Welcome to our dedicated page for Fibrogen news (Ticker: FGEN), a resource for investors and traders seeking the latest updates and insights on Fibrogen stock.
FibroGen Inc (NASDAQ: FGEN) is a clinical-stage biopharmaceutical company pioneering novel therapies for oncology and anemia through innovative HIF biology and antibody-drug conjugate research. This page serves as the definitive source for verified FibroGen news and official communications, providing stakeholders with timely updates on clinical developments and corporate milestones.
Investors and industry observers will find essential information including clinical trial results, regulatory submissions, and strategic partnership announcements. Our curated feed includes earnings reports, research publications, and manufacturing updates directly impacting FibroGen's progress in bringing targeted therapies to market.
Key content categories cover advancements in the company's HIF-PH inhibitor programs for anemia management, ADC oncology candidates, and updates from global collaborations. All materials are sourced from primary corporate disclosures to ensure accuracy and compliance with financial reporting standards.
Bookmark this page for streamlined access to FibroGen's latest developments. Check regularly for critical updates on pipeline progress, peer-reviewed study data, and market-moving announcements relevant to FGEN shareholders and industry analysts.
FibroGen is set to present new findings on roxadustat at the ASN Kidney Week 2020, highlighting its efficacy in treating anemia in patients with chronic kidney disease (CKD). The studies will explore various patient demographics, including dialysis-dependent and non-dialysis-dependent groups, and will address the safety profile regarding cardiovascular risks and hospitalizations. The data suggests potential reductions in the need for red blood cell transfusions and emphasizes roxadustat's promise as a foundational treatment option for CKD-related anemia.
FibroGen, Inc. has appointed Percy Carter as the Chief Scientific Officer to enhance its research efforts. Dr. Carter brings over 20 years of biopharmaceutical experience, previously serving as Global Head of Discovery Sciences at Janssen. His background includes significant roles at Bristol-Myers Squibb and DuPont Pharmaceuticals, highlighting his leadership in drug discovery. CEO Enrique Conterno emphasized the importance of Dr. Carter's expertise in advancing FibroGen's unique therapeutic developments, particularly in hypoxia-inducible factor and connective tissue growth factor biology.
FibroGen, a biopharmaceutical company, announced CEO Enrique Conterno's participation in virtual healthcare conferences on September 9 and September 16, 2020. He will speak at the Citigroup 15th Annual BioPharma Conference at 2:25 PM ET and the Morgan Stanley 18th Annual Global Healthcare Conference at 3:30 PM ET. A live audio webcast can be accessed on the FibroGen Investor webpage, with replays available for 30 days. FibroGen focuses on developing innovative treatments for unmet medical needs, including roxadustat for chronic kidney disease anemia and pamrevlumab for various conditions.
FibroGen (NASDAQ: FGEN) has initiated the LELANTOS Phase 3 clinical trial to evaluate pamrevlumab in patients with non-ambulatory Duchenne muscular dystrophy (DMD). The study aims to assess muscle function improvement over 52 weeks in approximately 90 patients receiving pamrevlumab plus corticosteroids or placebo. Key endpoints include changes in upper limb performance and evaluations of pulmonary and cardiac function. This trial marks a significant milestone in FibroGen's DMD program and reflects the company's commitment to addressing this debilitating condition.
FibroGen reported Q2 2020 revenues of $42.9 million, down from $191.6 million year-over-year. This includes $15.7 million in net sales from roxadustat in China. The net loss for the quarter was $85.3 million or $0.95 per share. The company's cash position at the end of June was $716 million, with a year-end forecast of $720-$730 million. The FDA is reviewing the NDA for roxadustat, with a PDUFA date of December 20, 2020. Recent trials for pamrevlumab are ongoing, aiming to address COVID-19 and other conditions.
FibroGen has appointed Dr. Aoife Brennan and Dr. Ben Cravatt to its Board of Directors, effective August 5, 2020. Dr. Brennan brings extensive experience in rare diseases and clinical development from her tenure at Synlogic and Biogen, while Dr. Cravatt is a distinguished professor recognized for his research in chemical biology. Their appointments aim to enhance FibroGen’s strategic direction, particularly in advancing pivotal studies for pamrevlumab and roxadustat, aimed at addressing unmet medical needs.
FibroGen, Inc. (NASDAQ: FGEN) is set to announce its Q2 2020 financial results on August 6, after market close. A conference call for investors will follow at 5:00 p.m. ET to discuss the company's financial performance. FibroGen is recognized for its innovative therapies, notably roxadustat for treating anemia related to chronic kidney disease and other conditions. The company is also developing pamrevlumab for multiple serious diseases, including idiopathic pulmonary fibrosis and pancreatic cancer.
FibroGen announced the initiation of a Phase 2 study evaluating pamrevlumab in hospitalized COVID-19 patients. This double-blind, placebo-controlled trial will enroll approximately 130 patients in the U.S. The primary objective is to assess pamrevlumab's efficacy in improving blood oxygenation, measured by the survival rate of patients not requiring mechanical ventilation by Day 28. Pamrevlumab targets CTGF, aiming to reduce acute respiratory distress syndrome symptoms during COVID-19. A second trial assessing long-term efficacy is also planned.
FibroGen, Inc. (NASDAQ: FGEN) appointed Thane Wettig as Chief Commercial Officer, a key position aimed at enhancing commercialization strategies. Wettig brings over 30 years of biopharmaceutical experience, previously serving at Intarcia Therapeutics and Lilly, where he facilitated the launch of major diabetes medications. His expertise is expected to advance FibroGen’s commercialization efforts for its lead product, roxadustat, targeting anemia in chronic kidney disease patients, and pamrevlumab, aimed at various serious conditions. Wettig's leadership is anticipated to strengthen partnerships with AstraZeneca and Astellas.
FibroGen announced positive results from the Phase 3 DOLOMITES study, showing that roxadustat is non-inferior to darbepoetin alfa in correcting hemoglobin levels in non-dialysis-dependent chronic kidney disease (CKD) patients. In the primary endpoint, 89.5% of patients receiving roxadustat achieved hemoglobin correction compared to 78.0% for darbepoetin alfa. Roxadustat also showed superiority in reducing low-density lipoprotein cholesterol and time to first intravenous iron use. The overall safety profile was comparable between the two treatments.
