{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-26-041962","form_type":"8-K","ticker":"VTGN","cik":"0001411685","company_name":"Vistagen Therapeutics, Inc.","filed_at":"2026-06-09T21:04:52+00:00","discovered_at":"2026-06-09T21:06:00.369208+00:00","generated_at":"2026-06-09T21:06:40.404285+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Vistagen achieves ICH E1 safety exposure minimum for fasedienol; over 1,500 subjects dosed","bullets":["As of May 31, 2026: over 1,500 subjects with ≥1 dose, 300 with ≥6 months, 100 with ≥12 months exposure to fasedienol.","Milestone supports safety database for NDA; FDA alignment on specific exposure requirements still pending.","Topline results from PALISADE-4 Phase 3 trial expected Q2 2026; Phase 2 Repeat Dose study topline due Q3 2026.","Fasedienol is a pherine nasal spray for acute treatment of social anxiety disorder; no new safety signals reported.","CEO notes encouraging subject participation in open-label extensions and well-tolerated profile across trials."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-26-041962","json":"https://secwatch.observer/filing/0001628280-26-041962.json","markdown":"https://secwatch.observer/filing/0001628280-26-041962.md","text":"https://secwatch.observer/filing/0001628280-26-041962.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1411685/000162828026041962/0001628280-26-041962-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1411685/000162828026041962/vtgn-20260609.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-09T21:06:40.404285+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"}