Vistagen Therapeutics, Inc. — Form 8-K

Vistagen announced topline results from a Phase 2 exploratory repeat-dose study (N=61) of fasedienol nasal spray for acute social anxiety disorder. The study was not powered for statistical significance on the primary endpoint (SUDS score change V2–V3: pooled fasedienol -15.0 vs. placebo -6.8, p=0.10). However, a prespecified subgroup analysis in patients with very severe social anxiety (LSAS ≥95) showed nominal statistical significance for pooled fasedienol (p=0.04, Cohen's d=0.78) and single-dose arm (p=0.05). Secondary endpoints (CGI-I and PGI-C responder rates) showed directional improvements; repeat-dose responder rates were 2–4× placebo. Safety and tolerability of repeat dosing matched single-dose profile with no new safety signals. The company intends to use these results in FDA discussions regarding a registrational pathway.