Galectin Therapeutics IncFDA alignment on primary endpoint and regulatory path for belapectin Phase 3 trial in MASH cirrhosis

Galectin Therapeutics reached alignment with the U.S. Food and Drug Administration on the primary endpoint and regulatory path for belapectin in MASH cirrhosis and portal hypertension. The pivotal Phase 3 trial will be a randomized, double-blind, placebo-controlled study evaluating a single 2mg dose of belapectin for prevention of disease progression in patients with MASH cirrhosis and portal hypertension. The FDA and the company aligned on a composite clinical endpoint expected to include prevention of disease progression and development of large esophageal varices greater than 5 mm, and the FDA accepted the company's proposed blinded central review process for endoscopic assessment of esophageal varices. Galectin intends to submit the Phase 3 protocol in the third quarter of 2026 and is actively exploring strategic and financial partnership opportunities to advance belapectin. Shares of Galectin were trading at $3.20, up 14.31%.
Galectin Therapeutics IncFDA alignment on primary endpoint and regulatory path for belapectin Phase 3 trial in MASH cirrhosis