VistaGen announced that the last patient in the randomized, double‑blind, placebo‑controlled portion of its PALISADE‑3 Phase 3 trial for fasedienol completed enrollment on November 3, 2025, marking the end of the core efficacy arm of the study.
The PALISADE‑3 trial used a public‑speaking challenge to assess acute anxiety relief and is a critical component of VistaGen’s regulatory strategy for the first‑in‑class intranasal pherine. Completion brings the company closer to submitting top‑line data and potentially filing an NDA for fasedienol as the first acute treatment for social anxiety disorder.
With the open‑label extension ongoing, VistaGen can gather additional safety and long‑term efficacy data while preparing for the anticipated top‑line results later this quarter. The milestone underscores progress in VistaGen’s pipeline and may strengthen investor confidence in the company’s ability to bring a novel therapy to market.
The announcement triggered a positive market reaction, with VistaGen’s shares rising 8.6% on November 3 and 7.61% on November 4. Analysts at Maxim Group and William Blair reiterated buy ratings, citing the trial’s completion as a key near‑term catalyst and the potential for fasedienol to become the first acute treatment for social anxiety disorder.
VistaGen’s CEO, Shawn Singh, said, “The completion of the PALISADE‑3 Phase 3 public speaking challenge study marks an important milestone for VistaGen.” He added that the data will help demonstrate fasedienol’s rapid‑onset efficacy and safety profile, supporting the company’s Fast Track designation from the FDA.
The company’s broader pipeline includes Itruvone for major depressive disorder and PH80 for menopausal hot flashes, indicating a diversified strategy beyond SAD. Financially, VistaGen reported a net loss of $14.1 million in Q3 FY2025, up from $6.4 million a year earlier, driven by increased R&D expenses of $11.3 million. The company holds $88.6 million in cash and securities as of December 31, 2024.
The PALISADE‑3 completion de‑risks the regulatory pathway and positions VistaGen to potentially file an NDA in 2026, depending on top‑line results. The first‑in‑class status and Fast Track designation could accelerate review, while the open‑label extension will provide additional safety data to support a robust submission.
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