secwatch.observer — SEC 8-K summary ====================================== Issuer: GALECTIN THERAPEUTICS INC (GALT) CIK: 0001133416 Form: 8-K Filed at: 2025-11-10T23:59:59+00:00 Accession: 0001140361-25-041275 Event type: other_material Sentiment: positive Materiality: 0.85 Item codes: 7.01, 9.01 LLM model: deepseek-v4-flash:cloud@v2 Galectin Therapeutics presents NAVIGATE trial: belapectin reduces varices, biomarkers improve -------------------------------------------------------------------------------- - Belapectin 2 mg/kg reduced new varices vs placebo across all ELF risk categories at 18 months; in highest risk (ELF>11.3): 22.7% vs 42.9%. - Pro-C3 biomarker showed >50% reduction from baseline at 18 months with belapectin 2 mg/kg vs placebo (mean -6.4 vs -4.5 ng/mL). - Higher proportion of belapectin 2 mg/kg patients achieved ≥20% reduction in YKL-40 (33.8% vs 23.1%); fewer had ≥20% PRO-C4 increase (3% vs 13%). - At 36 months, cumulative new varices incidence 12.4% (belapectin 2 mg/kg) vs 23.4% (placebo), sustained benefit. - Safety profile encouraging; adverse events and serious adverse events comparable to placebo, no drug-related SAEs. Source: EDGAR index: https://www.sec.gov/Archives/edgar/data/1133416/000114036125041275/0001140361-25-041275-index.htm Primary doc: https://www.sec.gov/Archives/edgar/data/1133416/000114036125041275/ny20058530x1_8k.htm HTML page: https://secwatch.observer/filing/0001140361-25-041275 License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer