Vistagen PALISADE-4 Phase 3 Trial of Fasedienol Misses Primary Endpoint; Post-Hoc Signal in Severe Subgroup

Vistagen Therapeutics, Inc.

PALISADE-4 trial (n=238) did not meet primary endpoint: LS mean change SUDS fasedienol -9.5 vs placebo -11.4 (p=0.427).
Post-hoc analysis in very severe subgroup (LSAS >=95, n=123) showed nominal significance: fasedienol -12.8 vs placebo -3.7 (p=0.036).
Fasedienol safety and tolerability consistent with previous placebo-controlled trials.
Company plans to meet with FDA to discuss registrational pathway using a single future Phase 3 trial with LSAS as primary endpoint and confirmatory evidence from PALISADE program.

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