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, now Kyntra Bio, reports biopharmaceutical developments centered on oncology, rare disease and anemia assets. Recurring updates cover FG-3246, a CD46-targeting antibody-drug conjugate in development for metastatic castration-resistant prostate cancer, and FG-3180, an associated CD46-targeted PET imaging agent. News also covers roxadustat, including its approvals for anemia in chronic kidney disease in multiple non-U.S. markets and its U.S. orphan drug designation for myelodysplastic syndromes.
Company updates also include financial results, conference presentations, regulatory communications, shareholder and governance matters, and corporate-status changes. Completed corporate actions include the sale of FibroGen China operations and the 2026 name and ticker transition from FibroGen and FGEN to Kyntra Bio and KYNB.
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.
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