Fibrogen Inc Stock Price, News & Analysis

FibroGen (NASDAQ: FGEN) announced that the FDA has scheduled a Cardiovascular and Renal Drug Advisory Committee meeting on July 15, 2021, to review the New Drug Application for roxadustat, aimed at treating anemia of chronic kidney disease (CKD) in all patients. This NDA submission is supported by positive Phase 3 results from over 8,000 patients. Roxadustat is already approved in China and Japan. It works by promoting red blood cell production and is also in development for anemia related to myelodysplastic syndromes and chemotherapy.

FibroGen, Inc. (Nasdaq: FGEN) has clarified certain cardiovascular safety analyses of its drug Roxadustat for treating anemia of chronic kidney disease (CKD). CEO Enrique Conterno emphasized confidence in Roxadustat's benefit-risk profile despite post-hoc changes in study stratification factors. The FDA Advisory Committee meeting is upcoming, with no changes to efficacy results. Roxadustat has been launched in China and Japan, and a marketing application is under review in Europe. The company is committed to an internal review to prevent future discrepancies.

FibroGen initiated LELANTOS-2, a Phase 3 clinical trial of pamrevlumab for Duchenne muscular dystrophy (DMD). This global study will assess pamrevlumab's impact on muscle function in approximately 70 patients aged 6 to 12 over 52 weeks, comparing it to a placebo. The primary endpoint is measured using the North Star Ambulatory Assessment. The trial highlights FibroGen's commitment to addressing the unmet medical needs in DMD, a condition characterized by rapid progression and severe complications.

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.