---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-044148"
form_type: "8-K"
ticker: "GALT"
cik: "0001133416"
company_name: "GALECTIN THERAPEUTICS INC"
filed_at: "2025-12-03T23:59:59+00:00"
generated_at: "2026-05-16T15:01:31.858856+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Galectin reports NAVIGATE biomarker data consistent with clinical benefit; FDA package submitted

## Summary
- In patients with ELF >11.3 (high-risk), new varices occurred in 22.7% on belapectin vs 42.9% on placebo.
- PRO-C3, a marker of fibrogenesis, showed >50% reduction from baseline with belapectin 2 mg/kg vs placebo at 18 months.
- Belapectin reduced progression of liver stiffness on FibroScan (≥30% increase or ≥5 kPa rise) vs placebo.
- No drug-related serious adverse events; discontinuation rates similar to placebo in NAVIGATE.
- FDA package submitted; company exploring strategic partnerships and extended cash runway.

## SEC filing metadata
- accession: 0001140361-25-044148
- form_type: 8-K
- ticker: GALT
- cik: 0001133416
- company_name: GALECTIN THERAPEUTICS INC
- filed_at: 2025-12-03T23:59:59+00:00
- event_type: other_material
- 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/1133416/000114036125044148/0001140361-25-044148-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1133416/000114036125044148/ef20060348_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-044148
- JSON: https://secwatch.observer/filing/0001140361-25-044148.json
- Plain text: https://secwatch.observer/filing/0001140361-25-044148.txt

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