{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-26-027930","form_type":"8-K","ticker":"VTGN","cik":"0001411685","company_name":"Vistagen Therapeutics, Inc.","filed_at":"2026-04-28T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.251620+00:00","generated_at":"2026-05-15T02:48:01.960191+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Vistagen gets FDA 'Study May Proceed' letter for refisolone nasal spray in menopausal hot flashes","bullets":["FDA allows Vistagen to pursue further Phase 2 clinical development of refisolone in U.S. for vasomotor symptoms due to menopause.","Exploratory Phase 2a study (N=36): refisolone reduced hot flash frequency by 80% vs 36% placebo; effect seen by week 1 (p<.001).","Refisolone was well-tolerated with no serious drug-related adverse events in the Phase 2a study conducted in Mexico.","Company cites large unmet need: ~75% of women in America experience hot flashes during menopausal transition."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-26-027930","json":"https://secwatch.observer/filing/0001628280-26-027930.json","markdown":"https://secwatch.observer/filing/0001628280-26-027930.md","text":"https://secwatch.observer/filing/0001628280-26-027930.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1411685/000162828026027930/0001628280-26-027930-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1411685/000162828026027930/vtgn-20260422.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T02:48:01.960191+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"}