Vistagen Therapeutics, Inc. — Form 8-K

Vistagen reported preliminary data from the open-label extension (OLE) of PALISADE-4 Phase 3 trial (N=322 safety population) evaluating fasedienol nasal spray for social anxiety disorder. Safety: 1.6% discontinuation rate (5/322) due to adverse events with no discontinuations attributed to drug; >95% of adverse events mild/moderate; most common: headache (18%, 58/322), upper respiratory infection (9.9%, 32/322), rhinorrhea (7.1%, 23/322). Efficacy (4-month OLE data): LSAS score improved from baseline 99.3 to -31.4 points by month 4 (n=197, 65% achieved ≥20-point improvement); SPIN score improved -14.9 points by month 4 (n=199, 59% achieved ≥10-point improvement). Context: the randomized portion (June 2026) failed primary endpoint overall but showed nominal significance in post-hoc severe subgroup (n=123, p=0.036). Company plans FDA meeting this quarter on new registrational trial.