USFDAJun 23, 2026, 08:01 AM
Galectin Therapeutics gets FDA agreement for belapectin Phase 3
AI Summary
Galectin Therapeutics Inc. announced positive results from its Type C meeting with the U.S. Food and Drug Administration (FDA) regarding belapectin for MASH cirrhosis and portal hypertension. The company reached agreement with the FDA on the primary endpoint and regulatory path forward for potential full approval. Galectin plans to file the Phase 3 protocol in Q3 2026 and is actively seeking strategic and financial partners to support development and commercialization.
Key Highlights
- Galectin Therapeutics received positive feedback from the FDA for belapectin in MASH cirrhosis.
- FDA agreed on the primary endpoint and regulatory path for potential full approval of belapectin.
- Company plans to file the Phase 3 protocol in Q3 2026.
- Galectin is actively exploring strategic and financial partnership opportunities for belapectin.
- Phase 3 trial will assess belapectin's safety and efficacy for MASH cirrhosis and portal hypertension.
- Primary endpoint includes prevention of large esophageal varices, a clinically meaningful outcome.
- FDA accepted the proposed blinded central review process for endoscopic assessment.
- Planned registration trial will evaluate a single 2 mg dose of belapectin.
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