NEWS
FibroGen Announces FDA Clearance of Investigational New Drug Application for FG-3165, a Galectin-9 Targeting Monoclonal Antibody, for the Treatment of Patients with Solid Tumors
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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