Galectin reaches FDA agreement on Phase 3 endpoint for belapectin in MASH cirrhosis

GALECTIN THERAPEUTICS INC

FDA agreed on primary endpoint: composite liver outcome including prevention of large esophageal varices (>5 mm).
Company to submit Phase 3 protocol in Q3 2026; plans to evaluate single 2 mg dose of belapectin.
Galectin actively exploring strategic and financial partnerships to support development and commercialization.
FDA acknowledged substantial unmet medical need in MASH cirrhosis patients with portal hypertension.
Company expects Phase 3 trial size comparable to NAVIGATE trial (global Phase 2b/3).

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