Welcome to our dedicated page for Fibrogen news (Ticker: FGEN), a resource for investors and traders seeking the latest updates and insights on Fibrogen stock.
FibroGen, now Kyntra Bio, reports biopharmaceutical developments centered on oncology, rare disease and anemia assets. Recurring updates cover FG-3246, a CD46-targeting antibody-drug conjugate in development for metastatic castration-resistant prostate cancer, and FG-3180, an associated CD46-targeted PET imaging agent. News also covers roxadustat, including its approvals for anemia in chronic kidney disease in multiple non-U.S. markets and its U.S. orphan drug designation for myelodysplastic syndromes.
Company updates also include financial results, conference presentations, regulatory communications, shareholder and governance matters, and corporate-status changes. Completed corporate actions include the sale of FibroGen China operations and the 2026 name and ticker transition from FibroGen and FGEN to Kyntra Bio and KYNB.
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.
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.