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 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.
FibroGen reported Q1 2021 total revenue of $38.4 million, up from $24.4 million year-over-year. This includes $15.4 million in net product revenue from roxadustat in China, part of $43.5 million total roxadustat sales, a significant increase from $29.2 million last quarter. The company faces a net loss of $71.8 million, improving from $78.3 million last year. Upcoming FDA advisory meeting for roxadustat is scheduled for July 15, 2021, with a European approval decision expected mid-2021.
FibroGen, Inc. (NASDAQ: FGEN) will announce its Q1 2021 financial results on May 10, after market close. A conference call will follow at 5:00 p.m. ET to discuss the company's performance with investors. Interested parties can access the audio webcast via FibroGen's website and are encouraged to join 15 minutes early. The company is focused on innovative therapies, including the development of roxadustat for anemia related to chronic kidney disease and other conditions, as well as pamrevlumab for various serious diseases.
FibroGen, Inc. (NASDAQ: FGEN) announced CEO Enrique Conterno will participate in a fireside chat at the BofA Securities 2021 Virtual Health Care Conference on May 13, 2021, at 5:00 PM Eastern Time. A live audio webcast will be available on the company’s investor webpage.
FibroGen is a biopharmaceutical company focused on developing innovative therapeutics, including roxadustat for anemia related to chronic kidney disease and other conditions, and pamrevlumab for various cancers and diseases.
FibroGen has received Rare Pediatric Disease Designation from the FDA for its anti-CTGF antibody, pamrevlumab, aimed at treating Duchenne muscular dystrophy (DMD). The drug has also been granted Fast Track designation and is undergoing evaluation in two Phase 3 clinical trials. The FDA's designation highlights the unmet medical needs of pediatric patients with DMD, which affects roughly 1 in 5,000 newborn boys. If approved, pamrevlumab could qualify FibroGen for a Priority Review Voucher, enhancing its future drug approval processes.
FibroGen has received FDA Fast Track designation for its anti-CTGF antibody, pamrevlumab, aimed at treating Duchenne muscular dystrophy (DMD). This designation, based on Phase 2 clinical data from non-ambulatory patients, acknowledges the unmet medical need for DMD therapies. Pamrevlumab is also in Phase 3 trials for DMD and other conditions. Approximately 20,000 children worldwide are diagnosed with DMD annually, highlighting the potential impact of this treatment.
FibroGen (NASDAQ: FGEN) announced that the FDA has scheduled a Cardiovascular and Renal Drug Advisory Committee meeting on July 15, 2021, to review the New Drug Application for roxadustat, aimed at treating anemia of chronic kidney disease (CKD) in all patients. This NDA submission is supported by positive Phase 3 results from over 8,000 patients. Roxadustat is already approved in China and Japan. It works by promoting red blood cell production and is also in development for anemia related to myelodysplastic syndromes and chemotherapy.
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