FibroGen, Inc.
409 Illinois Street
San Francisco
California
94158
United States
Tel: 415-978-1200
Website: http://www.fibrogen.com/
Email: info@fibrogen.com
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.
169 articles with FibroGen, Inc.
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FibroGen and HiFiBiO Announce Transformative Partnership to Advance Next-Generation Therapies for Patients with Cancer and Autoimmune Disease
6/17/2021
FibroGen, Inc. and HiFiBiO Therapeutics, a private, multinational clinical-stage biotherapeutics company with expertise in immune modulation and single cell science announced a partnership covering three HiFiBiO programs.
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Pamrevlumab Included in Pancreatic Cancer Action Network’s Adaptive Clinical Trial Platform
6/16/2021
FibroGen, Inc. (NASDAQ: FGEN) announced activation of an experimental arm in the Pancreatic Cancer Action Network's (PanCAN) Precision PromiseSM adaptive trial platform evaluating pamrevlumab [and standard of care] for patients with metastatic pancreatic cancer.
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FibroGen to Present at Upcoming Investor Conferences - May 27, 2021
5/27/2021
FibroGen, Inc. announced that Enrique Conterno, Chief Executive Officer, will participate in fireside chats at the following virtual healthcare conferences
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FibroGen Reports First Quarter 2021 Financial Results
5/10/2021
FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the first quarter 2021 and provided an update on the Company’s recent developments.
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FibroGen to Report First Quarter 2021 Financial Results
5/3/2021
FibroGen, Inc. will announce its first quarter 2021 financial results on Monday, May 10 after the market close.
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FibroGen to Present at Upcoming Investor Conference - Apr 28, 2021
4/28/2021
FibroGen, Inc. announced that Enrique Conterno, Chief Executive Officer, will participate in a fireside chat at the BofA Securities 2021 Virtual Health Care Conference on May 13, 2021 at 5:00 PM Eastern Time.
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FibroGen Receives Rare Pediatric Disease Designation from the U.S. FDA for Pamrevlumab for the Treatment of Duchenne Muscular Dystrophy
4/15/2021
FibroGen, Inc. (NASDAQ: FGEN) announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for the company’s anti-CTGF antibody, pamrevlumab, for the treatment of patients with Duchenne muscular dystrophy (DMD)
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FibroGen Receives Fast Track Designation from the U.S. FDA for Pamrevlumab for the Treatment of Duchenne Muscular Dystrophy
4/12/2021
FibroGen, Inc. (NASDAQ: FGEN) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s anti-CTGF antibody, pamrevlumab, for the treatment of patients with Duchenne muscular dystrophy (DMD)
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Shares of FibroGen were crashing this morning after the company unsuccessfully attempted to express confidence in the benefit/risk profile of its anemia drug, Roxadustat.
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FibroGen Provides Additional Information on Roxadustat
4/6/2021
FibroGen, Inc. provided clarification of certain prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia of chronic kidney disease.
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FibroGen Announces FDA Advisory Committee to Review Roxadustat New Drug Application Tentatively Scheduled for July 15, 2021
4/6/2021
FibroGen, Inc. (NASDAQ: FGEN) announced that the U.S. Food and Drug Administration (FDA) has informed the Company late today it has tentatively scheduled a Cardiovascular and Renal Drug Advisory Committee (CRDAC) on July 15, 2021 to review the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD) in both dialysis-dependent and non-dialysis-dependent patients.
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FibroGen Initiates LELANTOS-2 – Second Phase 3 Clinical Study of Pamrevlumab for the Treatment of Duchenne Muscular Dystrophy
3/16/2021
FibroGen, Inc. announced the initiation of LELANTOS-2, a Phase 3, randomized, double-blind, placebo-controlled trial of pamrevlumab or placebo in combination with systemic corticosteroids in patients with ambulatory Duchenne muscular dystrophy.
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The second half of March is a busy month for the U.S. Food and Drug Administration (FDA), with quite a few PDUFA dates scheduled. Here’s a look at this week’s target action dates.
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The U.S. FDA has decided to put together an advisory committee meeting of outside experts to review a New Drug Application for roxadustat, FibroGen and its partner AstraZeneca’s investigational anemia therapy.
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FibroGen Reports Fourth Quarter and Full Year 2020 Financial Results
3/1/2021
FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the fourth quarter and full year 2020 and provided an update on the company’s recent developments.
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FibroGen to Report Fourth Quarter and Full Year 2020 Financial Results
2/18/2021
FibroGen, Inc. will announce its fourth quarter and full year 2020 financial results on Monday, March 1 after the market close. FibroGen will also conduct a conference call on that day at 5:00 p.m. ET with the investment community to further detail the company's corporate and financial performance.
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FibroGen to Present at Upcoming Investor Conferences - Feb 12, 2021
2/12/2021
FibroGen, Inc. announced that Enrique Conterno, Chief Executive Officer, will participate in fireside chats at the following virtual healthcare conferences
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FibroGen Provides Regulatory Update on Roxadustat
12/18/2020
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.
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FibroGen to Present Safety and Efficacy Analyses from Roxadustat Global Phase 3 Program at American Society of Hematology Annual Meeting
12/2/2020
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
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FibroGen Announces Retirement of K. Peony Yu, M.D., and Appointment of Mark Eisner, M.D., M.P.H. as Chief Medical Officer
12/1/2020
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