Fibrogen Inc Stock Price, News & Analysis

FibroGen, Inc. (NASDAQ: FGEN) will announce its Q1 2021 financial results on May 10, after market close. A conference call will follow at 5:00 p.m. ET to discuss the company's performance with investors. Interested parties can access the audio webcast via FibroGen's website and are encouraged to join 15 minutes early. The company is focused on innovative therapies, including the development of roxadustat for anemia related to chronic kidney disease and other conditions, as well as pamrevlumab for various serious diseases.

FibroGen, Inc. (NASDAQ: FGEN) announced CEO Enrique Conterno will participate in a fireside chat at the BofA Securities 2021 Virtual Health Care Conference on May 13, 2021, at 5:00 PM Eastern Time. A live audio webcast will be available on the company’s investor webpage.

FibroGen is a biopharmaceutical company focused on developing innovative therapeutics, including roxadustat for anemia related to chronic kidney disease and other conditions, and pamrevlumab for various cancers and diseases.

FibroGen has received Rare Pediatric Disease Designation from the FDA for its anti-CTGF antibody, pamrevlumab, aimed at treating Duchenne muscular dystrophy (DMD). The drug has also been granted Fast Track designation and is undergoing evaluation in two Phase 3 clinical trials. The FDA's designation highlights the unmet medical needs of pediatric patients with DMD, which affects roughly 1 in 5,000 newborn boys. If approved, pamrevlumab could qualify FibroGen for a Priority Review Voucher, enhancing its future drug approval processes.

FibroGen has received FDA Fast Track designation for its anti-CTGF antibody, pamrevlumab, aimed at treating Duchenne muscular dystrophy (DMD). This designation, based on Phase 2 clinical data from non-ambulatory patients, acknowledges the unmet medical need for DMD therapies. Pamrevlumab is also in Phase 3 trials for DMD and other conditions. Approximately 20,000 children worldwide are diagnosed with DMD annually, highlighting the potential impact of this treatment.

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.