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) has successfully completed the enrollment of 356 patients in the Phase 3 clinical trial ZEPHYRUS-1, aimed at evaluating pamrevlumab for treating idiopathic pulmonary fibrosis (IPF). This study is double-blind and placebo-controlled, focusing on the change in forced vital capacity (FVC) as the primary endpoint. Topline data is expected in mid-2023. Pamrevlumab is a first-in-class antibody that inhibits connective tissue growth factor (CTGF) and has received Orphan Drug and Fast Track designations from the FDA for IPF, among other indications.
FibroGen, Inc. (NASDAQ: FGEN) reported a revenue increase from $176.3 million in 2020 to $235.3 million in 2021. The company completed the enrollment for the LAPIS Phase 3 study in pancreatic cancer and the LELANTOS-1 Phase 3 study in Duchenne muscular dystrophy. FibroGen's net loss widened to $134.1 million in Q4 2021 from $58.6 million the previous year. Roxadustat achieved $186.1 million in total sales in China for 2021, up from $72.5 million in 2020. The company plans to reduce projected expenses by $100 million annually over the next three years.
FibroGen, Inc. (NASDAQ: FGEN) will announce its fourth quarter and full year 2021 financial results on February 28, 2022, after market close. A conference call with investors is scheduled for the same day at 5:00 p.m. ET. This call will provide insights into the company’s corporate and financial performance.
Investors can access the call via the FibroGen website, with a replay available for 7 days post-call. FibroGen focuses on developing therapeutics for unmet medical needs, including treatments for anemia in chronic kidney disease and other conditions.
FibroGen, Inc. (NASDAQ: FGEN) announced that CEO Enrique Conterno will participate in a fireside chat at the SVB Leerink 11th Annual Global Healthcare Conference on February 18, 2022, at 3:40pm EST. The event's audio webcast will be accessible on the FibroGen Investor webpage, with a replay available for 30 days.
FibroGen focuses on developing innovative therapeutics, including roxadustat for various anemias and pamrevlumab for conditions like idiopathic pulmonary fibrosis and pancreatic cancer. The company has expanded into immuno-oncology and autoimmune research.
SAN FRANCISCO, Jan. 04, 2022 (GLOBE NEWSWIRE) -- FibroGen (NASDAQ: FGEN) announced that CEO Enrique Conterno will participate in a fireside chat at the H.C. Wainwright Bioconnect Virtual Conference from January 10-13. The session will be available on-demand starting January 10 at 7:00am EST.
Listeners can access the audio webcast via the 'Events & Presentations' section on FibroGen's Investor webpage, with a replay available for 30 days. FibroGen is focused on first-in-class therapeutics, including the development of roxadustat and pamrevlumab for various medical conditions.
FibroGen (FGEN) has extended its partnership with HiFiBiO Therapeutics by exercising an exclusive license for the anti-CCR8 monoclonal antibody program, HFB1011. This agreement involves a $35 million upfront payment plus potential milestones and royalty payments based on net sales. FibroGen gains exclusive global rights to develop products from this program, which targets CCR8, a receptor implicated in tumor immune suppression. The HFB1011 development candidate is expected to enter clinical trials in 2023, reinforcing FibroGen's focus on expanding its immuno-oncology pipeline.
FibroGen reported significant growth in Q3 2021, with total revenue reaching $156 million, a substantial increase from $44 million in Q3 2020. This surge includes a $120 million milestone payment from Astellas following EU approval of roxadustat for CKD-related anemia. The net income also rose to $49.8 million or $0.54 per share. Additionally, net product revenue from roxadustat sales in China totaled $13.4 million for the quarter, contributing to overall sales of $57.8 million.
FibroGen, Inc. (NASDAQ: FGEN) announced that CEO Enrique Conterno will participate in two upcoming healthcare conferences. The first is the Stifel 2021 Virtual Healthcare Conference on November 16, 2021, at 4:40 PM EST, followed by the Jefferies London Healthcare Conference on November 18, 2021, at 3:00 AM EST. An audio webcast will be available on the company's Investor webpage, with replays accessible for 30 days. FibroGen focuses on developing first-in-class therapeutics, including roxadustat for anemia and pamrevlumab for various disorders.
FibroGen, Inc. (NASDAQ: FGEN) will release its Q3 2021 financial results on November 9, 2021, after market close. A conference call for investors will follow at 5:00 p.m. ET to discuss the company's financial performance.
Participants can access the live audio webcast on FibroGen's website. Dial-in numbers for the call are available for both U.S./Canada and international callers. A replay of the call will be accessible shortly after the event for seven days.
FibroGen (NASDAQ: FGEN) has announced that 18 presentations from its global Phase 3 roxadustat clinical program will be featured at the American Society of Nephrology Kidney Week 2021, held virtually from November 4-7, 2021. Key highlights include 11 presentations focusing on roxadustat's efficacy in treating anemia related to chronic kidney disease (CKD) and 7 on CKD anemia epidemiology, underscoring its medical need. Roxadustat, an oral medication, is currently approved in several regions for CKD-related anemia and is in further regulatory reviews.