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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.

Rhea-AI Summary

FibroGen (NASDAQ: FGEN) announced that CEO Thane Wettig will participate in a Fireside Chat at the Goldman Sachs 45th Annual Global Healthcare Conference in Miami, Florida, on June 10, 2024, from 10:00-10:35 AM ET.

The company will also have one-on-one meetings with investors during the event. A live audio webcast will be accessible through the FibroGen Investor webpage, with a replay available for 90 days.

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FibroGen announced positive interim data from a Phase 1b study of FG-3246 (FOR46) in combination with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) patients. Presented at the 2024 ASCO Annual Meeting, the study revealed a median radiographic progression-free survival (rPFS) of 10.2 months in biomarker-unselected patients. FG-3246, an anti-CD46 antibody-drug conjugate, showed an acceptable safety profile with adverse events similar to other MMAE-based therapies. The recommended Phase 2 dose for FG-3246 is set at 2.1 mg/kg every three weeks alongside enzalutamide at 160 mg daily.

The trial involved 17 patients, most of whom had received at least two prior androgen receptor signaling inhibitors. The study explored dose escalation with and without granulocyte colony-stimulating factor (G-CSF) support. The primary endpoint was to determine the maximally tolerated dose (MTD) of FG-3246, established at 2.1 mg/kg ABW with primary G-CSF prophylaxis in combination with enzalutamide.

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FibroGen, Inc. (NASDAQ: FGEN) will participate in upcoming investor conferences such as Bank of America Health Care Conference and H.C. Wainwright Bioconnect Investor Conference. The company's management will engage in 1x1 investor meetings and a Fireside Chat on specific dates in May 2024.

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FibroGen, Inc. (NASDAQ: FGEN) reported strong financial results for Q1 2024, showing a 55% year-over-year net revenue growth driven by roxadustat sales in China and one-time revenue from the termination of the US/RoW AstraZeneca agreement. The company has a healthy cash balance of $214.7 million, ensuring financial stability till 2026.

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FibroGen, Inc. (NASDAQ: FGEN) will report its first quarter 2024 financial results on May 6 after the market close. The company will hold a conference call to discuss its financial and corporate performance.

Interested parties can access the live webcast on the company's website. Dial-in details are available for phone participants. A webcast replay will be available for a time.

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FibroGen, Inc. announces the selection of clinical data from the dose escalation portion of the Phase 1b/2 study of FG-3246 in combination with enzalutamide for a poster presentation at the 2024 American Society of Clinical Oncology Annual Meeting. The presentation focuses on a novel antibody-drug conjugate targeting a tumor-specific epitope of CD46 in patients with metastatic castration resistant prostate cancer.
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FibroGen, Inc. (NASDAQ: FGEN) announces positive topline data from the Phase 1 study of FG-3246, an anti-CD46 antibody drug conjugate, in metastatic castration-resistant prostate cancer patients. Key findings include a median radiographic progression free survival of 8.7 months, PSA50 response in 36% of patients, and a radiographic objective response rate of 20%. The company plans to initiate Phase 2 trials in the second half of 2024.
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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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FAQ

What is the current stock price of FibroGen (FGEN)?

The current stock price of FibroGen (FGEN) is $0.48 as of December 23, 2024.

What is the market cap of FibroGen (FGEN)?

The market cap of FibroGen (FGEN) is approximately 43.3M.

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

FGEN Stock Data

43.33M
99.96M
0.85%
55.04%
4.31%
Biotechnology
Pharmaceutical Preparations
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United States of America
SAN FRANCISCO