Vistagen’s intranasal fasedienol failed to beat placebo in a Phase 3 program for acute social anxiety disorder, with results presented from PALISADE-4. In the trial of nearly 240 patients, fasedienol did not significantly reduce emotional distress during a simulated public speaking challenge, and the company reported no differences on secondary endpoints. The failure follows earlier disappointment in PALISADE-3, and analysts cited the repeated lack of placebo separation as a key risk to the registrational pathway. Vistagen said it will continue development and plan meetings with the FDA to align on a future evidence strategy, pointing to draft FDA guidance released last week emphasizing “various ways” to establish substantial evidence. Vistagen’s share price fell sharply after the readout, reflecting how quickly late-stage setbacks can reprice the timeline for intranasal central nervous system assets.