Vistagen reports PALISADE-4 miss on primary endpoints; positive post-hoc signal in very severe SAD subgroup

Vistagen reported PALISADE-4 did not meet its primary or secondary endpoints but showed a nominally significant post-hoc benefit in very severe social anxiety disorder patients.Key Highlights:Original SEC Filing: Vistagen Therapeutics, Inc. [ VTGN ] - 8-K - Jun. 30, 2026This is an AI-powered summar…

Vistagen reported PALISADE-4 did not meet its primary or secondary endpoints but showed a nominally significant post-hoc benefit in very severe social anxiety disorder patients.

Key Highlights:

PALISADE-4 primary endpoint: LS mean SUDS change fasedienol -9.5 vs placebo -11.4; difference 1.9 (p=0.427) — not significant.
No treatment differences observed on secondary endpoints; safety and tolerability remained favorable and consistent with prior trials.
Post-hoc in very severe SAD (LSAS ≥95, n=123): LS mean SUDS change fasedienol -12.8 vs placebo -3.7; difference -9.1 (p=0.036) — nominal significance.
Vistagen plans to meet with FDA to discuss a potential registrational path centered on an LSAS primary endpoint and a future multi-dose Phase 3 trial.
Company continues to expect cash resources to support operations into 2027 and remains focused on maximizing value of its pherine pipeline.

Original SEC Filing:

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