Vistagen Announces Preliminary Positive Data in Ongoing Open-Label Extension Portion of PALISADE-3 Phase 3 Study of Fasedienol for the Acute Treatment of Social Anxiety Disorder

About this update from Vistagen Therapeutics, Inc.

Fasedienol nasal spray has been well-tolerated in patients with social anxiety disorder with no new drug-related safety findings after as-needed use in daily life for up to 12 months Clinically relevant improvement in social anxiety over time was observed on both clinician-administered and patient-reported scales over four months SOUTH SAN FRANCISCO, Calif., May 12, 2026--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced preliminary positive data from the ongoing open-label extension (OLE) 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 (safety population: n=341), administration of 3.2 µg 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 (LSAS) and the Social Phobia Inventory (SPIN). "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." Preliminary Safety Data In the OLE portion of PALISADE-3, as of May 8, 2026, fasedienol nasal spray, taken as-needed, up to six times a day, was observed to be well-tolerated in adults with social anxiety disorder. Preliminary Exploratory Efficacy Data Liebowitz Social Anxiety Scale (LSAS) The OLE portion of PALISADE-3 explored the change from baseline (study entry) on the LSAS, a 24-item clinician-administered scale (range 0-144), which measures fear and avoidance experienced over time due to social anxiety disor...

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