GALT News & Events

Galectin Therapeutics announced feedback from its recent in person Type C meeting with the FDA, supporting the advancement of belapectin for the treatment of patients with metabolic dysfunction-associated steatohepatitis, or MASH, cirrhosis and portal hypertension. Alignment was reached on a composite liver outcome as the primary endpoint, including prevention of development of large esophageal varices, a clinically meaningful manifestation of worsening portal hypertension and disease progression in patients with compensated MASH cirrhosis. The company plans to incorporate the development of large esophageal varices as one component of composite clinical outcome endpoints in the planned Phase 3 study. FDA accepted the company's proposed blinded central review process for endoscopic assessment of esophageal varices. This methodology builds upon the approach successfully implemented in the global Phase 2b/3 NAVIGATE trial and is designed to ensure standardized, objective, and consistent assessment of endoscopic outcomes across study sites. Based on the robust efficacy observed with the 2 mg dose across prior clinical studies, the company plans to evaluate a single 2 mg dose of belapectin in its planned Phase 3 trial. The company believes that the planned Phase 3 study, together with the totality of existing clinical data, has the potential to support a full approval application for belapectin in patients with MASH cirrhosis and portal hypertension. Given the similarity of the intended study population to the NAVIGATE trial, including patients with MASH cirrhosis and portal hypertension, and the evaluation of a single belapectin dose, the Company currently expects the planned Phase 3 trial to be of a size generally comparable to the NAVIGATE trial. Consistent with FDA guidance, the company understands that approval in the MASH cirrhosis population will require a traditional pathway, unlike earlier-stage MASH populations where accelerated approval based on histologic endpoints may be available. The FDA confirmed that the proposed composite outcome endpoints, including the development of large varices, and study framework are appropriate for a full approval pathway. Based on FDA's recent communication regarding use of a single, adequate and well-controlled confirmatory trial for marketing approval, the company believes the planned phase 3 trial provides a clear regulatory path toward a broad indication focused on preventing progression of MASH cirrhosis. Galectin is advancing Phase 3 planning and is actively pursuing potential strategic and financial partners. Phase 3 protocol submission is anticipated in the third quarter of 2026.

Galectin Therapeutics announced the oral and poster presentations of new analyses from its global NAVIGATE trial of belapectin at the European Association for the Study of the Liver Congress 2026, or EASL. "The analyses presented at EASL 2026 provide important new insight into how belapectin may modify disease progression in patients with advanced MASH cirrhosis and portal hypertension," said Khurram Jamil, chief medical officer of Galectin Therapeutics. "The oral presentation demonstrates a mechanistic link between modulation of fibrogenesis balance, as reflected by the Pro-C3/CTX-III ratio, and reduced varices development in high-risk patients (i.e. ELF scores greater than or equal to11.3, a threshold consistent with cirrhosis). These findings are consistent with the biologic effect we would expect to observe if belapectin is meaningfully impacting the underlying fibrotic disease process. The poster analyses further support that these biologic effects translate into clinically meaningful reductions in portal hypertension risk, including improvements in liver stiffness and Baveno risk category. Taken together, the consistency of findings across the dataset strengthens the overall evidence supporting belapectin's disease-modifying potential."

Galectin Therapeutics announced the publication of results from its NAVIGATE Phase 2b clinical trial evaluating belapectin in patients with MASH cirrhosis and portal hypertension in AASLD flagship journal Hepatology. "These results further strengthen the clinical and mechanistic profile of belapectin in MASH cirrhosis and portal hypertension," said Khurram Jamil, chief medical officer of Galectin Therapeutics. "The consistency across clinical outcomes and noninvasive biomarkers, including signals of reduced risk of clinically significant portal hypertension and variceal development, reinforces our confidence in belapectin's potential to modify disease progression. We believe these data meaningfully support continued advancement of our program, while positioning belapectin as a differentiated therapeutic candidate in MASH cirrhosis with portal hypertension-a market with significant unmet need and limited treatment options."

Galectin Therapeutics files $200M mixed securities shelf