{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-108179","form_type":"8-K","ticker":"MTVA","cik":"0001638287","company_name":"MetaVia Inc.","filed_at":"2025-11-07T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.018220+00:00","generated_at":"2026-05-16T23:05:07.447128+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"MetaVia Phase 2a vanoglipel shows HbA1c -0.54%p, ALT reductions in MASH trial","bullets":["At Week 16, vanoglipel monotherapy reduced HbA1c by 0.54%p and combination therapy by 0.66%p from baseline 6.99% (p<0.05 vs placebo).","Vanoglipel significantly decreased plasma ALT in patients with baseline ALT 40-200 U/L, with hepatoprotective effects driven by monotherapy.","Improvements in liver steatosis (CAP), stiffness (VCTE), and non-invasive scores (FAST, NIS-4) were observed at 16 weeks.","Circulating biomarkers of cell death (CK18F/M30), inflammation (hs-CRP, CCL2), and fibrosis (TIMP1) were reduced.","Vanoglipel 100 mg reduced pathogenic glycerolipids and glycerophospholipids; well tolerated with no discontinuations except one placebo."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-108179","json":"https://secwatch.observer/filing/0001104659-25-108179.json","markdown":"https://secwatch.observer/filing/0001104659-25-108179.md","text":"https://secwatch.observer/filing/0001104659-25-108179.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1638287/000110465925108179/0001104659-25-108179-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1638287/000110465925108179/mtva-20251107x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T23:05:07.447128+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"}