Vistagen reports topline data from PALISADE-4 phase 3 trial of fasedienol

• Vistagen (NASDAQ:VTGN) announced topline results from the PALISADE-4 Phase 3 trial of intranasal fasedienol for acute treatment of social anxiety disorder.
• The trial did not meet its primary endpoint in the overall population, but showed a positive efficacy signal in a post-hoc analysis of patients with very severe social anxiety.
• Vistagen plans to discuss a potential registrational pathway with the FDA focused on overall treatment of social anxiety disorder using the LSAS as primary endpoint.

Vistagen (NASDAQ:VTGN) announced topline results from the PALISADE-4 Phase 3 trial of intranasal fasedienol for the acute treatment of social anxiety disorder.

The trial did not achieve its primary endpoint of change from baseline on the Subjective Units of Distress Scale in the overall population.

In a post-hoc analysis of patients with very severe social anxiety, fasedienol showed nominally statistically significant improvement versus placebo.

The safety profile of fasedienol was favorable and consistent with previous trials.

Based on the totality of data, Vistagen plans to transition to a potential registrational pathway focused on the overall treatment of social anxiety disorder over time, potentially supported by a single future multi-dose Phase 3 trial using the Liebowitz Social Anxiety Scale as the primary endpoint.

Vistagen is a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop intranasal pherines for anxiety, depression, and other disorders.

The company’s cash resources are expected to support operations into 2027 as it evaluates opportunities to maximize the value of its pipeline.