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About FibroGen, Inc.
FibroGen, Inc., headquartered in San Francisco, with subsidiary offices in Beijing and Shanghai, is a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF), connective tissue growth factor (CTGF) biology, and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat, the company's most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase activity, completing worldwide Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD), with a New Drug Application (NDA) currently under review in China by the State Drug Administration (SDA). Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (MDS). Pamrevlumab, an anti-CTGF human monoclonal antibody, is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). FibroGen is also developing a biosynthetic cornea in China. For more information, please visit www.fibrogen.com.
152 articles with FibroGen, Inc.
FibroGen, Inc. announced that the U.S. Food and Drug Administration has extended the review period of the New Drug Application for roxadustat for the treatment of anemia of chronic kidney disease by three months.
FibroGen to Present Safety and Efficacy Analyses from Roxadustat Global Phase 3 Program at American Society of Hematology Annual Meeting
New data show safety and efficacy of roxadustat in treating anemia secondary to lower-risk myelodysplastic syndrome s (MDS) regardless of ring sideroblast (RS) or baseline e rythro poietin level Multiple analyses evaluate cardiovascular safety and efficacy of roxadustat in patients with anemia of chronic kidney disease (CKD ) regardless of dialysis status
FibroGen Announces Retirement of K. Peony Yu, M.D., and Appointment of Mark Eisner, M.D., M.P.H. as Chief Medical Officer
FibroGen, Inc. (NASDAQ: FGEN) today announced the retirement of K. Peony Yu, M.D., Chief Medical Officer, and appointment of Mark Eisner, M.D., M.P.H. in that role. Dr. Yu will continue as Chief Medical Officer through December 20, 2020, the roxadustat PDUFA date, and will remain with FibroGen through March 15, 2021 serving as Executive Advisor to the CEO to support the transition. Dr. Yu joined FibroGen in 2008 and has provided key leadership
Astellas Receives Approval of EVRENZO® (roxadustat) in Japan for the Treatment of Anemia of Chronic Kidney Disease
FibroGen, Inc. (Nasdaq: FGEN, CEO: Enrique Conterno, “FibroGen”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved EVRENZO ® (roxadustat) for the treatment of anemia of chronic kidney disease (CKD) in adult patients not on dialysis. This marks the second approval in Japan for roxadustat through the Astellas and
FibroGen, Inc. announced that Enrique Conterno, Chief Executive Officer, will participate in fireside chats at the following healthcare conferences
“I am pleased with our progress with roxadustat across a number of fronts; including engagement with the FDA, commercial preparations in the U.S., and our impressive sales results in China.” said Enrique Conterno, Chief Executive Officer, FibroGen.
FibroGen presented data from two pooled analyses from its roxadustat global Phase III development program this weekend at the American Society of Nephrology Kidney Week 2020 Reimagined conference.
10/26/2020It was another busy week for clinical trial updates and news. Here’s a look.
FibroGen Presents Late-Breaker Abstract Results on Associations between Hemoglobin Levels and Cardiovascular Outcomes in Roxadustat-Treated Patients with Anemia of Chronic Kidney Disease (CKD)
In non-dialysis and dialysis-dependent CKD patients, Major Adverse Cardiovascular Event (MACE) and MACE+ incidence rates were lowest when patients achieved hemoglobin levels ≥ 1 0 g/dL Two analyses o f pooled data from the roxadustat global Phase 3 development program t o be presented during the American Society of Nephrology Kidney Week 2020 Reimagined
New Roxadustat Data in Anemia of Chronic Kidney Disease to be Released at ASN Kidney Week 2020 Reimagined
42 abstracts featuring additional insights into roxadustat and anemia of chronic kidney disease to be presented
FibroGen to Present New Efficacy and Safety Analyses from Roxadustat Global Phase 3 Program at American Society of Nephrology Kidney Week 2020 Reimagined
Late-breaking abstracts explore cardiovascularoutcomes of patients with anemia in chronic kidney disease(CKD) treated with roxadustat, including associations with achieved hemoglobin levels and risk of Major Adverse Cardiovascular Events (MACE) and MACE+
New Ventures Funds has launched a new corporate brand identity and changed its name to Scientia Ventures. The new website for the firm can be found at: www.scientiavc.com.
FibroGen, Inc. announced the appointment of Percy Carter, MBA, PhD, to the newly-created position of Chief Scientific Officer, where he will lead FibroGen’s research efforts, leveraging more than 20 years of global biopharmaceutical leadership and experience.
FibroGen, Inc. (NASDAQ: FGEN) today announced that Enrique Conterno, Chief Executive Officer, will participate in fireside chats at the following virtual healthcare conferences: Citigroup 15th Annual BioPharma Conference on September 9, 2020 at 2:25 PM Eastern Time Morgan Stanley 18 th Annual Global Healthcare Conference on September 16, 2020 at 3:30 PM Eastern Time A live audio webcast will be available on the “Events & Presentation
FibroGen Announces First Patient Enrolled in Pamrevlumab Phase 3 Clinical Trial in Patients with Duchenne Muscular Dystrophy
FibroGen, Inc. (NASDAQ: FGEN) announced the initiation of LELANTOS, a Phase 3, randomized, double-blind, placebo-controlled trial of pamrevlumab or placebo in combination with systemic corticosteroids in patients with non-ambulatory Duchenne muscular dystrophy (DMD). The primary objective of this global study is to evaluate the effect of pamrevlumab on muscle function in patients with DMD. Approximately 90 patients will be randomized 1:1 to rec
FibroGen, Inc. reported financial results for the second quarter of 2020 and provided an update on the company’s recent developments.
Appoints Ben Cravatt, Ph.D., Professor and the Norton B. Gilula Chair of Chemical Biology in the Department of Chemistry at The Scripps Research Institute
FibroGen, Inc. will announce its second quarter 2020 financial results on Thursday, August 6 after the market close.
FibroGen Announces First Patient Enrolled in Pamrevlumab Clinical Trial in Patients Hospitalized in U.S. with Acute COVID-19
FibroGen, Inc. announced the initiation of a randomized, double-blind, placebo-controlled Phase 2 Study investigating the efficacy and safety of pamrevlumab in hospitalized patients with acute coronavirus 2019 infection.
FibroGen, Inc. announced the appointment of Thane Wettig to the newly-created position of Chief Commercial Officer, where he will lead FibroGen’s commercialization efforts, leveraging more than 30 years of global biopharmaceutical leadership and experience.