---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-22-036896"
form_type: "8-K"
ticker: "GALT"
cik: "0001133416"
company_name: "GALECTIN THERAPEUTICS INC"
filed_at: "2022-10-12T23:59:59+00:00"
generated_at: "2026-06-23T04:00:26.467153+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA allows Galectin Therapeutics to proceed with Phase 2 trial of belapectin + Keytruda in head and neck cancer

## Summary
- FDA issued 'Study May Proceed' letter for Phase 2 trial of belapectin + pembrolizumab as first-line therapy for recurrent/metastatic PD-L1 positive head and neck squamous cell carcinoma.
- This IND is the company's second; prior investigator-initiated study provided rationale for combination.
- Company expects to complete enrollment in pivotal NAVIGATE trial in NASH cirrhosis around end of 2022.
- Company plans to engage potential partners for oncology program; financing and trial start could occur next year.

## SEC filing metadata
- accession: 0001140361-22-036896
- form_type: 8-K
- ticker: GALT
- cik: 0001133416
- company_name: GALECTIN THERAPEUTICS INC
- filed_at: 2022-10-12T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1133416/000114036122036896/0001140361-22-036896-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1133416/000114036122036896/ny20005256x3_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-22-036896
- JSON: https://secwatch.observer/filing/0001140361-22-036896.json
- Plain text: https://secwatch.observer/filing/0001140361-22-036896.txt

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