Vistagen disclosed preliminary PALISADE-4 open-label extension data for fasedienol in social anxiety disorder, showing good tolerability over up to 12 months at 3.2 µg as-needed dosing and no new safety concerns. Efficacy signals strengthened over four months with meaningful LSAS and SPIN improvements, supporting a potential registrational pathway as FDA engagement proceeds. The randomized portion failed its primary endpoint, but a regulatory dialogue later this quarter could determine the near-term path forward.
Vistagen reported a post-hoc signal of benefit in patients with very severe social anxiety, despite PALISADE-4 missing its endpoints. The company plans to pursue a revised registrational strategy with FDA discussions, leveraging PALISADE-2 data and broader safety data to support a long-term treatment pathway. A cash runway through 2027 and a steep stock decline frame near-term risk but potential upside on regulatory progression.
VTGN's stock plunged 79.53% following trial failure. PALISADE-3 study did not meet primary efficacy endpoint. Company plans to seek FDA feedback on the trial results. Cash preservation measures were implemented for operational efficiency. VTGN shares are trading at a new 52-week low.
