GR-MD-02 (belapectin) - (NAVIGATE)

June 23, 2026: Galectin Therapeutics Inc. (NASDAQ: GALT) reported positive feedback from an in-person FDA Type C meeting, reaching agreement on key elements of the Phase 3 program and a regulatory path toward potential full (traditional) approval of belapectin for patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension.

For the planned randomized, double-blind, placebo-controlled Phase 3 trial, FDA alignment included: (1) a composite liver outcome as the primary endpoint that includes prevention of development of large esophageal varices (>5 mm); (2) acceptance of the company’s proposed blinded central endoscopy review process for variceal assessment, building on the methodology used in the NAVIGATE Phase 2b/3 trial; and (3) evaluating a single 2 mg dose of belapectin in the registration trial, with trial size expected to be generally comparable to NAVIGATE.

The company stated that FDA confirmed the proposed composite outcome endpoints and study framework are appropriate for a traditional full-approval pathway in MASH cirrhosis (as opposed to accelerated approval approaches in earlier-stage MASH). Galectin plans to submit the final Phase 3 protocol in Q3 2026 and is exploring strategic and financial partnerships to support development and commercialization.