GALT News & Events

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

Galectin Therapeutics has appointed Henry Brem, M.D., as an independent director to its Board of Directors. Dr. Brem is an internationally recognized neurosurgeon-scientist and leader in translational medicine. He serves as the Henry Brem Professor of Neurosurgery at Johns Hopkins University and previously served as Director of the Department of Neurosurgery and Neurosurgeon-in-Chief at The Johns Hopkins Medical Institutions. He is also Co-Director of the Brain Cancer Program at the Sidney Kimmel Comprehensive Cancer Center.

Galectin Therapeutics announced that the U.S. Food and Drug Administration, FDA, has provided a written response, and subsequent communications, to the Company's previously submitted Type C meeting request regarding the development program for belapectin, its investigational galectin-3 inhibitor. The FDA converted the Company's initial request for an in-person or teleconference meeting to a written response. Based on FDA's written feedback, the Company believes there is alignment with the Agency on the patient population proposed for enrollment in a registration trial. In addition, Galectin Therapeutics had previously reached an agreement with the FDA on the use of a centralized, blinded endoscopy review for esophageal variceal assessment and plans to apply a similar approach for variceal evaluation in its next study.