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 clinical-stage biopharmaceutical company pioneering novel therapies for oncology and anemia through innovative HIF biology and antibody-drug conjugate research. This page serves as the definitive source for verified FibroGen news and official communications, providing stakeholders with timely updates on clinical developments and corporate milestones.
Investors and industry observers will find essential information including clinical trial results, regulatory submissions, and strategic partnership announcements. Our curated feed includes earnings reports, research publications, and manufacturing updates directly impacting FibroGen's progress in bringing targeted therapies to market.
Key content categories cover advancements in the company's HIF-PH inhibitor programs for anemia management, ADC oncology candidates, and updates from global collaborations. All materials are sourced from primary corporate disclosures to ensure accuracy and compliance with financial reporting standards.
Bookmark this page for streamlined access to FibroGen's latest developments. Check regularly for critical updates on pipeline progress, peer-reviewed study data, and market-moving announcements relevant to FGEN shareholders and industry analysts.
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.
FibroGen has entered into a comprehensive partnership with HiFiBiO Therapeutics, which includes an exclusive license for HiFiBiO's Galectin-9 program and options for CXCR5 and CCR8 programs. This transformative deal involves a $25 million upfront payment and potential milestone payments totaling up to $1.1 billion across all three programs. FibroGen will develop the Galectin-9 program worldwide, with clinical development for its lead candidate expected in Q1 2023, while the CXCR5 and CCR8 candidates are anticipated to begin clinical trials by mid-2023.
FibroGen (NASDAQ: FGEN) announced the activation of an experimental arm in the Pancreatic Cancer Action Network's Precision Promise trial. This trial aims to expedite approval of therapies for metastatic pancreatic cancer by integrating multiple stakeholders. The new arm tests FibroGen's pamrevlumab with standard chemotherapy treatments. Patients may receive pamrevlumab as a first-line treatment in the trial, aiming to enhance patient outcomes. Currently, the trial is enrolling at 15 sites nationwide, with plans for additional sites in early 2022.
FibroGen, Inc. (NASDAQ: FGEN) announced that CEO Enrique Conterno will participate in two upcoming virtual healthcare conferences: the Jefferies Virtual Healthcare Conference on June 4, 2021, at 10:30 AM ET and the Goldman Sachs 42nd Annual Global Healthcare Conference on June 10, 2021, at 3:00 PM ET. A live audio webcast will be accessible on the FibroGen Investor webpage, with a replay available for about 30 days. FibroGen focuses on developing innovative therapeutics, including roxadustat for anemia related to chronic kidney disease and pamrevlumab for various conditions.
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