---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-26-071910"
form_type: "8-K"
ticker: "VTGN"
cik: "0001411685"
company_name: "Vistagen Therapeutics, Inc."
filed_at: "2026-11-09T13:34:27+00:00"
generated_at: "2026-11-09T13:35:04.733382+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Vistagen says FDA Type C feedback supports LSAS endpoint path for fasedienol Phase 3 in SAD

## Summary
- FDA provided constructive feedback on Vistagen's proposed use of the Liebowitz Social Anxiety Scale (LSAS) as the primary endpoint in a future Phase 3 study in adults with SAD.
- Vistagen plans to add interim assessments using eDiaries and qualitative patient surveys to the Phase 3 design, then submit a revised protocol to FDA.
- FDA recognized fasedienol's reported safety profile and potential to benefit a broad SAD population; Vistagen will pursue overall, not just acute, treatment of SAD.
- No Phase 3 start date, enrollment target, or financing amount was disclosed; Vistagen cited the need to secure sufficient financing to advance development.

## SEC filing metadata
- accession: 0001628280-26-071910
- form_type: 8-K
- ticker: VTGN
- cik: 0001411685
- company_name: Vistagen Therapeutics, Inc.
- filed_at: 2026-11-09T13:34:27+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1411685/000162828026071910/0001628280-26-071910-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1411685/000162828026071910/vtgn-20261109.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-26-071910
- JSON: https://secwatch.observer/filing/0001628280-26-071910.json
- Plain text: https://secwatch.observer/filing/0001628280-26-071910.txt

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