FibroGen, Inc - FGEN STOCK NEWS

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.

FibroGen reported Q2 2021 financial results, highlighting a net loss of $134 million, or $1.45 per share, compared to a net loss of $85.3 million, or $0.95 per share in Q2 2020. The total revenue for the quarter amounted to $24.4 million, down from $42.9 million year-over-year. Roxadustat's net product revenue in China was $13.4 million, with total sales of $52.8 million. Positive developments include a favorable opinion from the CHMP concerning roxadustat for CKD. However, the FDA Advisory Committee recommended against its approval.

FibroGen, Inc. (NASDAQ: FGEN) will report its second quarter 2021 financial results on August 9, following the market's close. A conference call for investors is scheduled for that day at 5:00 p.m. ET, where the company will discuss its financial performance and corporate updates. Interested participants can access the call via a live audio webcast on the FibroGen website. Additionally, a replay of the conference call will be available for 30 days after the event.

Eluminex has licensed exclusive global rights from FibroGen for a biosynthetic cornea developed from recombinant human collagen. This clinical-stage asset aims to meet the significant demand for corneal grafts in treating blindness, particularly in China, where over 100,000 cases of corneal blindness occur annually. Eluminex will pay FibroGen $8 million upfront and up to $64 million in potential future payments. The biosynthetic cornea offers advantages over traditional donor tissues, including reduced risk of rejection and an abundant supply. Edward Holland joins Eluminex's Scientific Advisory Board.

The FDA's Cardiovascular and Renal Drugs Advisory Committee voted against the approval of roxadustat for treating anemia due to chronic kidney disease (CKD) in adults, citing concerns from a Phase 3 program involving over 8,000 patients. Despite this, the company remains hopeful, stating scientific evidence supports the drug's approval. Roxadustat is already approved in several countries and is the first of its kind under FDA review. Anemia associated with CKD affects about 20% of patients, increasing hospitalization and mortality risks.

FibroGen (NASDAQ: FGEN) appointed Dr. John Hunter as Chief Scientific Officer, tasked with advancing the company's research initiatives. Dr. Hunter brings over 20 years of experience in biopharmaceuticals, previously serving as Chief Executive & Scientific Officer at Keyhole Therapeutics and Chief Scientific Officer at Compugen. He has driven the strategic direction leading to multiple IND filings and clinical advancements. Under his leadership, FibroGen aims to push its late-stage programs towards commercialization while enhancing its early drug pipeline.

Astellas Pharma and FibroGen announced a positive opinion from the European Medicines Agency's CHMP for roxadustat, an oral treatment for anemia in adults with chronic kidney disease (CKD). This condition affects 1 in 10 globally, with many patients untreated. If approved by the European Commission, roxadustat will be the first HIF-PH inhibitor in Europe, providing a novel mechanism to increase hemoglobin levels. The positive opinion is based on a Phase 3 program involving 9,600 patients, showing efficacy and safety comparable to existing treatments.

Astellas Pharma and FibroGen announced a positive opinion from the European Medicines Agency's CHMP for roxadustat, aimed at treating symptomatic anemia in chronic kidney disease (CKD) patients. This potential approval would make roxadustat the first oral HIF-PH inhibitor in Europe. The CHMP's positive stance is based on a Phase 3 program involving 9,600 patients, demonstrating effectiveness in increasing hemoglobin levels and a safety profile comparable to existing treatments. The European Commission will review the opinion within 67 days for a final decision.