Regulatory2026-11-05

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

Galectin Therapeutics Inc.GALT
Indication
Non-alcoholic steatohepatitis (NASH) with cirrhosis
Stage
phase3
Event
Submission
Details

November 5, 2026: Galectin Therapeutics (NASDAQ: GALT) said it will present belapectin data at the AASLD Liver Meeting 2026 (November 5-9, Denver), including one oral presentation and two posters, one designated a Poster of Distinction, focused on MASH cirrhosis with portal hypertension.

In the NAVIGATE trial, the oral presentation on ANTICIPATE-NASH risk stratification showed belapectin was associated with a favorable shift in predicted clinically significant portal hypertension risk at 18 months, with a net 15.9% placebo-adjusted improvement (p=0.04). Variceal incidence rose with higher baseline CSPH probability but was lower with belapectin versus placebo across all risk categories.

The Poster of Distinction reported that Baveno VI/VII and ELF baseline risk categories also tracked increasing variceal risk; within each category, variceal incidence was lower with belapectin versus placebo, and ELF ≥11.3 had significantly greater new-varices incidence than lower-risk groups.

A separate GT-026 Phase 2b poster said Baveno VII and ANTICIPATE-NASH showed moderate agreement with HVPG-defined CSPH in compensated MASH cirrhosis, with Baveno VII showing slightly better concordance.

The company said these analyses will inform patient enrichment in a planned Phase 3 registration trial and noted a recent Phase 3 protocol submission to FDA.