Key Highlights

• Primary Endpoint Not Met: Fasedienol showed an LS mean SUDS change of -9.5 versus -11.4 for placebo, a statistically insignificant result with p=0.427.

• All Secondary Endpoints Also Failed: No secondary endpoints demonstrated a significant treatment difference, compounding the primary endpoint failure.

• Stock Fell 70% to $0.23: Shares collapsed 70% to $0.23 on the data readout, reflecting the severity of the trial failure for the company's near-term regulatory prospects.

Vistagen (NASDAQ: VTGN) released topline data from its PALISADE-4 Phase 3 study evaluating intranasal fasedienol for social anxiety disorder, with results showing the drug failed to meet its primary endpoint in the 238-patient population. Shares closed down 70% at $0.23 in response to the data.

The primary endpoint analysis showed an LS mean change in the Subjective Units of Distress Scale (SUDS) of -9.5 for the fasedienol arm compared to -11.4 for the placebo arm, a numerical difference that favored placebo and produced a statistically insignificant p-value of 0.427 — far from the threshold of statistical significance required to support a regulatory submission.

Secondary endpoints also failed to demonstrate a significant treatment difference, meaning no aspect of the trial's pre-specified efficacy assessment produced a result that could support a partial or supplementary regulatory narrative. The safety profile remained favorable and consistent with prior clinical observations, providing a limited bright spot in an otherwise comprehensively negative data package.

The trial failure presents a significant challenge to fasedienol's regulatory trajectory for acute social anxiety disorder. Social anxiety disorder is a large unmet medical need with few acutely acting treatment options, and fasedienol's pheromone-based mechanism had attracted investor interest as a potentially differentiated approach. However, the PALISADE-4 failure, combined with the failure of a similar prior trial, substantially undermines the clinical development path for this indication.

Vistagen (NASDAQ: VTGN) now faces the challenge of determining whether any path forward exists for the fasedienol program, either in social anxiety disorder or potentially in other indications where the pheromone-based mechanism might be evaluated, though the company will need to carefully assess the implications of the PALISADE-4 results for any future development plans.

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