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, Inc. (NASDAQ: FGEN) will announce its fourth quarter and full year 2021 financial results on February 28, 2022, after market close. A conference call with investors is scheduled for the same day at 5:00 p.m. ET. This call will provide insights into the company’s corporate and financial performance.
Investors can access the call via the FibroGen website, with a replay available for 7 days post-call. FibroGen focuses on developing therapeutics for unmet medical needs, including treatments for anemia in chronic kidney disease and other conditions.
FibroGen, Inc. (NASDAQ: FGEN) announced that CEO Enrique Conterno will participate in a fireside chat at the SVB Leerink 11th Annual Global Healthcare Conference on February 18, 2022, at 3:40pm EST. The event's audio webcast will be accessible on the FibroGen Investor webpage, with a replay available for 30 days.
FibroGen focuses on developing innovative therapeutics, including roxadustat for various anemias and pamrevlumab for conditions like idiopathic pulmonary fibrosis and pancreatic cancer. The company has expanded into immuno-oncology and autoimmune research.
SAN FRANCISCO, Jan. 04, 2022 (GLOBE NEWSWIRE) -- FibroGen (NASDAQ: FGEN) announced that CEO Enrique Conterno will participate in a fireside chat at the H.C. Wainwright Bioconnect Virtual Conference from January 10-13. The session will be available on-demand starting January 10 at 7:00am EST.
Listeners can access the audio webcast via the 'Events & Presentations' section on FibroGen's Investor webpage, with a replay available for 30 days. FibroGen is focused on first-in-class therapeutics, including the development of roxadustat and pamrevlumab for various medical conditions.
FibroGen (FGEN) has extended its partnership with HiFiBiO Therapeutics by exercising an exclusive license for the anti-CCR8 monoclonal antibody program, HFB1011. This agreement involves a $35 million upfront payment plus potential milestones and royalty payments based on net sales. FibroGen gains exclusive global rights to develop products from this program, which targets CCR8, a receptor implicated in tumor immune suppression. The HFB1011 development candidate is expected to enter clinical trials in 2023, reinforcing FibroGen's focus on expanding its immuno-oncology pipeline.
FibroGen reported significant growth in Q3 2021, with total revenue reaching $156 million, a substantial increase from $44 million in Q3 2020. This surge includes a $120 million milestone payment from Astellas following EU approval of roxadustat for CKD-related anemia. The net income also rose to $49.8 million or $0.54 per share. Additionally, net product revenue from roxadustat sales in China totaled $13.4 million for the quarter, contributing to overall sales of $57.8 million.
FibroGen, Inc. (NASDAQ: FGEN) announced that CEO Enrique Conterno will participate in two upcoming healthcare conferences. The first is the Stifel 2021 Virtual Healthcare Conference on November 16, 2021, at 4:40 PM EST, followed by the Jefferies London Healthcare Conference on November 18, 2021, at 3:00 AM EST. An audio webcast will be available on the company's Investor webpage, with replays accessible for 30 days. FibroGen focuses on developing first-in-class therapeutics, including roxadustat for anemia and pamrevlumab for various disorders.
FibroGen, Inc. (NASDAQ: FGEN) will release its Q3 2021 financial results on November 9, 2021, after market close. A conference call for investors will follow at 5:00 p.m. ET to discuss the company's financial performance.
Participants can access the live audio webcast on FibroGen's website. Dial-in numbers for the call are available for both U.S./Canada and international callers. A replay of the call will be accessible shortly after the event for seven days.
FibroGen (NASDAQ: FGEN) has announced that 18 presentations from its global Phase 3 roxadustat clinical program will be featured at the American Society of Nephrology Kidney Week 2021, held virtually from November 4-7, 2021. Key highlights include 11 presentations focusing on roxadustat's efficacy in treating anemia related to chronic kidney disease (CKD) and 7 on CKD anemia epidemiology, underscoring its medical need. Roxadustat, an oral medication, is currently approved in several regions for CKD-related anemia and is in further regulatory reviews.
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.
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