secwatch.observer — SEC 8-K summary
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Issuer:     Vistagen Therapeutics, Inc. (VTGN)
CIK:        0001411685
Form:       8-K
Filed at:   2025-11-04T23:59:59+00:00
Accession:  0001628280-25-048827
Event type: other_material
Sentiment:  neutral
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Vistagen completes PALISADE-3 Phase 3 trial; topline results due by year end
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- Last patient completed randomized, double-blind, placebo-controlled portion of PALISADE-3 for fasedienol in social anxiety disorder; open-label extension ongoing.
- Topline results for PALISADE-3 expected in Q4 2025; PALISADE-4 topline anticipated in H1 2026.
- PALISADE-3 uses same design as positive PALISADE-2 trial (SUDS primary endpoint); FDA Fast Track designation in place.
- Successful PALISADE-3 or -4 could support NDA submission for first acute treatment for social anxiety disorder (over 30M patients).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1411685/000162828025048827/0001628280-25-048827-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1411685/000162828025048827/vtgn-20251103.htm
  HTML page:      https://secwatch.observer/filing/0001628280-25-048827

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer