PH94B - (PALISADE-4)

Sept. 22, 2026: Vistagen (NASDAQ: VTGN) reported preliminary positive open-label extension data from the Phase 3 PALISADE-4 study of fasedienol nasal spray for acute treatment of social anxiety disorder. In the OLE safety population (N=322), 3.2 µg fasedienol used as needed up to six times daily for up to 12 months was well tolerated, with no new drug-related safety findings, no fasedienol-related serious adverse events, and a 1.6% adverse-event discontinuation rate with no discontinuations attributed to the drug. TEAEs >5% were headache (18.0%), upper respiratory tract infection (9.9%), rhinorrhoea (7.1%), and oropharyngeal pain (5.3%).

Exploratory efficacy over the first four months showed improvement on LSAS and SPIN. Mean LSAS improvement was 20.2 points at Month 1, 24.6 at Month 2, 29.1 at Month 3, and 31.4 at Month 4; 65% had at least a 20-point LSAS improvement by Month 4. Mean SPIN improvement was 10.5 points at Month 1 and 14.9 at Month 4, with 59% achieving at least a 10-point improvement by Month 4.

The company said it plans to meet with FDA during the current quarter to discuss a proposed new registrational Phase 3 trial. The randomized portion of PALISADE-4 previously missed its primary endpoint in June 2026, though a post-hoc very severe subgroup showed nominal significance (p=0.036).