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.
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.
FibroGen, Inc. (NASDAQ: FGEN) has successfully completed enrollment of 372 patients in its Phase 3 clinical trial, ZEPHYRUS-2, targeting idiopathic pulmonary fibrosis (IPF). This trial, which is randomized, double-blind, and placebo-controlled, aims to assess the efficacy and safety of pamrevlumab over a 48-week period, with top-line results expected in mid-2024. The company's Chief Medical Officer expressed optimism for new treatment options for IPF patients. FibroGen is also conducting another Phase 3 trial, ZEPHYRUS-1, with data anticipated in mid-2023, furthering their commitment to addressing unmet medical needs in fibrotic diseases.
FibroGen reported 2022 total revenue of $140.7 million, down from $235.3 million in 2021. Fourth-quarter revenue was $34.4 million, compared to $16.5 million year-over-year. Roxadustat sales in China reached $82.9 million, a 74% increase from 2021, with total sales in the fourth quarter at $53.1 million, up 328%. The company anticipates key trial data releases in 2023 for treatments, including pamrevlumab and roxadustat. FibroGen has $442.7 million in cash and equivalents, sufficient to fund operations through mid-2024 without additional financing.
FibroGen (NASDAQ: FGEN) announced that Mark Eisner, M.D., M.P.H., Chief Medical Officer, will participate in a panel discussion at Cowen’s 43rd Annual Health Care Conference held in Boston from March 5-8, 2023. The panel will focus on Respiratory/Infections and is scheduled for March 8, 2023, at 10:30 AM Eastern Time. Investors can access a live audio webcast on the FibroGen Investor webpage, with a replay available for approximately 30 days. FibroGen continues to innovate in biopharmaceuticals, focusing on therapies for conditions such as idiopathic pulmonary fibrosis and anemia associated with myelodysplastic syndromes.
FibroGen, Inc. (NASDAQ: FGEN) will release its fourth quarter and full year 2022 financial results on February 27, 2023, after market close. A conference call is scheduled for the same day at 5:00 PM Eastern Time to discuss the company’s corporate and financial performance. FibroGen focuses on developing innovative therapeutics, including Pamrevlumab for idiopathic pulmonary fibrosis and Roxadustat for anemia in chronic kidney disease. Roxadustat is already approved in several regions, while ongoing clinical trials aim to expand its applications. Investors can access the call via the company’s website.
FibroGen announced that CEO Enrique Conterno will participate in a virtual fireside chat at the SVB Securities Global Biopharma Conference on February 16, 2023, at 3:40 PM ET. The event's live audio webcast will be accessible on the FibroGen Investor webpage, with a replay available for about 30 days. FibroGen focuses on developing first-in-class therapeutics, including Pamrevlumab, for treating conditions like idiopathic pulmonary fibrosis and pancreatic cancer. Their Roxadustat is already approved for treating anemia in CKD patients and is in further clinical trials.
FibroGen, Inc. (NASDAQ: FGEN) will have CEO Enrique Conterno participate in a fireside chat at the Bank of America 2022 Biotech SMID Cap Virtual Conference on December 8 at 1:05 PM Eastern Time. Investors can access a live audio webcast on the company's Investors webpage, with a replay available for 30 days. FibroGen focuses on developing first-in-class therapeutics, including treatments for idiopathic pulmonary fibrosis, pancreatic cancer, and anemia. Notably, Roxadustat is approved in multiple countries for CKD anemia and is in advanced trials for related conditions.
FibroGen (FGEN) reported a third-quarter 2022 net loss of $91.7 million, translating to $0.98 per share, compared to a net income of $49.8 million during the same period last year. Total revenue fell to $15.7 million from $156.0 million, impacted by a 2021 milestone payment from Astellas. However, the company secured $50 million through a non-dilutive royalty monetization deal with NovaQuest, backed by 22.5% of roxadustat royalty revenue. Roxadustat sales in China grew 29% to $17.4 million, while the MATTERHORN Phase 3 study for MDS has completed enrollment, with topline data expected in 1H 2023.
FibroGen, Inc. (FGEN) announced a strategic financing partnership with NovaQuest Capital Management, securing $50 million in non-dilutive capital. This funding aims to support the company's growth and innovation, particularly for EVRENZO™ and its late-stage pipeline. FibroGen will allocate part of the proceeds towards its pamrevlumab program, anticipating multiple pivotal Phase 3 readouts in 2023 and 2024. The agreement grants NovaQuest 22.5% of future EVRENZO™ royalties in certain regions until capped payments are reached, after which FibroGen retains full royalty rights.
FibroGen (NASDAQ: FGEN) announces that CEO Enrique Conterno will participate in a fireside chat at the Stifel 2022 Healthcare Conference in New York on November 15, 2022, at 1:50 PM ET. A live audio webcast will be accessible via the Investors section of the FibroGen website, with a replay available for 30 days.
FibroGen is a biopharmaceutical company focused on innovative therapies, including the clinical development of Pamrevlumab for treating various conditions and Roxadustat, which is approved internationally for anemia in CKD patients.
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