FibroGen, Inc - FGEN STOCK NEWS

FibroGen and AstraZeneca announced that the FDA's Cardiovascular and Renal Drugs Advisory Committee will review the new drug application for roxadustat. Although the companies have not received a meeting date, they remain committed to working with the FDA to expedite the drug's availability for patients with anemia of CKD. Roxadustat, already approved in China, Japan, and Chile, is the first HIF-PH inhibitor under review by the FDA. The drug has shown positive results in a Phase 3 program involving over 8,000 patients.

FibroGen reported Q4 2020 net sales of $29.2 million for roxadustat in China, contributing to full-year sales of $72.5 million. The FDA plans to hold an advisory meeting for the roxadustat NDA. Despite a net loss of $58.6 million in Q4 and $189.3 million for the year, company leadership remains confident in roxadustat’s efficacy, citing successful clinical programs. Cash reserves stand at $732.1 million. Future data releases from various studies are expected to impact FibroGen’s trajectory.

FibroGen, Inc. (NASDAQ: FGEN) is set to announce its fourth quarter and full year 2020 financial results on March 1 after market close. The company will hold a conference call at 5:00 p.m. ET to discuss its corporate and financial performance. Stakeholders can access the call via FibroGen's website or by phone. FibroGen specializes in developing therapeutics for conditions such as anemia related to chronic kidney disease and other serious diseases. Their lead product is roxadustat, currently in clinical development.

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.