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FibroGen, Inc. - FGEN STOCK NEWS

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.

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FAQ

What products is FibroGen currently developing?

FibroGen is developing Roxadustat for anemia in CKD and chemotherapy-induced anemia, Pamrevlumab for various fibrotic diseases and cancers, FG-3246 for metastatic prostate cancer, and FG-3175 for solid tumors.

Where does FibroGen generate most of its revenue?

FibroGen generates most of its revenue in Europe, followed by Japan, mainly through collaboration agreements.

What is Roxadustat?

Roxadustat is an oral HIF prolyl hydroxylase inhibitor in phase 3 development for anemia in chronic kidney disease. It is approved in several regions for CKD-related anemia.

What is Pamrevlumab?

Pamrevlumab is a monoclonal antibody in phase 2 and 3 clinical trials for idiopathic pulmonary fibrosis, pancreatic cancer, and liver fibrosis.

Who are FibroGen's key partners?

Key partners include Astellas and AstraZeneca for the development and commercialization of Roxadustat and Just-Evotec Biologics for manufacturing clinical trial materials.

What recent developments has FibroGen announced?

FibroGen announced progress in late-stage cancer trials, a strong financial outlook, and continued strength in its China business, among other updates.

What is FG-3246?

FG-3246 is a first-in-class antibody-drug conjugate targeting CD46, currently in phase 1 trials for metastatic castration-resistant prostate cancer.

What is FG-3175?

FG-3175 is an investigational CCR8-targeted antibody intended for solid tumors with high CCR8-positive T regulatory cells. An IND application is planned for 2025.

How can I access FibroGen's latest financial reports?

FibroGen's latest financial reports can be accessed via the Investor Relations section on their website.

What are the company's upcoming milestones?

Upcoming milestones include data read-outs from late-stage pancreatic cancer trials, initiation of a phase 2 trial in prostate cancer, and potentially receiving approval for Roxadustat in China.

FibroGen, Inc.

Nasdaq:FGEN

FGEN Rankings

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116.39M
99.48M
0.87%
61.98%
8.13%
Pharmaceutical Preparation Manufacturing
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