FibroGen, Inc - FGEN STOCK NEWS

FibroGen (NASDAQ:FGEN) reported Q3 2020 total revenue of $44.0 million, up from $33.2 million in Q3 2019, driven by strong roxadustat sales of $22.7 million in China. The company achieved a net income of $33.0 million or $0.36 per share, a significant recovery from a net loss of $49.4 million last year. FibroGen also amended its agreement with AstraZeneca to enhance profitability. Upcoming events include discussions on the U.S. NDA for roxadustat with a decision expected by December 20, 2020.

FibroGen, Inc. (NASDAQ: FGEN) will report its third quarter 2020 financial results on November 5, after market close. A conference call will be held at 5:00 p.m. ET to discuss corporate and financial performance. Investors can access the live audio webcast on the company's website. Roxadustat, a drug for anemia associated with chronic kidney disease, is highlighted, along with ongoing developments for related conditions. Pamrevlumab, another investigational therapy, is in clinical trials for multiple serious diseases.

FibroGen announced the results from two analyses of pooled data from the roxadustat global Phase 3 development program, which were presented at the ASN Kidney Week 2020. The analyses revealed that Major Adverse Cardiovascular Events (MACE) rates in chronic kidney disease (CKD) patients were highest when hemoglobin (Hb) was below 8 g/dL. Rates decreased as Hb increased and were lowest when Hb levels reached or exceeded 10 g/dL. This data supports roxadustat's efficacy and potential as a treatment for anemia in CKD patients.

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.