Galectin says FDA aligned on Phase 3 design for belapectin in MASH cirrhosis

Galectin Therapeutics reported financial results for the quarter ended June 30, 2026 and gave a business update on August 14, 2026. CEO Joel Lewis said the company reached an agreement with the FDA on the key elements of its planned Phase 3 trial of belapectin in MASH cirrhosis and portal hypertension and aligned on the regulatory path forward¹, and said the company is working to submit the registrational Phase 3 protocol in the third quarter¹.

The company said alignment with the FDA covered the primary endpoint of composite liver outcome, a blinded central review process for endoscopic assessment of esophageal varices, and use of a single, 2 mg/kg LBM dose of belapectin¹.

Galectin also highlighted new NAVIGATE trial data presented at the EASL Congress 2026, including an oral presentation on fibrosis modulation markers and a poster on portal hypertension risk reduction that EASL designated a TOP Poster in its Portal Hypertension session¹. The company said it published NAVIGATE Phase 2b trial results in the journal Hepatology¹ and published a separate manuscript in Gastro Hep Advances describing its centralized blinded endoscopy review system, which will also be used in the planned Phase 3 study¹.

On financing, Galectin said its chairman Richard E. Uihlein converted all outstanding principal and accrued interest under five of the company's line of credit facilities into common stock, effective July 31, 2026¹, eliminating approximately $105.8 million in total debt, consisting of $91.0 million in principal and $14.8 million in accrued interest¹, in exchange for 34,376,167 shares of common stock¹.

As of June 30, 2026, Galectin held $13.2 million of cash and cash equivalents, plus $10 million remaining available under a line of credit from its Chairman¹. The company said it believes it has sufficient cash to fund currently planned operations and research and development activities through June 2027¹.