Galectin (GALT) Advances Belapectin for MASH Cirrhosis Following FDA Feedback

Galectin Therapeutics (NASDAQ: GALT) announced it will advance its drug candidate, Belapectin (GR-MD-02), into a Phase 2b/3 clinical trial for MASH cirrhosis with portal hypertension. This decision follows constructive feedback from the U.S. Food and Drug Administration (FDA), which confirmed hepatic venous pressure gradient (HVPG) as an appropriate primary endpoint for accelerated approval. The upcoming NAVIGATE-MASH trial is expected to enroll approximately 200 patients. Its primary objective will be to demonstrate a reduction in HVPG, a key indicator of liver disease severity. Secondary endpoints will assess reductions in clinical events, including variceal bleeding and ascites, which are common complications of cirrhosis. Galectin plans to initiate the NAVIGATE-MASH trial in the second half of 2026. The FDA's guidance provides a clear regulatory path for Belapectin, targeting a significant unmet medical need in patients with MASH cirrhosis and elevated portal pressure.