{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-26-071910","form_type":"8-K","ticker":"VTGN","cik":"0001411685","company_name":"Vistagen Therapeutics, Inc.","filed_at":"2026-11-09T13:34:27+00:00","discovered_at":"2026-11-09T13:35:00.323917+00:00","generated_at":"2026-11-09T13:35:04.733382+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Vistagen says FDA Type C feedback supports LSAS endpoint path for fasedienol Phase 3 in SAD","bullets":["FDA provided constructive feedback on Vistagen's proposed use of the Liebowitz Social Anxiety Scale (LSAS) as the primary endpoint in a future Phase 3 study in adults with SAD.","Vistagen plans to add interim assessments using eDiaries and qualitative patient surveys to the Phase 3 design, then submit a revised protocol to FDA.","FDA recognized fasedienol's reported safety profile and potential to benefit a broad SAD population; Vistagen will pursue overall, not just acute, treatment of SAD.","No Phase 3 start date, enrollment target, or financing amount was disclosed; Vistagen cited the need to secure sufficient financing to advance development."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-26-071910","json":"https://secwatch.observer/filing/0001628280-26-071910.json","markdown":"https://secwatch.observer/filing/0001628280-26-071910.md","text":"https://secwatch.observer/filing/0001628280-26-071910.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1411685/000162828026071910/0001628280-26-071910-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1411685/000162828026071910/vtgn-20261109.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-11-09T13:35:04.733382+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"}