Galectin, FDA agree on late-stage trial design for MASH therapy

Galectin Therapeutics (GALT) announced an agreement with the FDA on the design and primary endpoint for a Phase 3 trial of belapectin for MASH-related cirrhosis. This follows the failure of its NAVIGATE Phase 2b/3 trial in 2024. Despite the regulatory progress, GALT shares fell ~9% premarket. The company expects the new study to be comparable in size to NAVIGATE, with a final protocol submission anticipated in Q3 2026.