Galectin Therapeutics reports FDA Type C meeting agreement on belapectin Phase 3 design
Galectin Therapeutics said its Type C meeting with the FDA produced agreement on the primary endpoint and regulatory path for a potential full approval of belapectin in patients with MASH cirrhosis and portal hypertension. The company plans to file the Phase 3 protocol in the third quarter of 2026 and is exploring strategic and financial partnerships to support development.
Key points
- FDA agreed to a composite liver outcome primary endpoint that includes prevention of large esophageal varices (>5 mm)
- FDA accepted the company's proposed blinded central review process for endoscopic assessments, based on the NAVIGATE trial approach
- Company plans a single 2 mg dose in the Phase 3 trial and expects a trial size generally comparable to NAVIGATE
- Phase 3 protocol submission anticipated in the third quarter of 2026; company is actively pursuing partners
The filing
Written by AI on Nov 9, 2026, 8:36 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on June 23, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.