Vistagen's Social Anxiety Disorder Drug Disappoints In Pivotal Late-Stage Study

Core Viewpoint - Vistagen Inc. experienced a significant decline in stock price following the announcement that its PALISADE-3 Phase 3 study of intranasal fasedienol for treating social anxiety disorder did not meet its primary endpoint [1][4]. Group 1: Study Results - The PALISADE-3 study aimed to assess the efficacy and safety of a single dose of fasedienol in alleviating anxiety symptoms during a simulated public speaking challenge, measured by the Subjective Units of Distress Scale (SUDS) [2]. - The trial failed to show a statistically significant improvement in the primary endpoint, which was the change in SUDS [2]. - No treatment difference was observed between fasedienol and placebo for secondary endpoints, although the safety profile of fasedienol remained favorable and consistent with previous trials [3]. Group 2: Company Response - The CEO of Vistagen expressed disappointment over the unexpected results, noting they were inconsistent with positive outcomes from earlier studies, including Phase 2 and PALISADE-2 Phase 3 [4]. - The company is currently reviewing the study results and evaluating their potential impact on ongoing studies, with plans to seek feedback from the FDA [4]. Group 3: Financial Impact - Following the study results, Vistagen's stock price dropped by 79.53%, trading at $0.89, marking a new 52-week low [5]. - The company has implemented cash preservation measures to enhance operational efficiency and extend its cash runway into 2027 [5].