Announcement
Galectin Therapeutics Inc (NASDAQ:GALT) reported that its shares surged approximately 20% on Tuesday following the company's disclosure of an agreement with the U.S. Food and Drug Administration (FDA) regarding the primary endpoint and regulatory pathway for the potential full approval of its investigational drug belapectin.
Trial Details
The FDA, after a recent Type C meeting, provided positive feedback and accepted a composite liver outcome as the primary endpoint for a planned Phase 3 trial. This composite outcome includes the prevention of large esophageal varices, a clinical manifestation of worsening portal hypertension in patients with compensated metabolic dysfunction‑associated steatohepatitis (MASH) cirrhosis. The agency also approved Galectin’s proposed blinded central review process for endoscopic assessment of esophageal varices, a methodology previously employed in the company’s global Phase 2b/3 NAVIGATE trial. Based on efficacy observed with a 2 mg dose in earlier studies, Galectin intends to evaluate a single 2 mg dose of belapectin in the Phase 3 study, which will be randomized, double‑blind, and placebo‑controlled. The trial size is expected to be generally comparable to the NAVIGATE trial, reflecting a similar study population.
Regulatory Pathway
The FDA clarified that approval for the MASH cirrhosis population will require the traditional full‑approval pathway rather than the accelerated approval route that is available for earlier‑stage MASH populations based on histologic endpoints. The agency confirmed that the proposed composite outcome endpoints and overall study framework are appropriate for a full‑approval pathway.
Timeline and Partnerships
Galectin plans to file the Phase 3 protocol with the FDA in the third quarter of 2026. Concurrently, the company is exploring strategic and financial partnership opportunities to support the continued development and eventual commercialization of belapectin.