{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-26-033883","form_type":"8-K","ticker":"VTGN","cik":"0001411685","company_name":"Vistagen Therapeutics, Inc.","filed_at":"2026-05-12T11:44:41+00:00","discovered_at":"2026-05-12T11:50:00.364986+00:00","generated_at":"2026-05-12T11:50:44.807850+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Vistagen reports positive preliminary OLE data for fasedienol in SAD; well-tolerated up to 12 months","bullets":["OLE safety (n=341): discontinuation due to AEs 2.6%; no SAEs related to fasedienol; TEAEs >5%: headache 10.9%, URI 11.4%.","LSAS mean improvement: 16.3 pts at Month 1, 25.4 pts at Month 4; 56% had >=20 pt improvement at Month 4.","SPIN mean improvement: 7.9 pts at Month 1, 12.4 pts at Month 4; 55% had >=10 pt improvement at Month 4.","Baseline LSAS mean 99.2 (very severe SAD); baseline SPIN mean 48.7 (severe); improvements seen on both fear/avoidance subscales.","Non-responders in randomized portion showed comparable LSAS improvement: Month 1 =13.4, Month 4 =20.8, 50% >=20 pts."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-26-033883","json":"https://secwatch.observer/filing/0001628280-26-033883.json","markdown":"https://secwatch.observer/filing/0001628280-26-033883.md","text":"https://secwatch.observer/filing/0001628280-26-033883.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1411685/000162828026033883/0001628280-26-033883-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1411685/000162828026033883/vtgn-20260512.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-12T11:50:44.807850+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"}