secwatch.observer — SEC 8-K summary
======================================

Issuer:     Vistagen Therapeutics, Inc. (VTGN)
CIK:        0001411685
Form:       8-K
Filed at:   2026-06-30T12:28:42+00:00
Accession:  0001628280-26-046143
Event type: other_material
Sentiment:  negative
Materiality: 0.90
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Vistagen PALISADE-4 Phase 3 Trial of Fasedienol Misses Primary Endpoint; Post-Hoc Signal in Severe Subgroup
--------------------------------------------------------------------------------

- PALISADE-4 trial (n=238) did not meet primary endpoint: LS mean change SUDS fasedienol -9.5 vs placebo -11.4 (p=0.427).
- Post-hoc analysis in very severe subgroup (LSAS >=95, n=123) showed nominal significance: fasedienol -12.8 vs placebo -3.7 (p=0.036).
- Fasedienol safety and tolerability consistent with previous placebo-controlled trials.
- Company plans to meet with FDA to discuss registrational pathway using a single future Phase 3 trial with LSAS as primary endpoint and confirmatory evidence from PALISADE program.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1411685/000162828026046143/0001628280-26-046143-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1411685/000162828026046143/vtgn-20260630.htm
  HTML page:      https://secwatch.observer/filing/0001628280-26-046143

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