{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-26-046143","form_type":"8-K","ticker":"VTGN","cik":"0001411685","company_name":"Vistagen Therapeutics, Inc.","filed_at":"2026-06-30T12:28:42+00:00","discovered_at":"2026-06-30T12:30:00.389974+00:00","generated_at":"2026-06-30T12:30:39.547191+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Vistagen PALISADE-4 Phase 3 Trial of Fasedienol Misses Primary Endpoint; Post-Hoc Signal in Severe Subgroup","bullets":["PALISADE-4 trial (n=238) did not meet primary endpoint: LS mean change SUDS fasedienol -9.5 vs placebo -11.4 (p=0.427).","Post-hoc analysis in very severe subgroup (LSAS >=95, n=123) showed nominal significance: fasedienol -12.8 vs placebo -3.7 (p=0.036).","Fasedienol safety and tolerability consistent with previous placebo-controlled trials.","Company plans to meet with FDA to discuss registrational pathway using a single future Phase 3 trial with LSAS as primary endpoint and confirmatory evidence from PALISADE program."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-26-046143","json":"https://secwatch.observer/filing/0001628280-26-046143.json","markdown":"https://secwatch.observer/filing/0001628280-26-046143.md","text":"https://secwatch.observer/filing/0001628280-26-046143.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1411685/000162828026046143/0001628280-26-046143-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1411685/000162828026046143/vtgn-20260630.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-30T12:30:39.547191+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"}