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 clinical-stage biopharmaceutical company pioneering novel therapies for oncology and anemia through innovative HIF biology and antibody-drug conjugate research. This page serves as the definitive source for verified FibroGen news and official communications, providing stakeholders with timely updates on clinical developments and corporate milestones.
Investors and industry observers will find essential information including clinical trial results, regulatory submissions, and strategic partnership announcements. Our curated feed includes earnings reports, research publications, and manufacturing updates directly impacting FibroGen's progress in bringing targeted therapies to market.
Key content categories cover advancements in the company's HIF-PH inhibitor programs for anemia management, ADC oncology candidates, and updates from global collaborations. All materials are sourced from primary corporate disclosures to ensure accuracy and compliance with financial reporting standards.
Bookmark this page for streamlined access to FibroGen's latest developments. Check regularly for critical updates on pipeline progress, peer-reviewed study data, and market-moving announcements relevant to FGEN shareholders and industry analysts.
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.
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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