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, Inc. (NASDAQ: FGEN) is a leading biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapeutics aimed at addressing serious unmet medical needs. The company has a strong research foundation in fibrosis and hypoxia-inducible factor (HIF) biology, leading to diverse clinical programs targeting multiple therapeutic areas.
Key Products and Programs
- Roxadustat (FG-4592): An oral small molecule inhibitor of HIF prolyl hydroxylases (HIF-PHs), Roxadustat is in phase 3 clinical development for treating anemia in chronic kidney disease (CKD). It is approved in China, Europe, Japan, and numerous other countries for treating anemia related to CKD in both dialysis and non-dialysis patients. Roxadustat also has a submitted application for chemotherapy-induced anemia (CIA) in China.
- FG-3019 (Pamrevlumab): A monoclonal antibody currently in phase 2 and 3 clinical trials aimed at idiopathic pulmonary fibrosis (IPF), pancreatic cancer, and liver fibrosis. Pamrevlumab has received orphan drug designation and fast track designation from the FDA for locally advanced unresectable pancreatic cancer (LAPC).
- FG-3246 (FOR46): This first-in-class antibody-drug conjugate (ADC) is in phase 1 clinical development for metastatic castration-resistant prostate cancer (mCRPC). FG-3246 targets CD46, a cell surface receptor highly expressed in prostate cancer and other tumor types.
- FG-3175: An investigational CCR8-targeted antibody designed to treat solid tumors infiltrated by CCR8-positive T regulatory cells (Tregs). The company plans to submit an IND application for FG-3175 in 2025.
Recent Achievements
In 2023, FibroGen reported encouraging financial results and significant progress in its clinical programs. The company has a robust pipeline of late-stage trials, including two for pancreatic cancer and a planned phase 2 trial for mCRPC. Financially, the company boasts a strong balance sheet with a cash runway extending into 2026, bolstered by successful corporate cost reduction initiatives. Partnerships with Astellas and AstraZeneca support the global development and commercialization of Roxadustat, while collaborations with Just-Evotec Biologics aid in manufacturing clinical trial materials.
Collaborations and Market Presence
FibroGen generates the majority of its revenue from collaboration agreements, primarily in Europe, followed by Japan. Key collaborations include Astellas and AstraZeneca, focusing on the development and commercialization of Roxadustat across various regions, including Japan, Europe, China, and others. FibroGen continues to seek partners with complementary research, development, and marketing capabilities to enhance its product development and commercialization efforts.
Investor and Media Relations
For the latest updates, financial results, conference calls, and webcasts, investors and interested parties are encouraged to visit the company’s website.
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.
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.
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