Item 8.01 Other Events.
On December 17, 2025, Vistagen Therapeutics, Inc. (the "Company") announced that the PALISADE-3 Phase 3 study of intranasal fasedienol for the acute treatment of social anxiety disorder did not achieve its primary endpoint, as measured by the least squares ("LS") mean change from baseline on the the Subjective Units of Distress Scale score for fasedienol (13.6 +/-1.54 standard error, SE) compared with placebo (14.0 +/-1.51 SE). There was no treatment difference between fasedienol and placebo for the secondary endpoints. The favorable safety data of fasedienol were consistent with previously completed clinical trials.