Fibrogen Inc Stock Price, News & Analysis

FibroGen announced that CEO Enrique Conterno will participate in two upcoming virtual healthcare conferences. The events include the 10th Annual SVB Leerink Global Healthcare Conference on February 25, 2021, at 3:40 PM ET and the Cowen 41st Annual Health Care Conference on March 2, 2021, at 12:50 PM ET. Interested parties can access a live audio webcast of the discussions in the “Events & Presentations” section of the FibroGen Investor webpage at www.fibrogen.com. A replay will also be made available.

FibroGen (FGEN) announced the dosing of the first patient in the ZEPHYRUS-2 Phase 3 clinical trial for pamrevlumab, targeting idiopathic pulmonary fibrosis (IPF), a severe lung disease. This study will assess efficacy and safety over 52 weeks in patients who previously used other therapies. Key endpoints include forced vital capacity (FVC) changes and patient-reported outcomes, with expectations to enroll around 340 subjects. Pamrevlumab has shown promise in earlier trials, highlighting its potential for disease modification in IPF, contributing to FibroGen's commitment to unmet medical needs.

FibroGen, Inc. (Nasdaq: FGEN) announced that the FDA has extended the review period for roxadustat's NDA for anemia of chronic kidney disease by three months, setting a new PDUFA date of March 20, 2021. The extension is due to additional analyses being submitted regarding existing clinical data. Roxadustat, accepted for review as the first HIF-PH inhibitor, shows promise based on a global Phase 3 program involving over 8,000 patients. The company emphasizes the unmet medical need for effective CKD anemia treatments.

FibroGen and AstraZeneca announced promising data on roxadustat for treating anemia in patients with lower-risk myelodysplastic syndromes (MDS). The findings show that the drug is effective regardless of ring sideroblast status or baseline erythropoietin levels, with 55% of MDS-RS- patients achieving transfusion independence for ≥ 8 weeks. The results will be presented at the upcoming ASH Annual Meeting, emphasizing roxadustat's potential across diverse chronic kidney disease (CKD) patients. The study is ongoing and further data will be shared soon.

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.