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 announced the retirement of Dr. K. Peony Yu as Chief Medical Officer, effective December 20, 2020, just ahead of the PDUFA date for roxadustat. Dr. Yu will assist in the transition as Executive Advisor to the CEO until March 15, 2021. Mark Eisner, with over 30 years of experience, will step in as the new Chief Medical Officer on December 21, 2020, overseeing global clinical development. This leadership change comes as the company aims to accelerate its development pipeline and achieve significant clinical milestones.
Astellas Pharma and FibroGen announced that Japan's Ministry of Health has approved EVRENZO (roxadustat) for treating anemia of chronic kidney disease (CKD) in adults not on dialysis. This follows a previous approval for patients on dialysis. The approval is based on clinical studies involving over 500 patients, demonstrating non-inferiority to darbepoetin alfa. A $15 million milestone payment will be made by Astellas to FibroGen. Roxadustat is a first-in-class oral treatment that enhances hemoglobin levels by activating the body's natural response to low oxygen.
SAN FRANCISCO, Nov. 06, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced CEO Enrique Conterno will participate in fireside chats at two upcoming healthcare conferences:
- Stifel 2020 Virtual Healthcare Conference on November 17, 2020, at 1:20 PM ET
- Jefferies Virtual London Healthcare Conference on November 19, 2020, at 12:35 PM ET
Live webcasts will be available on FibroGen's Investor webpage, with replays accessible for 30 days. FibroGen focuses on developing therapeutics for unmet medical needs, including treatments for anemia and idiopathic pulmonary fibrosis.
FibroGen (NASDAQ:FGEN) reported Q3 2020 total revenue of $44.0 million, up from $33.2 million in Q3 2019, driven by strong roxadustat sales of $22.7 million in China. The company achieved a net income of $33.0 million or $0.36 per share, a significant recovery from a net loss of $49.4 million last year. FibroGen also amended its agreement with AstraZeneca to enhance profitability. Upcoming events include discussions on the U.S. NDA for roxadustat with a decision expected by December 20, 2020.
FibroGen, Inc. (NASDAQ: FGEN) will report its third quarter 2020 financial results on November 5, after market close. A conference call will be held at 5:00 p.m. ET to discuss corporate and financial performance. Investors can access the live audio webcast on the company's website. Roxadustat, a drug for anemia associated with chronic kidney disease, is highlighted, along with ongoing developments for related conditions. Pamrevlumab, another investigational therapy, is in clinical trials for multiple serious diseases.
FibroGen announced the results from two analyses of pooled data from the roxadustat global Phase 3 development program, which were presented at the ASN Kidney Week 2020. The analyses revealed that Major Adverse Cardiovascular Events (MACE) rates in chronic kidney disease (CKD) patients were highest when hemoglobin (Hb) was below 8 g/dL. Rates decreased as Hb increased and were lowest when Hb levels reached or exceeded 10 g/dL. This data supports roxadustat's efficacy and potential as a treatment for anemia in CKD patients.
FibroGen is set to present new findings on roxadustat at the ASN Kidney Week 2020, highlighting its efficacy in treating anemia in patients with chronic kidney disease (CKD). The studies will explore various patient demographics, including dialysis-dependent and non-dialysis-dependent groups, and will address the safety profile regarding cardiovascular risks and hospitalizations. The data suggests potential reductions in the need for red blood cell transfusions and emphasizes roxadustat's promise as a foundational treatment option for CKD-related anemia.
FibroGen, Inc. has appointed Percy Carter as the Chief Scientific Officer to enhance its research efforts. Dr. Carter brings over 20 years of biopharmaceutical experience, previously serving as Global Head of Discovery Sciences at Janssen. His background includes significant roles at Bristol-Myers Squibb and DuPont Pharmaceuticals, highlighting his leadership in drug discovery. CEO Enrique Conterno emphasized the importance of Dr. Carter's expertise in advancing FibroGen's unique therapeutic developments, particularly in hypoxia-inducible factor and connective tissue growth factor biology.
FibroGen, a biopharmaceutical company, announced CEO Enrique Conterno's participation in virtual healthcare conferences on September 9 and September 16, 2020. He will speak at the Citigroup 15th Annual BioPharma Conference at 2:25 PM ET and the Morgan Stanley 18th Annual Global Healthcare Conference at 3:30 PM ET. A live audio webcast can be accessed on the FibroGen Investor webpage, with replays available for 30 days. FibroGen focuses on developing innovative treatments for unmet medical needs, including roxadustat for chronic kidney disease anemia and pamrevlumab for various conditions.
FibroGen (NASDAQ: FGEN) has initiated the LELANTOS Phase 3 clinical trial to evaluate pamrevlumab in patients with non-ambulatory Duchenne muscular dystrophy (DMD). The study aims to assess muscle function improvement over 52 weeks in approximately 90 patients receiving pamrevlumab plus corticosteroids or placebo. Key endpoints include changes in upper limb performance and evaluations of pulmonary and cardiac function. This trial marks a significant milestone in FibroGen's DMD program and reflects the company's commitment to addressing this debilitating condition.