{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-071953","form_type":"8-K","ticker":"VYNE","cik":"0001566044","company_name":"VYNE Therapeutics Inc.","filed_at":"2025-07-30T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.375819+00:00","generated_at":"2026-05-17T23:01:47.537405+00:00","sec_items":["2.02","8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"VYNE Phase 2b Repibresib vitiligo trial misses F-VASI50, terminates extension, seeks partner","bullets":["Primary endpoint F-VASI50 at Week 24 not met: 19.5% for 3% vs 23.4% vehicle (p=0.1245).","Key secondary endpoint F-VASI75 also not met (9.8% vs 6.4%, p=0.1468).","Nominal statistical significance for 3% dose on percent CFB in F-VASI (-43.6% vs -25.6%, p=0.002) and T-VASI (-28.3% vs -16.2%, p=0.044).","High vehicle effect and dropout rate in active arms (36.6% for 3% vs 10.6% vehicle); company ends trial extension phase.","Preliminary cash $39.6M as of June 30, 2025; company seeking partner for Repibresib."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-071953","json":"https://secwatch.observer/filing/0001104659-25-071953.json","markdown":"https://secwatch.observer/filing/0001104659-25-071953.md","text":"https://secwatch.observer/filing/0001104659-25-071953.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1566044/000110465925071953/0001104659-25-071953-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1566044/000110465925071953/tm2522042d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T23:01:47.537405+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"}