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Vistagen Announces Phase 2 Results for Fasedienol Nasal Spray
Vistagen announced the topline results of its exploratory Phase 2 repeat dose study evaluating fasedienol nasal spray in adult subjects with social anxiety disorder. The three-arm, multicenter, randomized, double-blind, placebo controlled clinical study, which included an open label extension, was designed to assess the efficacy, safety, and tolerability of two 3.2 microgram doses of fasedienol administered ten minutes apart compared with a single 3.2 microgram dose and placebo, for the acute treatment of anxiety induced by a public speaking challenge. The study was not designed to demonstrate statistically significant differences between treatment groups. The exploratory study met its safety objective, demonstrating that a second dose administered within ten minutes of the first dose produced safety and tolerability data comparable to single-dose administration, with no new safety findings and overall safety findings consistent with previous clinical studies. In addition, both active treatment arms in the primary endpoint analysis, LS mean change in subjective units of distress score from Visit 2 to Visit 3, showed numerical separation from placebo, although the differences between treatment groups and placebo were not statistically significant. The primary efficacy results showed numerical separation from placebo in mean SUDS change from V2 to V3. In the prespecified analysis of patients with very severe social anxiety disorder as defined by a baseline Liebowitz Social Anxiety Scale score of greater than or equal to 95, fasedienol showed nominally statistically significant responses for the single dose arm compared with placebo and as pooled. The treatment effect for repeat dose fasedienol was numerically larger, although the smaller sample size and variability resulted in a higher p-value. The findings in the very severe group of patients defined by LSAS greater than or equal to 95 are consistent with results previously observed in the randomized portion of the company's PALISADE-4 Phase 3 trial for the acute treatment of social anxiety disorder, where in a post-hoc analysis of patients with very severe social anxiety defined by LSAS greater than or equal to 95, fasedienol also demonstrated a nominally statistically significant improvement compared with placebo. Responder rates for the Clinician Global Impression of Improvement and the Patient Global Impression of Change secondary endpoints were directionally higher for fasedienol than placebo, providing consistency across primary and secondary endpoints for the total population in the study. In addition, the fasedienol responder rates in the repeat dose arm were more than twice those observed with placebo. A prespecified exploratory analysis in V2 to V3 change of anticipatory anxiety prior to the beginning of the public speaking challenge showed a larger decrease in mean SUDS score for fasedienol compared with placebo, with the repeat dose and pooled fasedienol showing nominal statistical significance.
SRX Global Acquires Stake in Vistagen
SRX Global (SRXH) announced that it has acquired a stake in Vistagen (VTGN). The company said it views Vistagen shares as undervalued and welcomes constructive engagement with its leadership team and board of directors to discuss ideas on how to unlock shareholder value.
Vistagen PALISADE-4 Trial Results Fail to Meet Endpoint
Vistagen announced the topline results of the PALISADE-4 Phase 3 trial of intranasal fasedienol for the acute treatment of social anxiety disorder. In the overall trial population, fasedienol did not achieve its primary endpoint, as measured by the least squares mean change from baseline on the SUDS score for fasedienol compared with placebo, with a difference in the LS means of 1.9. There was no treatment difference between fasedienol and placebo for the secondary endpoints. Favorable safety and tolerability data of fasedienol were consistent with previous placebo-controlled clinical trials.
Vistagen Appoints Angel Angelov as Chief Medical Officer
Vistagen announced the appointment of Angel Angelov, MD, MBA, as Chief Medical Officer, CMO, effective May 18, 2026. Dr. Angelov most recently served as CMO at Theranica
Vistagen Reports Positive Preliminary Data from PALISADE-3 Study
Vistagen announced preliminary positive data from the ongoing open-label extension portion of its PALISADE-3 Phase 3 study of fasedienol for the acute treatment of social anxiety disorder. In a recent analysis of subjects who elected to participate in the OLE portion of PALISADE-3, administration of 3.2 microgram of fasedienol - taken as needed, up to six times per day in real-world, anxiety-provoking situations in daily life for up to 12 months - has been well-tolerated, with no new drug-related safety findings or trends identified. Exploratory efficacy data over the first four months of treatment demonstrated a clinically relevant improvement over time on both the clinician-administered Liebowitz Social Anxiety Scale and the Social Phobia Inventory. "Social anxiety disorder surfaces in the everyday moments of people's lives," said Shawn Singh, President and Chief Executive Officer of Vistagen. "Among our core goals is giving patients the ability to manage their anxiety in the daily life situations that matter most to them. We're continually encouraged by the improvements observed over time when patients in our open-label studies self-administer fasedienol as they feel it's needed."
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