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 (NASDAQ: FGEN) has appointed David DeLucia as its new Chief Financial Officer, effective December 16, 2024, succeeding Juan Graham. DeLucia, who previously served as FibroGen's Vice President of Corporate Financial Planning and Analysis, Investor Relations, and Treasury, will lead the company's global finance organization.
DeLucia brings nearly 15 years of financial leadership experience in life sciences, including previous roles at TherapeuticsMD and JP Morgan Asset Management. The appointment comes as FibroGen advances its development of FG-3246, a first-in-class ADC targeting CD46, and its companion diagnostic FG-3180, while building on roxadustat's performance.
FibroGen (NASDAQ: FGEN) reported its Q3 2024 financial results, highlighting a 15% year-over-year net revenue growth, driven by strong performance of roxadustat in China, with a 34% volume growth. The company reiterated its full-year net product revenue guidance of $135-$150 million. Third quarter total roxadustat net sales in China reached $96.6 million, a 25% increase year-over-year. FibroGen reported a net loss of $17.1 million for Q3 2024, compared to $63.6 million in Q3 2023. The company has $160.0 million in cash, cash equivalents, and accounts receivable, sufficient to fund operations into 2026.
Upcoming milestones include topline results from the Phase 2 study of FG-3246 in mCRPC expected in 1H 2025 and the initiation of a Phase 2 monotherapy study in 1Q 2025. Additionally, FibroGen expects an approval decision for roxadustat in chemotherapy-induced anemia in China by early 2025, potentially triggering a $10 million milestone payment from AstraZeneca.
FibroGen (NASDAQ: FGEN) has scheduled its third quarter 2024 financial results announcement for Tuesday, November 12, after market close. The company will host a conference call at 5:00 PM Eastern Time to discuss corporate and financial performance with the investment community. The call will be accessible via toll-free number 1-877-300-8521 for domestic callers and 1-412-317-6026 for international investors. A webcast replay will be available on FibroGen's website investor section.
FibroGen (NASDAQ: FGEN) announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024, in New York. CEO Thane Wettig will present on Tuesday, September 10 at 3:00 PM ET at the Lotte New York Palace Hotel. The presentation will be livestreamed and later available for replay on FibroGen's website for 90 days.
The company's management team will be available for one-on-one meetings during the conference. Interested investors should contact their H.C. Wainwright representative to schedule meetings. This event provides an opportunity for FibroGen to showcase its developments and engage with potential investors.
FibroGen reported Q2 2024 financial results and provided a business update. Key points include:
- Implementing a significant cost reduction plan in the U.S., reducing workforce by ~75%
- Focusing R&D on FG-3246 and PET46 for metastatic castration-resistant prostate cancer (mCRPC)
- Q2 net revenue growth of 14% year-over-year, driven by strong roxadustat performance in China
- Raising full-year net product revenue guidance to $135-$150 million
- Cash runway projected into 2026
- Disappointing results from pamrevlumab pancreatic cancer trials
- Positive interim results for FG-3246 in mCRPC presented at ASCO 2024
- Topline results from Phase 2 FG-3246 study expected in 1H 2025
FibroGen Inc (NASDAQ: FGEN) has announced it will release its second quarter 2024 financial results on Tuesday, August 6, after the market closes. The company will host a conference call at 5:00 PM Eastern Time on the same day to discuss its corporate and financial performance with the investment community.
Investors can access the call via the following methods:
- Toll-free: 1-877-300-8521
- International: 1-412-317-6026
- Webcast: Available on FibroGen's website
FibroGen (NASDAQ: FGEN) announced disappointing results from two late-stage trials evaluating pamrevlumab in pancreatic cancer patients. The pamrevlumab arm in PanCAN's Precision Promise study for metastatic pancreatic cancer and the Phase 3 LAPIS trial for locally advanced, unresectable pancreatic cancer both failed to meet the primary endpoint of overall survival. In response, FibroGen plans to terminate the pamrevlumab development program and implement a significant cost reduction plan, including a 75% reduction in U.S. workforce. The company will focus on its collaboration with AstraZeneca for roxadustat in China and with Astellas in other territories. Despite the setback, pamrevlumab was generally safe and well-tolerated across both studies.
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.
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