Vistagen’s intranasal program fasedienol missed in a Phase 3 trial (PALISADE-4) for acute treatment of social anxiety disorder, failing to outperform placebo on the primary endpoint tied to distress during a simulated public speaking challenge. The study enrolled nearly 240 patients and reported no differences on secondary endpoints. Despite the failure, Vistagen said it will continue advancing the asset, shifting toward a longer-term treatment approach and planning to discuss a potential registrational path with the FDA. The company pointed to the FDA’s recently released draft guidance on evidence for effectiveness and cited a post-hoc analysis suggesting a nominal improvement in very severe patients. For clinical development teams, the readout reinforces how tightly Phase 3 designs can determine next steps—even where regulators may accept alternate evidence structures for subset-driven signals.