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 will host the second part of its virtual Key Opinion Leader (KOL) investor event series on June 26, 2024, focusing on the FG-3246 development program for metastatic castration-resistant prostate cancer (mCRPC).
Dr. Rahul Aggarwal from the University of California, San Francisco, will discuss the unmet need and evolving treatment landscape for prostate cancer and the potential of FG-3246, a first-in-class CD46 targeting antibody-drug conjugate (ADC).
The event will also cover data from the Phase 1b/2 study evaluating FG-3246 in combination with enzalutamide, presented at the 2024 ASCO meeting. A Phase 2 monotherapy trial for FG-3246 in mCRPC is anticipated to begin in the second half of 2024. A live Q&A session will follow the presentation.
FibroGen has entered a clinical trial supply agreement with Regeneron Pharmaceuticals to test its immuno-oncology assets, FG-3165 and FG-3175, in combination with Regeneron's anti-PD-1 therapy, LIBTAYO®, for treating solid tumors.
FG-3165 targets Gal9, which suppresses T and NK cell activation. FG-3175 targets CCR8, over-expressed on T regulatory cells in tumors. Both showed complementary mechanisms with PD-1 inhibitors in preclinical studies.
FibroGen will sponsor Phase 1 trials, while Regeneron will supply the drugs. FibroGen retains rights to its compounds. The FDA has cleared the IND application for FG-3165, with an IND for FG-3175 expected in 2025.
FibroGen (NASDAQ: FGEN) announced FDA clearance for its Investigational New Drug (IND) application for FG-3165, a monoclonal antibody targeting galectin-9 (Gal9) for treating solid tumors. FG-3165 has shown anti-tumor activity and improved survival in preclinical models and exhibited excellent tolerability in nonclinical safety studies. The company plans to start enrollment for a Phase 1 clinical trial in the second half of 2024 to evaluate the safety and efficacy of FG-3165 in patients with solid tumors characterized by high Gal9 expression. CEO Thane Wettig stated that this marks a significant milestone for FibroGen's oncology pipeline.
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.
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.
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.
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.
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.
FAQ
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