---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-26-046143"
form_type: "8-K"
ticker: "VTGN"
cik: "0001411685"
company_name: "Vistagen Therapeutics, Inc."
filed_at: "2026-06-30T12:28:42+00:00"
generated_at: "2026-06-30T12:30:39.547191+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001628280-26-046143
- form_type: 8-K
- ticker: VTGN
- cik: 0001411685
- company_name: Vistagen Therapeutics, Inc.
- filed_at: 2026-06-30T12:28:42+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1411685/000162828026046143/0001628280-26-046143-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1411685/000162828026046143/vtgn-20260630.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-26-046143
- JSON: https://secwatch.observer/filing/0001628280-26-046143.json
- Plain text: https://secwatch.observer/filing/0001628280-26-046143.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.