other material
confidence high
sentiment neutral
materiality 0.70
Vistagen Phase 2 fasedienol study: safety met, numerical separation on primary; nominally significant in severe SAD
Vistagen Therapeutics, Inc.
- Safety objective met: repeat dose fasedienol safety comparable to single dose, no new findings.
- Primary endpoint (SUDS change) numerical separation from placebo but not statistically significant (pooled p=0.2).
- In very severe SAD (LSAS≥95), pooled fasedienol showed nominally significant improvement (p=0.04, Cohen's d=0.78).
- CGI-I and PGI-C responder rates directionally higher for fasedienol; repeat dose arm >2x placebo.
- Exploratory anticipatory anxiety endpoint: repeat dose (p=0.01) and pooled (p=0.03) nominal significance.