Galectin Therapeutics Announces Positive Type C Meeting with the FDA for Belapectin in Patients with MASH Cirrhosis and Portal Hypertension
Galectin Therapeutics announced a positive Type C meeting with the FDA, reaching agreement on the primary endpoint and regulatory path for a Phase 3 trial of belapectin in MASH cirrhosis with portal hypertension. The agency agreed to a composite liver outcome focused on preventing large esophageal varices, with the Company planning to evaluate a single 2 mg dose to support a full approval application.
Key figures
- Drug Name
- Belapectin
- Phase Of Trial
- Phase 3
- Dose
- 2 mg
- Protocol submission timing
- Q3 2026
AI analysis
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