Vistagen Inc. (NASDAQ:VTGN) stock is plunging on Wednesday, with a session volume of 20.91 million compared to the average volume of 711,000, as per data from Benzinga Pro.
The clinical-stage biopharmaceutical company focused on neuroscience announced that the PALISADE-3 Phase 3 study of intranasal fasedienol for the acute treatment of social anxiety disorder did not achieve its primary endpoint.
PALISADE-3 public speaking challenge study was designed to evaluate the efficacy and safety of a single dose of fasedienol in reducing anxiety symptoms during a simulated public speaking challenge using the Subjective Units of Distress Scale (SUDS).
The trial did not demonstrate a statistically significant improvement in the primary endpoint, change in the Subjective Units of Distress Scale (SUDS).
There was no treatment difference between fasedienol and placebo for the secondary endpoints. The favorable safety data of fasedienol were consistent with previous clinical trials.
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“We are disappointed by the unexpected results of this public speaking challenge trial, which are inconsistent with positive outcomes observed in Phase 2 and our PALISADE-2 Phase 3 study,” said Shawn Singh, president and chief executive officer of Vistagen. “We are thoroughly reviewing the results of the study, evaluating the potential impact of the results on our ongoing studies, and plan to seek feedback from the FDA.
The company implemented cash preservation measures to enhance operational efficiency and provide a cash runway into 2027.
VTGN Price Action: Vistagen Therapeutics shares were down 79.53% at $0.89 at the time of publication on Wednesday. The stock is trading at a new 52-week low, according to Benzinga Pro data.
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