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 leading biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapeutics aimed at addressing serious unmet medical needs. The company has a strong research foundation in fibrosis and hypoxia-inducible factor (HIF) biology, leading to diverse clinical programs targeting multiple therapeutic areas.
Key Products and Programs
- Roxadustat (FG-4592): An oral small molecule inhibitor of HIF prolyl hydroxylases (HIF-PHs), Roxadustat is in phase 3 clinical development for treating anemia in chronic kidney disease (CKD). It is approved in China, Europe, Japan, and numerous other countries for treating anemia related to CKD in both dialysis and non-dialysis patients. Roxadustat also has a submitted application for chemotherapy-induced anemia (CIA) in China.
- FG-3019 (Pamrevlumab): A monoclonal antibody currently in phase 2 and 3 clinical trials aimed at idiopathic pulmonary fibrosis (IPF), pancreatic cancer, and liver fibrosis. Pamrevlumab has received orphan drug designation and fast track designation from the FDA for locally advanced unresectable pancreatic cancer (LAPC).
- FG-3246 (FOR46): This first-in-class antibody-drug conjugate (ADC) is in phase 1 clinical development for metastatic castration-resistant prostate cancer (mCRPC). FG-3246 targets CD46, a cell surface receptor highly expressed in prostate cancer and other tumor types.
- FG-3175: An investigational CCR8-targeted antibody designed to treat solid tumors infiltrated by CCR8-positive T regulatory cells (Tregs). The company plans to submit an IND application for FG-3175 in 2025.
Recent Achievements
In 2023, FibroGen reported encouraging financial results and significant progress in its clinical programs. The company has a robust pipeline of late-stage trials, including two for pancreatic cancer and a planned phase 2 trial for mCRPC. Financially, the company boasts a strong balance sheet with a cash runway extending into 2026, bolstered by successful corporate cost reduction initiatives. Partnerships with Astellas and AstraZeneca support the global development and commercialization of Roxadustat, while collaborations with Just-Evotec Biologics aid in manufacturing clinical trial materials.
Collaborations and Market Presence
FibroGen generates the majority of its revenue from collaboration agreements, primarily in Europe, followed by Japan. Key collaborations include Astellas and AstraZeneca, focusing on the development and commercialization of Roxadustat across various regions, including Japan, Europe, China, and others. FibroGen continues to seek partners with complementary research, development, and marketing capabilities to enhance its product development and commercialization efforts.
Investor and Media Relations
For the latest updates, financial results, conference calls, and webcasts, investors and interested parties are encouraged to visit the company’s website.
FibroGen, Inc. (NASDAQ: FGEN) will release its first quarter 2023 financial results on May 8, 2023, following the market's close. A conference call is scheduled for 5:00 PM ET on the same day to discuss the company's performance with investors. FibroGen specializes in biopharmaceuticals, focusing on developing innovative therapeutics, including Pamrevlumab for treating idiopathic pulmonary fibrosis and various cancers, and Roxadustat, which is approved for managing anemia due to chronic kidney disease. Roxadustat is currently in Phase 3 clinical trials for additional anemia indications. Interested parties can access the conference call through the company's Investor Relations page or via phone. A replay will be provided afterward.
Foresee Pharmaceuticals announced the appointment of Dr. Bassem Elmankabadi as Senior Vice President of Clinical Development on April 17, 2023. Dr. Elmankabadi brings over 17 years of clinical experience, previously holding leadership roles at Amgen (NASDAQ: AMGN) and FibroGen (NASDAQ: FGEN). His experience includes negotiating four Clinical Development Plans for Phase 2 and 3 studies for the company's drugs, Cudetaxestat and Pamrevlumab. Dr. Elmankabadi's background includes surgical leadership and clinical instruction at UCLA. Foresee Pharmaceuticals focuses on innovative therapies, with key products including CAMCEVI for advanced prostate cancer, approved in the U.S., Canada, and EU, as well as other promising candidates in clinical development.
FAQ
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What is FG-3246?
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