---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-026031"
form_type: "8-K"
ticker: "GALT"
cik: "0001133416"
company_name: "GALECTIN THERAPEUTICS INC"
filed_at: "2026-06-23T11:51:12+00:00"
generated_at: "2026-06-23T11:55:08.069554+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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).

## SEC filing metadata
- accession: 0001140361-26-026031
- form_type: 8-K
- ticker: GALT
- cik: 0001133416
- company_name: GALECTIN THERAPEUTICS INC
- filed_at: 2026-06-23T11:51:12+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1133416/000114036126026031/0001140361-26-026031-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1133416/000114036126026031/ef20076593_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-026031
- JSON: https://secwatch.observer/filing/0001140361-26-026031.json
- Plain text: https://secwatch.observer/filing/0001140361-26-026031.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.