Biopharma · FDA Approvals · Stock
Galectin Therapeutics Inc is a clinical-stage biopharmaceutical company. The company focuses on drug research and development to create new therapies for fibrotic disease, cancer, and selected other diseases. Its galectin-3 inhibitor is belapectin (GR-MD-02), which has been demonstrated in preclinical models to reverse…
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Galectin Therapeutics: FDA aligns on Phase 3 belapectin design
FDA agreed on the Phase 3 primary endpoint (composite liver outcome including large esophageal varices) and full-approval regulatory path for belapectin in MASH cirrhosis with portal hypertension. The company will submit the final Phase 3 protocol in Q3 2026 and is seeking strategic/financial partners.
GALT presents NAVIGATE trial biomarker data at AASLD 2025
The company presented new biomarker analyses from the Phase 2 NAVIGATE trial at the AASLD 2025 meeting. Belapectin 2 mg/kg showed consistent antifibrotic effects across ELF, Pro-C3, YKL-40, and PRO-C4 biomarkers, with sustained reduction in new varices through 36 months. These data reinforce the drug's disease-modifying potential in compensated MASH cirrhosis with portal hypertension.
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