Vistagen (VTGN)Drops on Phase 3 Study Results for Social Anxiety Treatment

 

• Vistagen's PALISADE-3 Phase 3 trial did not meet its primary efficacy endpoint for treating social anxiety disorder.
• The company is focusing on operational efficiency to extend its financial runway into 2027.
• Vistagen's financial metrics indicate significant challenges, with negative margins and declining revenue.

Vistagen (VTGN, Financial) has reported results from its PALISADE-3 Phase 3 trial, which evaluated the efficacy of intranasal fasedienol in treating social anxiety disorder. Unfortunately, the study did not achieve the primary objective of showing a statistically significant improvement in patients' Subjective Units of Distress Scale scores. The least squares mean change from baseline did not differ significantly between fasedienol and placebo, with a mean difference of only 0.4.

Additionally, no significant differences were noted between the treatment and placebo for secondary outcomes. Despite these results, the safety profile of fasedienol remained favorable and aligned with prior trials. Vistagen's President and CEO, Shawn Singh, expressed disappointment at the unexpected outcomes of this study, which did not align with previous positive results from earlier trials. The company plans to thoroughly review the data and consult the FDA to assess the implications for ongoing research. In response to these findings, Vistagen is taking steps to preserve cash and focus on operational efficiency, aiming to extend its financial runway into 2027 while continuing to explore its pherine pipeline strategies.

https://www.gurufocus.com/news/4073618/vistagen-vtgn-phase-3-study-results-for-social-anxiety-treatment