---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-26-033883"
form_type: "8-K"
ticker: "VTGN"
cik: "0001411685"
company_name: "Vistagen Therapeutics, Inc."
filed_at: "2026-05-12T11:44:41+00:00"
generated_at: "2026-05-12T11:50:44.807850+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Vistagen reports positive preliminary OLE data for fasedienol in SAD; well-tolerated up to 12 months

## Summary
- OLE safety (n=341): discontinuation due to AEs 2.6%; no SAEs related to fasedienol; TEAEs >5%: headache 10.9%, URI 11.4%.
- LSAS mean improvement: 16.3 pts at Month 1, 25.4 pts at Month 4; 56% had >=20 pt improvement at Month 4.
- SPIN mean improvement: 7.9 pts at Month 1, 12.4 pts at Month 4; 55% had >=10 pt improvement at Month 4.
- Baseline LSAS mean 99.2 (very severe SAD); baseline SPIN mean 48.7 (severe); improvements seen on both fear/avoidance subscales.
- Non-responders in randomized portion showed comparable LSAS improvement: Month 1 =13.4, Month 4 =20.8, 50% >=20 pts.

## SEC filing metadata
- accession: 0001628280-26-033883
- form_type: 8-K
- ticker: VTGN
- cik: 0001411685
- company_name: Vistagen Therapeutics, Inc.
- filed_at: 2026-05-12T11:44:41+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1411685/000162828026033883/0001628280-26-033883-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1411685/000162828026033883/vtgn-20260512.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-26-033883
- JSON: https://secwatch.observer/filing/0001628280-26-033883.json
- Plain text: https://secwatch.observer/filing/0001628280-26-033883.txt

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