Fibrogen Inc Stock Price, News & Analysis

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.

FibroGen (NASDAQ: FGEN) has initiated a Phase 2/3 clinical trial assessing the efficacy of pamrevlumab in treating severe COVID-19 patients. This open-label study, led by Professor Luca Richeldi in Italy, aims to evaluate pamrevlumab's effects on blood oxygenation in approximately 68 patients hospitalized with COVID-19. Pamrevlumab, an anti-CTGF monoclonal antibody, may reverse pulmonary edema to enhance oxygenation. Additionally, FibroGen plans two more U.S. studies to further investigate pamrevlumab's safety and efficacy in COVID-19 patients, with one trial already approved by the FDA.

Astellas Pharma and FibroGen announced the European Medicines Agency's acceptance of the marketing authorization application for roxadustat to treat anemia in adults with chronic kidney disease (CKD). This application is backed by successful results from a pivotal Phase 3 program involving over 9,000 patients globally. Roxadustat is designed to effectively increase hemoglobin levels while reducing intravenous iron usage. The approval will trigger a $130 million milestone payment from Astellas to FibroGen.

FibroGen (NASDAQ: FGEN) will participate in the virtual Bank of America Securities 2020 Health Care Conference from May 12-14, 2020. CEO Enrique Conterno is set for a fireside chat on May 14 at 11:00 AM ET, which will be available via live audio webcast on the FibroGen website. The chat will also have a 30-day replay option.

FibroGen focuses on developing innovative therapeutics, including roxadustat for anemia related to chronic kidney disease and other conditions, and pamrevlumab for multiple serious illnesses.