Fibrogen Inc Stock Price, News & Analysis

FibroGen reported significant growth in Q3 2021, with total revenue reaching $156 million, a substantial increase from $44 million in Q3 2020. This surge includes a $120 million milestone payment from Astellas following EU approval of roxadustat for CKD-related anemia. The net income also rose to $49.8 million or $0.54 per share. Additionally, net product revenue from roxadustat sales in China totaled $13.4 million for the quarter, contributing to overall sales of $57.8 million.

FibroGen, Inc. (NASDAQ: FGEN) announced that CEO Enrique Conterno will participate in two upcoming healthcare conferences. The first is the Stifel 2021 Virtual Healthcare Conference on November 16, 2021, at 4:40 PM EST, followed by the Jefferies London Healthcare Conference on November 18, 2021, at 3:00 AM EST. An audio webcast will be available on the company's Investor webpage, with replays accessible for 30 days. FibroGen focuses on developing first-in-class therapeutics, including roxadustat for anemia and pamrevlumab for various disorders.

FibroGen, Inc. (NASDAQ: FGEN) will release its Q3 2021 financial results on November 9, 2021, after market close. A conference call for investors will follow at 5:00 p.m. ET to discuss the company's financial performance.

Participants can access the live audio webcast on FibroGen's website. Dial-in numbers for the call are available for both U.S./Canada and international callers. A replay of the call will be accessible shortly after the event for seven days.

FibroGen (NASDAQ: FGEN) has announced that 18 presentations from its global Phase 3 roxadustat clinical program will be featured at the American Society of Nephrology Kidney Week 2021, held virtually from November 4-7, 2021. Key highlights include 11 presentations focusing on roxadustat's efficacy in treating anemia related to chronic kidney disease (CKD) and 7 on CKD anemia epidemiology, underscoring its medical need. Roxadustat, an oral medication, is currently approved in several regions for CKD-related anemia and is in further regulatory reviews.

FibroGen announced positive topline results from the WHITNEY Phase 2 clinical study of roxadustat for treating chemotherapy-induced anemia (CIA). The study met its primary endpoint: maximum change in hemoglobin within 16 weeks without red blood cell transfusion. Ninety-two patients with non-myeloid malignancies participated, receiving doses of 2.0 mg/kg or 2.5 mg/kg of roxadustat three times per week. The drug was generally well tolerated, with no significant differences in adverse events based on dosage. Full results will be presented at a medical meeting later this year.

FibroGen and Astellas Pharma announced the European Commission's approval of EVRENZO™ (roxadustat) for treating anemia associated with chronic kidney disease (CKD) in adults. This marks the first oral HIF-PH inhibitor available in the EU. The approval, which follows a positive opinion from the European Medicines Agency, is based on Phase 3 clinical trials involving 9,600 patients, demonstrating efficacy in achieving target hemoglobin levels. The approval triggers a $120 million milestone payment from Astellas to FibroGen, alongside future royalties based on European sales.

Astellas Pharma and FibroGen announced the European Commission's approval of EVRENZO™ (roxadustat) for treating symptomatic anemia linked to chronic kidney disease (CKD) in adults. This makes roxadustat the first oral HIF-PH inhibitor available in the EU, enhancing treatment options for CKD patients. The approval follows a positive opinion from the EMA and triggers a $120 million milestone payment from Astellas to FibroGen. The comprehensive Phase 3 program involved 9,600 patients and demonstrated efficacy in maintaining target hemoglobin levels.

FibroGen, Inc. (NASDAQ: FGEN) announced the retirement of Pat Cotroneo, Chief Financial Officer, effective September 6, 2021. He will serve as Executive Advisor until March 31, 2022, ensuring a smooth transition. Juan Graham will take over as CFO from September 7, 2021, bringing nearly 20 years of biopharmaceutical financial management experience. CEO Enrique Conterno highlighted Graham's leadership as vital during a critical phase for the company, which is advancing clinical milestones in its therapeutic pipeline.

FibroGen, Inc. (NASDAQ: FGEN) announced that the FDA has issued a complete response letter for its New Drug Application (NDA) of roxadustat aimed at treating anemia of chronic kidney disease (CKD). The FDA's letter indicates that the NDA will not be approved in its current form and requires further clinical studies. Although roxadustat is already approved in several countries, the delay in U.S. approval is disappointing for patients and stakeholders. Discussions with AstraZeneca regarding next steps are expected as the company focuses on future clinical studies.