{"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","discovered_at":"2026-06-23T11:55:00.308614+00:00","generated_at":"2026-06-23T11:55:08.069554+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Galectin reaches FDA agreement on Phase 3 endpoint for belapectin in MASH cirrhosis","bullets":["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)."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-026031","json":"https://secwatch.observer/filing/0001140361-26-026031.json","markdown":"https://secwatch.observer/filing/0001140361-26-026031.md","text":"https://secwatch.observer/filing/0001140361-26-026031.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-23T11:55:08.069554+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}