secwatch.observer — SEC 8-K summary
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Issuer:     Vistagen Therapeutics, Inc. (VTGN)
CIK:        0001411685
Form:       8-K
Filed at:   2026-11-09T13:34:27+00:00
Accession:  0001628280-26-071910
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1411685/000162828026071910/0001628280-26-071910-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1411685/000162828026071910/vtgn-20261109.htm
  HTML page:      https://secwatch.observer/filing/0001628280-26-071910

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