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.
The news archive for FibroGen, Inc. (FGEN) captures the company’s transition to Kyntra Bio, Inc. and its focus on oncology, anemia, and rare disease programs. Company press releases document the formal name change to Kyntra Bio through a Certificate of Amendment filed in Delaware and the shift of its Nasdaq listing from the ticker FGEN to KYNB as of January 8, 2026.
News items highlight Kyntra Bio’s biopharmaceutical pipeline, including updates on roxadustat, an oral HIF-PH inhibitor approved in China, Europe, Japan, and numerous other countries for anemia of chronic kidney disease in adults on dialysis and not on dialysis. Releases also cover regulatory milestones such as FDA Orphan Drug Designation for roxadustat in myelodysplastic syndromes and plans for a pivotal Phase 3 trial in anemia associated with lower-risk MDS and high transfusion burden in the United States.
Investors can review announcements on FG-3246, a potential first-in-class CD46-targeting antibody-drug conjugate in development for metastatic castration-resistant prostate cancer, and FG-3180, a related CD46-targeted PET imaging agent being evaluated as a companion diagnostic. The news flow includes trial initiations, investigator-sponsored studies, and planned data readouts.
Additional coverage details corporate and financial developments, such as the completed sale of FibroGen China to AstraZeneca, repayment of a senior secured term loan, and commentary on the company’s cash runway. This page serves as a historical record of FGEN-labeled announcements, including the period before and during the company’s transformation into Kyntra Bio.
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.
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.