces Presentation of Positive Interim Data from the Phase 1b Study of FG-3246 (FOR46) in Combination with Enzalutamide in Patients with Metastatic Castration Resistant Prostate Cancer at the 2024 American Society of Clinical Oncology Annual Meeting FibroGen, Inc. announced positive interim results from the dose escalation portion of the investigator-sponsored Phase 1b/2 study conducted by the University of California San Francisco of FG-3246 (FOR46), a potential first-in-class anti-CD46 antibody drug conjugate (ADC) with a MMAE-containing payload, in combination with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation includes data from 17 biomarker unselected patients in the dose escalation portion of the trial. Eligibility criteria for the trial included patients who received at least one prior androgen receptor signaling inhibitor (ARSI) while patients who were treated with prior chemotherapy in the castration resistant setting were excluded. Over 70% of the patients in the study received at least two prior ARSIs, which included prior enzalutamide treatment. Dose escalation was explored with and without prophylactic granulocyte colony-stimulating factor (G-CSF) support. The primary endpoint was determination of the maximally tolerated dose (MTD) of FG-3246 in combination with enzalutamide. The combination treatment demonstrated an encouraging preliminary estimate of median radiographic progression free survival (rPFS) of 10.2 months. The MTD was established at 2.1 mg/kg ABW, with primary G-CSF prophylaxis, in combination with enzalutamide 160 mg/day. The most frequent adverse events were consistent with other MMAE-based ADCs and included fatigue, weight loss, elevated transaminases, neutropenia, and peripheral neuropathy. Additionally, a baseline CD46-directed PET imaging probe utilizing the same antibody backbone as FG-3246 (89Zr-DFO-YS5) was obtained in a subset of patients and demonstrated tumor uptake in multiple lesions. This Phase 1b/2 study is an investigator-sponsored trial being conducted at the University of California San Francisco to evaluate FG-3246 (FOR46) in combination with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) after prior progression on at least one androgen receptor signaling inhibitor. The primary objective for the Phase 1b portion of the study is to determine the maximally tolerated dose (MTD) and recommended Phase 2 dose of FG-3246 in combination with enzalutamide in patients with mCRPC. The objectives of the Phase 2 portion of the study are to determine the composite response rate (CRR), proportion of participants with a greater than or equal to 50% change in prostate specific antigen (PSA50), objective response rate (ORR), median duration of response, median radiographic progression free survival (rPFS), and median overall survival (OS) of patients treated with FG-3246 in combination with enzalutamide. Reported Earnings • May 07
First quarter 2024 earnings released: US$0.33 loss per share (vs US$0.81 loss in 1Q 2023) First quarter 2024 results: US$0.33 loss per share (improved from US$0.81 loss in 1Q 2023). Revenue: US$55.9m (up 55% from 1Q 2023). Net loss: US$32.9m (loss narrowed 57% from 1Q 2023). Revenue is forecast to grow 1.9% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Global Biotechs industry. Board Change • May 06
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 6 experienced directors. 3 highly experienced directors. CEO & Director Thane Wettig was the last director to join the board, commencing their role in 2023. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Annuncio • May 01
FibroGen, Inc. to Report Q1, 2024 Results on May 06, 2024 FibroGen, Inc. announced that they will report Q1, 2024 results After-Market on May 06, 2024 Annuncio • Apr 17
Hangzhou Andao Pharmaceutical Ltd. and Kind Pharmaceuticals Announce Settlement with FibroGen, Inc Hangzhou Andao Pharmaceutical Ltd. and Kind Pharmaceuticals LLC, together with its Chief Executive Officer Dr. Dong Liu and Chief Scientific Officer Dr. Shaojiang Deng, announced a resolution of their recent dispute with FibroGen, Inc. regarding Kind Pharmaceuticals' hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF- PHI) technology. The parties have agreed to withdraw all pending legal proceedings between them regarding this HIF-PHI technology, without payment by either party. HIF-PHIs are a class of compounds that can be used to treat anemia. Kind Pharmaceuticals' HIF-PHI drug candidate, AND017, is currently being studied in a clinical trial for the treatment of anemia in chronic kidney disease (CKD) patients. As a result of the settlement, Kind Pharmaceuticals remains free to develop AND017 and other HIF-PHIs in its pipeline. Board Change • Apr 09
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 6 experienced directors. 3 highly experienced directors. CEO & Director Thane Wettig was the last director to join the board, commencing their role in 2023. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Annuncio • Apr 03
Fibrogen Announces Topline Results from Phase 1 Monotherapy Study of FG-3246 in Patients with Metastatic Castration-Resistant Prostate Cancer FibroGen, Inc. announced topline data from the Fortis Therapeutics-sponsored Phase 1 study of FG-3246 (also known as FOR46), a potential first-in-class anti-CD46 antibody drug conjugate (ADC) with an MMAE-containing payload, in a dose-escalation and dose-expansion trial enrolling patients with metastatic castration-resistant prostate cancer (mCRPC) whose tumors have progressed on at least one androgen receptor-signaling inhibitor (ARSI). In the Phase 1 dose-escalation portion of the study, ascending dose levels of FG-3246 were administered every 3 weeks. In the dose-expansion arm of the trial, patients were treated at the 2.7 mg/kg adjusted body weight dosing (AjBW) until disease progression. The endpoints were safety, tolerability, and anti-tumor activity as measured by the decline of prostate-specific antigen (PSA) from baseline, objective tumor response rate in patients with measurable disease, and radiographic progression free survival (rPFS). The completed Phase 1 trial includes a total of 56 patients from the dose-escalation and dose-expansion cohorts. The efficacy analysis includes patients who received a starting dose of FG-3246 of = 1.2 mg/kg in the dose-escalation cohort, and patients who received 2.7 mg/kg AjBW with a histologic diagnosis of adenocarcinoma in the dose-expansion cohort. Patients were heavily pre-treated, having received a median of 5 lines of therapy prior to receiving FG-3246. In the efficacy analysis, PSA reductions of = 50% were observed in 36% of PSA evaluable patients. For RECIST evaluable patients, 20% met the criteria of a partial response, or tumor reduction in size of = 30%, with a median duration of response of 7.5 months. The median rPFS in this heavily pre-treated patient population was 8.7 months. The most frequent adverse events were consistent with other MMAE-based ADCs and included infusion related reactions, fatigue, weight loss, neutropenia, and peripheral neuropathy. Earlier data from the FOR46-001 trial had been presented at the American Society for Clinical Oncology (ASCO) 2022 annual meeting1, and complete results from the study are being submitted to a medical journal for publication in 2024. Recent Insider Transactions • Mar 13
CEO & Director recently bought Mex$1.6m worth of stock On the 7th of March, Thane Wettig bought around 50k shares on-market at roughly Mex$32.23 per share. This transaction amounted to 47% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Thane has been a buyer over the last 12 months, purchasing a net total of Mex$555k worth in shares. Annuncio • Mar 11
FibroGen Appoints Deyaa Adib as Senior Vice President and Chief Medical Officer FibroGen, Inc. announced the appointment of Deyaa Adib, M.D., an executive leader with almost three decades of oncology development experience, as Senior Vice President & Chief Medical Officer to oversee all global clinical development activities. The appointment is effective March 11, 2024. Dr. Adib, a seasoned industry leader, has over 27 years of medical oncology experience in the biotechnology and pharmaceutical industries, including seven successful registrations across solid tumor and hematologic malignancy indications. Prior to joining FibroGen, he was the Chief Medical Officer of Triumvira Immunologics Inc. where he led the transition of two novel cell therapy programs into clinical development. He previously served as Acting Chief Medical Officer at Rain Therapeutics, and as Vice President of late-stage development at Blueprint Medicines, where he led the development of avapritinib which is currently approved for gastrointestinal stromal tumors and advanced systemic mastocytosis. Dr. Adib also served as Global Therapeutics Head for solid tumors at Baxalta, in-licensing and advancing the development of nanoliposomal irinotecan that was subsequently approved globally for pancreatic cancer, establishing a new standard of care in the second line metastatic setting. He also served as Head of Hematologic Malignancies at ARIAD Pharmaceuticals, leading the global clinical program for ponatinib in chronic myeloid leukemia. Earlier in his career, Dr. Adib held multiple oncology clinical development leadership positions at Aventis, Sanofi and Astellas Pharma, advancing the development of Taxotere in prostate cancer, breast cancer and gastric cancer, oxaliplatin in colorectal cancer and notably enzalutamide, which led to a treatment paradigm shift in prostate cancer. He has served as a scientific advisory board member for multiple biotech companies and provided strategic consulting support to several cell therapy startups. Dr. Adib obtained an M.B., B.Ch. degree from Cairo University School of Medicine in Cairo, Egypt. He completed his postgraduate medical oncology training at the Anglo-American Cancer Institute in Cairo and additionally at Tufts University School of Medicine, Boston, MA, in clinical pharmacology, drug development and regulation. Reported Earnings • Feb 27
Full year 2023 earnings released: US$2.92 loss per share (vs US$3.14 loss in FY 2022) Full year 2023 results: US$2.92 loss per share (improved from US$3.14 loss in FY 2022). Revenue: US$147.8m (up 5.0% from FY 2022). Net loss: US$284.2m (loss narrowed 3.2% from FY 2022). Revenue is forecast to grow 10% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Global Biotechs industry. Annuncio • Feb 21
FibroGen, Inc. to Report Q4, 2023 Results on Feb 26, 2024 FibroGen, Inc. announced that they will report Q4, 2023 results After-Market on Feb 26, 2024 New Risk • Feb 04
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$352m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$352m free cash flow). Shares are highly illiquid. Negative equity (-US$115m). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$140m net loss next year). Shareholders have been diluted in the past year (4.7% increase in shares outstanding). Board Change • Feb 01
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 6 experienced directors. 3 highly experienced directors. CEO & Director Thane Wettig was the last director to join the board, commencing their role in 2023. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Annuncio • Jan 25
FibroGen, Inc. Announces Completion of the Pamrevlumab Arm in Precision Promise, Pancreatic Cancer Action Network’s Phase 2/3 Adaptive Platform Trial for Metastatic Pancreatic Cancer FibroGen, Inc. announced graduation and completion of the pamrevlumab experimental arm in the Pancreatic Cancer Action Network's (PanCAN) Precision PromiseSM Phase 2/3 adaptive platform trial, which evaluates pamrevlumab in combination with the chemotherapy treatments gemcitabine and nab-paclitaxel for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). Topline data from this registration study is anticipated in the second quarter of 2024. Pamrevlumab, in Stage 1 of the trial, achieved a protocol pre-specified = 35% predictive probability of success for the primary endpoint of overall survival at the completion of the trial, and thus graduated to the second and final Stage of the trial in the third quarter of 2022. Pamrevlumab is the first experimental arm to meet its required threshold for graduation to Stage 2 in the adaptive platform trial. The pamrevlumab arm of the study completed Stage 2 of the trial in January 2024. PanCAN’s Precision PromiseSM adaptive platform trial (NCT04229004) is a U.S.-based, seamless Phase 2/3 study that enrolled patients in approximately 24 sites around the country. The multi-arm study consists of experimental treatment arms and two comparator arms: gemcitabine + nab-paclitaxel and mFOLFIRINOX. The pamrevlumab experimental arm was offered to patients with mPDAC as either a first-line (1L) or second-line (2L) treatment option. In the initial stage of the study (Stage 1), at least 100 patients with mPDAC received pamrevlumab in combination with gemcitabine and nab-paclitaxel. Guided by Bayesian principles, the graduation threshold for pamrevlumab was a protocol pre-specified = 35% predictive probability of success for the primary endpoint of overall survival at the completion of the trial. Upon graduation, an additional 75 patients with mPDAC were enrolled (Stage 2), receiving the same pamrevlumab treatment regimen as in Stage 1. All patients are dosed until disease progression and the final analysis is based upon the data collected up to 12 months after the last patient initiates treatment in Stage 2. The combined Stage 1 and Stage 2 data will form the basis for analysis of the primary and secondary endpoints for the pamrevlumab arm. Secondary endpoints include progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR), offering a comprehensive understanding of the treatment's impact. Biomarker-related data, including genomics data, have been collected to provide additional insights into the trial's outcomes. Precision PromiseSM is a registration study and the statistical design has been discussed by PanCAN with the FDA. The statistical design of Precision PromiseSM is led by renowned statistician Dr. Donald Berry of Berry Consulting. Board Change • Jan 11
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 6 experienced directors. 3 highly experienced directors. CEO & Director Thane Wettig was the last director to join the board, commencing their role in 2023. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Annuncio • Oct 29
FibroGen, Inc. Receives Non-Compliance Letter from Nasdaq Related to Minimum Bid Price On October 24, 2023, FibroGen, Inc. (FibroGen) received a letter from the Nasdaq Listing Qualifications Staff of The Nasdaq Stock Market notifying FibroGen that for the last 30 consecutive business days the bid price of FibroGens common stock had closed below $1.00 per share, the minimum closing bid price required by the continued listing requirements of Nasdaq listing rule 5450(a)(1). The notification received has no immediate effect on the listing of FibroGens common stock on Nasdaq. In accordance with listing rule 5810(c)(3)(A), FibroGen has 180 calendar days, or until April 22, 2024, to regain compliance with the minimum bid price rule. To regain compliance, the closing bid price of FibroGens common stock must be at least $1.00 per share for a minimum of ten consecutive business days (or such longer period of time as the Nasdaq staff may require in some circumstances, but generally not more than 20 consecutive business days) before April 22, 2024. If FibroGens common stock does not achieve compliance by April 22, 2024, FibroGen may be eligible for an additional 180-day period to regain compliance if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards, with the exception of the bid price requirement, and provides written notice to Nasdaq of its intention to cure the deficiency during the second compliance period, including by effecting a reverse stock split, if necessary. However, if it appears to the Nasdaq staff that FibroGen will not be able to cure the deficiency, or if FibroGen does not meet the other listing standards, Nasdaq could provide notice that FibroGens common stock will become subject to delisting. In the event FibroGen receives notice that its common stock is being delisted, Nasdaq rules permit FibroGen to appeal any delisting determination by the Nasdaq staff to a Hearings Panel. FibroGen currently meets the continued listing requirement for market value of publicly held shares and all other initial listing standards of The Nasdaq Stock Market, with the exception of the bid price requirement. FibroGen intends to actively monitor the closing bid price of its common stock between now and April 22, 2024, and will evaluate available options to resolve the deficiency and regain compliance with the minimum bid price rule. Annuncio • Oct 24
FibroGen, Inc. to Report Q3, 2023 Results on Nov 06, 2023 FibroGen, Inc. announced that they will report Q3, 2023 results After-Market on Nov 06, 2023 Annuncio • Sep 08
Mark Eisner Resigns as Chief Medical Officer of Fibrogen, Inc., Effective September 8, 2023 On August 31, 2023, Mark Eisner, M.D. resigned from his position as Chief Medical Officer of FibroGen, Inc., effective September 8, 2023, to pursue other opportunities. Dr. Eisner will continue as an employee through the effective date of his resignation, after which time, he will serve the company as a consultant under a consulting agreement (the ‘Consulting Agreement’) to provide transition services. The company has commenced a search for a new Chief Medical Officer. Board Change • Sep 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 7 experienced directors. 2 highly experienced directors. Independent Director Ben Cravatt was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Annuncio • Aug 31
Fibrogen, Inc. Announces Topline Results from Lelantos-2, A Phase 3 Clinical Study of Pamrevlumab in Ambulatory Muscular Dystrophy FibroGen, Inc. announced topline data from the Phase 3 LELANTOS-2 trial of pamrevlumab for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD) on background systemic corticosteroids. The study did not meet the primary endpoint of change in the North Star Ambulatory Assessment (NSAA) total score from baseline to week 52 (placebo-corrected mean difference -0.528 points; 95% CI -2.308 to 1.251; p=0.5553). Secondary endpoints measured by change from baseline at week 52 in 4-stair climb velocity, 10-meter walk/run test, time to stand, time to loss of ambulation, and proportion of patients with greater than 10 seconds in the 10-meter walk/run test were also not met. Preliminary safety data showed that pamrevlumab was generally safe and well tolerated. The majority of treatment emergent adverse events were mild or moderate. Treatment-emergent serious adverse events were observed in 8.3% of patients in the pamrevlumab group and 2.8% of patients in the placebo group. FibroGen is in the process of evaluating the totality of the data, including other pre-specified endpoints, to determine the next steps for the program. The Company plans to communicate the full results of the LELANTOS-2 study at an upcoming medical forum. A total of 73 boys with ambulatory DMD ages 6 to <12 years were enrolled in LELANTOS-2, a global, Phase 3, randomized, double-blind trial of pamrevlumab or placebo in combination with systemic corticosteroids. The primary endpoint of the study was ambulatory function measured by change in the North Star Ambulatory Assessment (NSAA) total score from baseline to Week 52. Secondary endpoints assessed from baseline to Week 52 included changes in 4-stair climb velocity, 10-meter walk/run test, time to stand, time to loss of ambulation, and proportion of patients with greater than 10 seconds in the 10-meter walk/run test. In LELANTOS-2, patients were dosed with pamrevlumab (35 mg/kg IV on Day 1 and every two weeks thereafter with last dose at Week 52) or placebo. Duchenne muscular dystrophy (DMD) is a rare and debilitating neuromuscular disease that affects approximately 1 in every 5,000 newborn boys. About 20,000 children are diagnosed with DMD globally each year. The fatal disease is caused by a genetic mutation leading to the absence or defect of dystrophin, a protein necessary for normal muscle function. The absence of dystrophin results in muscle weakness, muscle loss, fibrosis, and inflammation. Patients with DMD are often wheelchair-bound before the age of 12, and their progressive muscle weakness may lead to serious medical problems relating to respiratory and cardiac muscle. Pamrevlumab is a potential first-in-class antibody being developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is in Phase 3 clinical development for the treatment of ambulatory Duchenne muscular dystrophy (DMD), and locally advanced unresectable pancreatic cancer (LAPC), and in Phase 2/3 for the treatment of metastatic pancreatic cancer. The U.S. Food and Drug Administration has granted Orphan Drug Designation to pamrevlumab for treatment of patients with DMD and pancreatic cancer, and Fast Track designation to pamrevlumab for the treatment of patients with DMD and LAPC. The U.S. Food and Drug Administration has also granted Rare Pediatric Disease Designation to pamrevlumab for the treatment of patients with DMD. Pamrevlumab has demonstrated a safety and tolerability profile that has supported ongoing clinical investigation in DMD, LAPC, and metastatic pancreatic cancer. Reported Earnings • Aug 08
Second quarter 2023 earnings released: US$0.90 loss per share (vs US$0.78 loss in 2Q 2022) Second quarter 2023 results: US$0.90 loss per share (further deteriorated from US$0.78 loss in 2Q 2022). Revenue: US$44.3m (up 49% from 2Q 2022). Net loss: US$87.7m (loss widened 21% from 2Q 2022). Revenue is forecast to grow 10% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Global Biotechs industry. Annuncio • Jul 26
Fibrogen, Inc. Announces Chief Executive Officer Changes FibroGen Inc. CEO Enrique Conterno resigned for personal reasons. Thane Wettig, FibroGen's chief commercial officer, was named interim CEO of the San Francisco-based drug maker. Conterno, a 27-year veteran of Eli Lilly and Co., joined FibroGen as the virus that causes Covid was emerging in China, one of the company's top markets for roxadustat. He replaced company founder Thomas Neff, who died in August 2019 at the age of 65 of advanced hypertensive cardiovascular disease. Wettig, 58, has been with FibroGen since June 2020. He had been chief commercial officer and metabolic franchise head for Intarcia Therapeutics for two years and spent 18 years at Lilly, most recently as chief marketing officer of its diabetes business. Annuncio • Jul 25
FibroGen, Inc. to Report Q2, 2023 Results on Aug 07, 2023 FibroGen, Inc. announced that they will report Q2, 2023 results After-Market on Aug 07, 2023 Annuncio • Jun 08
FibroGen, Inc. Announces Topline Results from LELANTOS-1 Phase 3 Clinical Study of Pamrevlumab in Non-Ambulatory Patients with Duchenne Muscular Dystrophy FibroGen, Inc. announced topline data from the Phase 3 LELANTOS-1 placebo-controlled trial of pamrevlumab for the treatment of non-ambulatory patients with Duchenne Muscular Dystrophy (DMD) on background corticosteroids. The study did not meet the primary endpoint of Performance of the Upper Limb 2.0 (PUL 2.0) score at week 52 compared to baseline. Pamrevlumab was generally safe and well tolerated and the majority of treatment emergent adverse events were mild or moderate. FibroGen plans to present the complete results of the LELANTOS-1 study at an upcoming medical conference and to publish the full results. Topline data from the Phase 3 LELANTOS-2 clinical trial of pamrevlumab for the treatment of ambulatory patients with DMD is expected Third Quarter 2023. A total of ninety-nine (99) DMD patients aged 12 years and older were enrolled in LELANTOS-1, a global Phase 3, randomized, double-blind, trial of pamrevlumab or placebo in combination with systemic corticosteroids to evaluate the efficacy and safety of pamrevlumab in patients with non-ambulatory DMD. The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease, Orphan Drug, and Fast Track Designation to pamrevlumab for the treatment of DMD. In the EU, FibroGen has been granted Orphan Drug Designation to pamrevlumab for the treatment of DMD. The Phase 3 clinical development program for pamrevlumab for DMD includes two studies, LELANTOS-1 and LELANTOS-2. These randomized, double-blind global Phase 3 trials are designed to evaluate the efficacy and safety of pamrevlumab in combination with systemic corticosteroids in patients with either non-ambulatory or ambulatory DMD. For more information about LELANTOS-2, which is fully enrolled. Pamrevlumab is a potential first-in-class antibody being developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD), and in Phase 2/3 for the treatment of metastatic pancreatic cancer. The U.S. Food and Drug Administration has granted Orphan Drug Designation, and Fast Track designation to pamrevlumab for the treatment of patients with IPF, DMD, and LAPC. The U.S. Food and Drug Administration has also granted Rare Pediatric Disease Designation to pamrevlumab for the treatment of patients with DMD. Pamrevlumab has demonstrated a safety and tolerability profile that has supported ongoing clinical investigation in IPF, DMD, and LAPC. Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. Annuncio • May 19
FibroGen, Inc. Announces Positive Topline Results from China Pivotal Phase 3 Clinical Trial of Roxadustat for the Treatment of Chemotherapy Induced Anemia FibroGen, Inc. and its subsidiary, FibroGen (China) Medical Technology Development Co. Ltd. announced positive topline data from Company's Phase 3 clinical study of roxadustat for treatment of anemia in patients receiving concurrent chemotherapy treatment for non-myeloid malignancies in China. Roxadustat (Ai Rui Zhuo ®?) demonstrated non-inferiority compared to recombinant erythropoietin alfa (SEPO®?) on the primary endpoint of change in hemoglobin (Hb) level from baseline to the average level during weeks 9-13. In the preliminary safety analysis, the adverse event profile of roxadustat was generally consistent with previous findings and supportive of a positive benefit risk in this patient population. A total of one-h hundred fifty-nine (159) patients with non-myeloid malignedancy (solid tumor) with a baseline hemoglobin level at or below 10 g/dL were enrolled into this Phase 3, randomized, open-label, active-controlled study investigating the efficacy and safety of roxadustat For treatment of chemotherapy-induced anemia (CIA). Patients were randomly assigned roxadustat or erythropoietin Alfa three times per week (TIW), during a treatment period of 12 weeks, with an additional 4-week follow-up period. Roxadustat (ai Rui Zhuo ®®?, EVRENZOTM) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in CKD patients on dialysis and not on dialysis. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) in China. FibroGen recently expanded its research and development portfolio to include product candidates in the immuno-oncology space. Recent Insider Transactions • Apr 07
Insider recently sold Mex$2.2m worth of stock On the 4th of April, Christine Chung sold around 7k shares on-market at roughly Mex$341 per share. This transaction amounted to 2.5% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth Mex$21m. Insiders have been net sellers, collectively disposing of Mex$46m more than they bought in the last 12 months. Annuncio • Feb 18
FibroGen, Inc. to Report Q4, 2022 Results on Feb 27, 2023 FibroGen, Inc. announced that they will report Q4, 2022 results After-Market on Feb 27, 2023 Recent Insider Transactions • Jan 15
CEO & Director recently sold Mex$589k worth of stock On the 6th of January, Enrique Conterno sold around 2k shares on-market at roughly Mex$383 per share. This transaction amounted to 1.8% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Enrique's only on-market trade for the last 12 months. Recent Insider Transactions • Jan 13
CEO & Director recently sold Mex$589k worth of stock On the 6th of January, Enrique Conterno sold around 2k shares on-market at roughly Mex$383 per share. This transaction amounted to 1.8% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Enrique's only on-market trade for the last 12 months. Recent Insider Transactions • Dec 30
Executive VP & Chief Commercial Officer recently sold Mex$225k worth of stock On the 23rd of December, Thane Wettig sold around 734 shares on-market at roughly Mex$307 per share. This transaction amounted to 3.0% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months. Reported Earnings • Nov 08
Third quarter 2022 earnings released: US$0.98 loss per share (vs US$0.54 profit in 3Q 2021) Third quarter 2022 results: US$0.98 loss per share (down from US$0.54 profit in 3Q 2021). Revenue: US$15.7m (down 90% from 3Q 2021). Net loss: US$91.7m (down 284% from profit in 3Q 2021). Revenue is forecast to grow 26% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Global Biotechs industry. Over the last 3 years on average, earnings per share has fallen by 37% per year but the company’s share price has only fallen by 19% per year, which means it has not declined as severely as earnings. Reported Earnings • Aug 09
Second quarter 2022 earnings released: US$0.78 loss per share (vs US$1.45 loss in 2Q 2021) Second quarter 2022 results: US$0.78 loss per share (up from US$1.45 loss in 2Q 2021). Revenue: US$29.8m (up 22% from 2Q 2021). Net loss: US$72.6m (loss narrowed 46% from 2Q 2021). Over the next year, revenue is expected to shrink by 20% compared to a 245% growth forecast for the industry in Mexico. Reported Earnings • Mar 02
Full year 2021 earnings: EPS in line with expectations, revenues disappoint Full year 2021 results: US$3.14 loss per share (down from US$2.11 loss in FY 2020). Revenue: US$235.3m (up 34% from FY 2020). Net loss: US$290.0m (loss widened 53% from FY 2020). Revenue missed analyst estimates by 12%. Over the next year, revenue is expected to shrink by 17% compared to a 148% growth forecast for the pharmaceuticals industry in Mexico. Over the last 3 years on average, earnings per share has fallen by 52% per year but the company’s share price has only fallen by 38% per year, which means it has not declined as severely as earnings. Reported Earnings • Nov 11
Third quarter 2021 earnings released: EPS US$0.54 (vs US$0.36 in 3Q 2020) The company reported a solid third quarter result with improved earnings and revenues, although profit margins were weaker. Third quarter 2021 results: Revenue: US$156.0m (up 254% from 3Q 2020). Net income: US$49.8m (up 51% from 3Q 2020). Profit margin: 32% (down from 75% in 3Q 2020). The decrease in margin was driven by higher expenses. Over the last 3 years on average, earnings per share has fallen by 41% per year but the company’s share price has only fallen by 33% per year, which means it has not declined as severely as earnings. Recent Insider Transactions • Sep 21
Independent Director recently sold Mex$3.0m worth of stock On the 15th of September, Thomas Kearns sold around 13k shares on-market at roughly Mex$230 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of Mex$2.3m more than they bought in the last 12 months. Recent Insider Transactions • Sep 01
Chief Commercial Officer recently bought Mex$727k worth of stock On the 26th of August, Thane Wettig bought around 3k shares on-market at roughly Mex$235 per share. This was the largest purchase by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months. Reported Earnings • Aug 11
Second quarter 2021 earnings released: US$1.45 loss per share (vs US$0.95 loss in 2Q 2020) The company reported a poor second quarter result with increased losses, weaker revenues and weaker control over costs. Second quarter 2021 results: Revenue: US$24.4m (down 43% from 2Q 2020). Net loss: US$134.0m (loss widened 57% from 2Q 2020). Executive Departure • Jul 13
Independent Director Kalevi Kurkijärvi has left the company On the 30th of June, Kalevi Kurkijärvi's tenure as Independent Director ended after 24.7 years in the role. As of March 2021, Kalevi still personally held 28.40k shares (Mex$18m worth at the time). A total of 2 executives have left over the last 12 months. The current median tenure of the management team is 5.04 years. Breakeven Date Change • May 22
Forecast to breakeven in 2025 The 10 analysts covering FibroGen expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$67.0m in 2025. Average annual earnings growth of 32% is required to achieve expected profit on schedule. Reported Earnings • May 12
First quarter 2021 earnings released: US$0.78 loss per share (vs US$0.89 loss in 1Q 2020) The company reported a solid first quarter result with reduced losses, improved revenues and improved control over expenses. First quarter 2021 results: Revenue: US$38.4m (up 57% from 1Q 2020). Net loss: US$71.8m (loss narrowed 8.4% from 1Q 2020). Over the last 3 years on average, earnings per share has fallen by 25% per year whereas the company’s share price has fallen by 27% per year. Executive Departure • Mar 17
Executive Advisor to Chief Executive Officer K. Yu has left the company On the 15th of March, K. Yu, was replaced as CEO by Enrique Conterno. As of December 2020, Yu personally held 116.10k shares (Mex$89m worth at the time). A total of 3 executives have left over the last 12 months. Reported Earnings • Mar 03
Full year 2020 earnings released: US$2.11 loss per share (vs US$0.89 loss in FY 2019) The company reported a poor full year result with increased losses, weaker revenues and weaker control over costs. Full year 2020 results: Revenue: US$176.3m (down 31% from FY 2019). Net loss: US$189.3m (loss widened 146% from FY 2019). Products in clinical trials Phase II: 1 Phase III: 4 Over the last 3 years on average, earnings per share has fallen by 17% per year but the company’s share price has only fallen by 9% per year, which means it has not declined as severely as earnings. Analyst Estimate Surprise Post Earnings • Mar 03
Revenue misses expectations Revenue missed analyst estimates by 17%. Over the next year, revenue is forecast to grow 172%, compared to a 1,114% growth forecast for the Biotechs industry in Mexico. Annuncio • Oct 30
FibroGen, Inc. to Report Q3, 2020 Results on Nov 05, 2020 FibroGen, Inc. announced that they will report Q3, 2020 results at 5:00 PM, Eastern Standard Time on Nov 05, 2020