---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-26-063046"
form_type: "8-K"
ticker: "VTGN"
cik: "0001411685"
company_name: "Vistagen Therapeutics, Inc."
filed_at: "2026-09-22T20:22:14+00:00"
generated_at: "2026-09-22T20:23:09.303728+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Vistagen reports positive OLE data from PALISADE-4; LSAS improved 31.4 pts at month 4

## Summary
- Safety: N=322; discontinuation due to AEs 1.6% (5/322), no fasedienol-related serious AEs; headache most common TEAE (18.0%).
- LSAS mean improvement from baseline 99.3: 20.2 pts (M1), 24.6 (M2), 29.1 (M3), 31.4 (M4); 65% achieved ≥20-pt gain by M4.
- SPIN mean improvement from baseline 48.5: 10.5 pts at M1, 14.9 pts at M4; 59% had ≥10-pt improvement.
- Company plans FDA meeting this quarter to discuss proposed new registrational Phase 3 trial of fasedienol for social anxiety disorder.
- Treatment well-tolerated up to 6x/day as-needed for 12 months; no new safety signals on labs, ECGs, or vitals.

## SEC filing metadata
- accession: 0001628280-26-063046
- form_type: 8-K
- ticker: VTGN
- cik: 0001411685
- company_name: Vistagen Therapeutics, Inc.
- filed_at: 2026-09-22T20:22:14+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1411685/000162828026063046/0001628280-26-063046-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1411685/000162828026063046/vtgn-20260922.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-26-063046
- JSON: https://secwatch.observer/filing/0001628280-26-063046.json
- Plain text: https://secwatch.observer/filing/0001628280-26-063046.txt

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