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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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FibroGen, Inc. (FGEN) CEO to present at Needham Healthcare Conference, offering virtual one-on-one meetings with investors. Event details, webcast link, and replay information provided.
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FibroGen, Inc. appoints Dr. Deyaa Adib, an experienced oncology leader, as Senior Vice President & Chief Medical Officer. His extensive background in oncology drug development will drive the company's oncology pipeline forward, focusing on bringing novel cancer therapies to patients in need.
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FibroGen, Inc. (FGEN) reports positive financial results for FY 2023, with a 5% increase in total net revenue. The company anticipates topline data from pivotal pancreatic cancer trials in 2Q 2024 and additional data from a Phase 1 study in 1Q 2024. FibroGen also regains rights to roxadustat from AstraZeneca in certain territories, showing robust volume growth in China. The company's cost reduction plan has been successful, with a cash runway into 2026.
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FibroGen terminates U.S./RoW roxadustat collaboration agreement with AstraZeneca, retains rights outside China. FibroGen to explore licensing opportunities for roxadustat. Roxadustat remains a leader in China for CKD anemia treatment.
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FibroGen, Inc. (FGEN) to announce Q4 and full year 2023 financial results on February 26, 2024. Conference call scheduled to discuss corporate and financial performance.
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FibroGen, Inc. (NASDAQ: FGEN) will host a virtual KOL investor event featuring discussions on the clinical development program for pamrevlumab and FG-3246, potential first-in-class monoclonal antibodies targeting CTGF for pancreatic cancer treatment and CD46 targeting ADC for mCRPC, respectively. The event will provide information on the mechanism of action, pre-clinical and Phase 1/2 data, and ongoing trials for both treatments.
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FibroGen, Inc. (NASDAQ: FGEN) announced the completion of the pamrevlumab experimental arm in the Pancreatic Cancer Action Network's Precision PromiseSM Phase 2/3 adaptive platform trial. The topline data from this registration study is anticipated in the second quarter of 2024. Pamrevlumab achieved a protocol pre-specified ≥ 35% predictive probability of success for the primary endpoint of overall survival at the completion of the trial and graduated to the second and final stage of the trial in the third quarter of 2022. This marks a significant milestone in potential new therapy for patients with metastatic pancreatic cancer.
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FibroGen, Inc. (FGEN) presented efficacy and safety data from the MATTERHORN Phase 3 clinical study of roxadustat for the treatment of anemia in patients with lower risk transfusion-dependent myelodysplastic syndromes (MDS) at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition. The results showed a larger percentage of patients achieved transfusion independence with roxadustat vs. placebo in patients with higher transfusion burden. Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, demonstrated potential as an important new therapy for this patient population. The presentation was selected for the '2024 Highlights of ASH'.
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FibroGen, Inc. reported a 155% YoY increase in net revenue for Q3 2023, reaching $40.1 million. The company's roxadustat sNDA was accepted in China for chemotherapy-induced anemia. They achieved robust roxadustat volume growth of 37% in China. FibroGen also successfully implemented a cost reduction plan, resulting in an expected reduction of total annualized expenses of $120 million. The company expects to obtain data read-outs from two late-stage pancreatic cancer trials in 1H 2024.
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FibroGen, Inc. to announce third quarter 2023 financial results on November 6 after market close.
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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

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