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 has announced the successful completion of patient enrollment in the MATTERHORN, a Phase 3 clinical study evaluating roxadustat for treating anemia in 141 patients with lower risk transfusion-dependent myelodysplastic syndromes (MDS). This double-blind, placebo-controlled study aims to assess transfusion independence over 28 weeks, with top-line data expected in the first half of 2023. MDS affects over 80% of diagnosed patients, highlighting the need for effective treatment options. Roxadustat, already approved in several regions for anemia in chronic kidney disease, demonstrates potential in revising MDS treatment.
FibroGen reported a 22% revenue increase in Q2 2022, totaling $29.8 million compared to $24.4 million in the same quarter last year. The company completed enrollment for the LELANTOS-2 Phase 3 trial of pamrevlumab in ambulatory DMD patients. Notably, roxadustat sales in China reached $53.1 million, marking a considerable jump in volume. However, the net loss for the quarter was $72.6 million, an improvement from a loss of $134.0 million a year ago. FibroGen expects topline data from multiple pivotal trials in 2023.
FibroGen, Inc. (NASDAQ: FGEN) will release its Q2 2022 financial results on August 8 after market close. The company will also hold a conference call at 5:00 p.m. ET to discuss its corporate and financial performance with investors. FibroGen is known for developing innovative therapeutics, including pamrevlumab for idiopathic pulmonary fibrosis, and roxadustat for various types of anemia. They have recently expanded their R&D portfolio into immuno-oncology and autoimmune therapies.
SAN FRANCISCO, July 01, 2022 (GLOBE NEWSWIRE) -- FibroGen (NASDAQ: FGEN) announces CEO Enrique Conterno will participate in a fireside chat at the William Blair Biotech Focus Conference 2022 during the week of July 11, 2022. A webcast will be available on July 11 at 9:00am ET on the FibroGen Investors webpage, with a replay accessible for 30 days. FibroGen is dedicated to developing first-in-class therapeutics, notably Pamrevlumab for various cancers and disorders, and Roxadustat, an approved treatment for anemia in multiple countries.
FibroGen (FGEN) has completed the enrollment of 73 ambulatory Duchenne muscular dystrophy (DMD) patients in its Phase 3 LELANTOS-2 clinical trial, evaluating pamrevlumab. This study aims to assess the efficacy and safety of pamrevlumab in combination with corticosteroids, focusing on ambulatory function over 52 weeks. Top-line data is expected in the second half of 2023. Pamrevlumab has received Orphan Drug and Fast Track designations from the FDA for DMD treatment. The drug is also in trials for idiopathic pulmonary fibrosis and pancreatic cancer.
FibroGen, Inc. (NASDAQ: FGEN) announced that CEO Enrique Conterno will participate in a fireside chat at the Jefferies Healthcare Conference on June 9, 2022, at 1:30 PM EDT. A live audio webcast will be available on the company's Investors webpage, with a replay accessible for up to 30 days. FibroGen focuses on developing innovative therapeutics, including pamrevlumab for conditions like idiopathic pulmonary fibrosis and roxadustat for anemia linked to chronic kidney disease. The company is also expanding into immuno-oncology and autoimmune research.
FibroGen reported a strong start in 1Q 2022 with total revenue of $60.8 million, up 58% year-over-year. The successful enrollment in the ZEHPYRUS-1 Phase 3 study for pamrevlumab in idiopathic pulmonary fibrosis and LELANTOS-1 Phase 3 study for Duchenne muscular dystrophy were highlighted. Roxadustat showed significant volume growth in China, with net sales totaling $43.5 million, despite a price reduction. The company reported a net loss of $63.2 million for the quarter, a slight improvement from the previous year, and held $565.4 million in cash as of March 31, 2022.
FibroGen (FGEN) will announce its Q1 2022 financial results on May 9 after market close, followed by a conference call at 5:00 p.m. ET. The call aims to discuss the company's corporate and financial performance in detail. FibroGen focuses on developing first-in-class therapeutics targeting unmet medical needs, with key products under development including pamrevlumab for various conditions such as idiopathic pulmonary fibrosis and roxadustat for anemia related to chronic kidney disease. A replay of the call will be available for seven days.
FibroGen, Inc. (NASDAQ: FGEN) has successfully completed the enrollment of 356 patients in the Phase 3 clinical trial ZEPHYRUS-1, aimed at evaluating pamrevlumab for treating idiopathic pulmonary fibrosis (IPF). This study is double-blind and placebo-controlled, focusing on the change in forced vital capacity (FVC) as the primary endpoint. Topline data is expected in mid-2023. Pamrevlumab is a first-in-class antibody that inhibits connective tissue growth factor (CTGF) and has received Orphan Drug and Fast Track designations from the FDA for IPF, among other indications.
FibroGen, Inc. (NASDAQ: FGEN) reported a revenue increase from $176.3 million in 2020 to $235.3 million in 2021. The company completed the enrollment for the LAPIS Phase 3 study in pancreatic cancer and the LELANTOS-1 Phase 3 study in Duchenne muscular dystrophy. FibroGen's net loss widened to $134.1 million in Q4 2021 from $58.6 million the previous year. Roxadustat achieved $186.1 million in total sales in China for 2021, up from $72.5 million in 2020. The company plans to reduce projected expenses by $100 million annually over the next three years.
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