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.
Astellas Pharma and FibroGen announced that Japan's Ministry of Health has approved EVRENZO (roxadustat) for treating anemia of chronic kidney disease (CKD) in adults not on dialysis. This follows a previous approval for patients on dialysis. The approval is based on clinical studies involving over 500 patients, demonstrating non-inferiority to darbepoetin alfa. A $15 million milestone payment will be made by Astellas to FibroGen. Roxadustat is a first-in-class oral treatment that enhances hemoglobin levels by activating the body's natural response to low oxygen.
SAN FRANCISCO, Nov. 06, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced CEO Enrique Conterno will participate in fireside chats at two upcoming healthcare conferences:
- Stifel 2020 Virtual Healthcare Conference on November 17, 2020, at 1:20 PM ET
- Jefferies Virtual London Healthcare Conference on November 19, 2020, at 12:35 PM ET
Live webcasts will be available on FibroGen's Investor webpage, with replays accessible for 30 days. FibroGen focuses on developing therapeutics for unmet medical needs, including treatments for anemia and idiopathic pulmonary fibrosis.
FibroGen (NASDAQ:FGEN) reported Q3 2020 total revenue of $44.0 million, up from $33.2 million in Q3 2019, driven by strong roxadustat sales of $22.7 million in China. The company achieved a net income of $33.0 million or $0.36 per share, a significant recovery from a net loss of $49.4 million last year. FibroGen also amended its agreement with AstraZeneca to enhance profitability. Upcoming events include discussions on the U.S. NDA for roxadustat with a decision expected by December 20, 2020.
FibroGen, Inc. (NASDAQ: FGEN) will report its third quarter 2020 financial results on November 5, after market close. A conference call will be held at 5:00 p.m. ET to discuss corporate and financial performance. Investors can access the live audio webcast on the company's website. Roxadustat, a drug for anemia associated with chronic kidney disease, is highlighted, along with ongoing developments for related conditions. Pamrevlumab, another investigational therapy, is in clinical trials for multiple serious diseases.
FibroGen announced the results from two analyses of pooled data from the roxadustat global Phase 3 development program, which were presented at the ASN Kidney Week 2020. The analyses revealed that Major Adverse Cardiovascular Events (MACE) rates in chronic kidney disease (CKD) patients were highest when hemoglobin (Hb) was below 8 g/dL. Rates decreased as Hb increased and were lowest when Hb levels reached or exceeded 10 g/dL. This data supports roxadustat's efficacy and potential as a treatment for anemia in CKD patients.
FibroGen is set to present new findings on roxadustat at the ASN Kidney Week 2020, highlighting its efficacy in treating anemia in patients with chronic kidney disease (CKD). The studies will explore various patient demographics, including dialysis-dependent and non-dialysis-dependent groups, and will address the safety profile regarding cardiovascular risks and hospitalizations. The data suggests potential reductions in the need for red blood cell transfusions and emphasizes roxadustat's promise as a foundational treatment option for CKD-related anemia.
FibroGen, Inc. has appointed Percy Carter as the Chief Scientific Officer to enhance its research efforts. Dr. Carter brings over 20 years of biopharmaceutical experience, previously serving as Global Head of Discovery Sciences at Janssen. His background includes significant roles at Bristol-Myers Squibb and DuPont Pharmaceuticals, highlighting his leadership in drug discovery. CEO Enrique Conterno emphasized the importance of Dr. Carter's expertise in advancing FibroGen's unique therapeutic developments, particularly in hypoxia-inducible factor and connective tissue growth factor biology.
FibroGen, a biopharmaceutical company, announced CEO Enrique Conterno's participation in virtual healthcare conferences on September 9 and September 16, 2020. He will speak at the Citigroup 15th Annual BioPharma Conference at 2:25 PM ET and the Morgan Stanley 18th Annual Global Healthcare Conference at 3:30 PM ET. A live audio webcast can be accessed on the FibroGen Investor webpage, with replays available for 30 days. FibroGen focuses on developing innovative treatments for unmet medical needs, including roxadustat for chronic kidney disease anemia and pamrevlumab for various conditions.
FibroGen (NASDAQ: FGEN) has initiated the LELANTOS Phase 3 clinical trial to evaluate pamrevlumab in patients with non-ambulatory Duchenne muscular dystrophy (DMD). The study aims to assess muscle function improvement over 52 weeks in approximately 90 patients receiving pamrevlumab plus corticosteroids or placebo. Key endpoints include changes in upper limb performance and evaluations of pulmonary and cardiac function. This trial marks a significant milestone in FibroGen's DMD program and reflects the company's commitment to addressing this debilitating condition.
FibroGen reported Q2 2020 revenues of $42.9 million, down from $191.6 million year-over-year. This includes $15.7 million in net sales from roxadustat in China. The net loss for the quarter was $85.3 million or $0.95 per share. The company's cash position at the end of June was $716 million, with a year-end forecast of $720-$730 million. The FDA is reviewing the NDA for roxadustat, with a PDUFA date of December 20, 2020. Recent trials for pamrevlumab are ongoing, aiming to address COVID-19 and other conditions.
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