Vistagen Therapeutics, Inc. 8-K

What Happened
Vistagen Therapeutics announced on December 17, 2025 (8‑K filed December 22, 2025) that its PALISADE‑3 Phase 3 study of intranasal fasedienol for the acute treatment of social anxiety disorder did not achieve the primary endpoint. The least squares (LS) mean change from baseline on the Subjective Units of Distress Scale (SUDS) was 13.6 ± 1.54 (SE) for fasedienol versus 14.0 ± 1.51 (SE) for placebo. The company reported no treatment difference on the study’s secondary endpoints. Vistagen said safety results were favorable and consistent with prior trials.

Key Details

• Study: PALISADE‑3 Phase 3 for intranasal fasedienol in social anxiety disorder.
• Primary endpoint: LS mean SUDS change — fasedienol 13.6 ±1.54 SE vs placebo 14.0 ±1.51 SE (no statistically significant benefit).
• Secondary endpoints: No treatment difference between fasedienol and placebo.
• Safety: Reported favorable and consistent with previous clinical trials. Filing signed by CEO Shawn K. Singh; 8‑K dated December 22, 2025.

Why It Matters
A Phase 3 study failing to meet its primary endpoint is material for investors because it affects the clinical and regulatory prospects of fasedienol and the value of Vistagen’s lead program. Favorable safety data may limit certain safety-related risks, but the filing does not describe next steps or changes to the development plan. Investors should watch for company updates on program strategy, regulatory guidance, or additional analyses.