secwatch.observer — SEC 8-K summary
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Issuer:     Vistagen Therapeutics, Inc. (VTGN)
CIK:        0001411685
Form:       8-K
Filed at:   2026-08-06T20:16:48+00:00
Accession:  0001628280-26-054341
Event type: other_material
Sentiment:  neutral
Materiality: 0.70
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Vistagen Phase 2 fasedienol study: safety met, numerical separation on primary; nominally significant in severe SAD
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- Safety objective met: repeat dose fasedienol safety comparable to single dose, no new findings.
- Primary endpoint (SUDS change) numerical separation from placebo but not statistically significant (pooled p=0.2).
- In very severe SAD (LSAS≥95), pooled fasedienol showed nominally significant improvement (p=0.04, Cohen's d=0.78).
- CGI-I and PGI-C responder rates directionally higher for fasedienol; repeat dose arm >2x placebo.
- Exploratory anticipatory anxiety endpoint: repeat dose (p=0.01) and pooled (p=0.03) nominal significance.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1411685/000162828026054341/0001628280-26-054341-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1411685/000162828026054341/vtgn-20260806.htm
  HTML page:      https://secwatch.observer/filing/0001628280-26-054341

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