Vistagen provides update on timeline for ongoing trial in U.S. PALISADE program

Vistagen (VTGN) provides an update on the timeline for the ongoing clinical trials in its U.S. registration-directed PALISADE Phase 3 Program evaluating fasedienol for acute treatment of social anxiety disorder, SAD. The Company’s PALISADE-3 Phase 3 clinical trial remains on track for expected topline data in the fourth quarter of this year. Topline results for its PALISADE-4 Phase 3 clinical trial are expected in the first half of 2026. Vistagen reported positive results from its PALISADE-2 Phase 3 trial of fasedienol for acute treatment of SAD in 2023. The Company’s ongoing PALISADE-3 and PALISADE-4 Phase 3 trials involve the same public speaking challenge study design as its successful PALISADE-2 Phase 3 trial, as well as certain protocol and operational enhancements related to site training, surveillance and subject selection. These strategic enhancements, which have extended certain timelines in the PALISADE Phase 3 program, were designed with the objective of replicating the success of PALISADE-2. Vistagen believes either PALISADE-3 or PALISADE-4, if successful, together with the positive results from PALISADE-2, may establish substantial evidence of the effectiveness of fasedienol in support of a potential fasedienol New Drug Application submission to the U.S. FDA for the acute treatment of SAD.