Vistagen Reports Q3 2026 Results, Advances PALISADE-4 Trial and Menopause Drug Development

Vistagen reported financial results for its fiscal year 2026 third quarter ended December 31, 2025, and provided updates on its clinical programs. The company expects topline results from the randomized portion of its ongoing PALISADE-4 Phase 3 trial of fasedienol for the acute treatment of social anxiety disorder in the first half of 2026.

The company has reviewed available data from PALISADE-3 and implemented moderate refinements, including retraining, site rationalization, and operational enhancements to the ongoing PALISADE-4 Phase 3 trial. With outside collaborators and their proprietary artificial intelligence and machine learning methodologies, Vistagen is conducting an extensive analysis across all available PALISADE Program datasets to potentially inform modifications to the statistical analysis plan for PALISADE-4 and its regulatory strategy.

In December 2025, Vistagen announced topline results from the randomized portion of its PALISADE-3 Phase 3 trial of fasedienol for the acute treatment of social anxiety disorder. PALISADE-3 did not achieve its primary endpoint, as measured by the least squares (LS) mean change from baseline on the Subjective Units of Distress (SUDS) score for fasedienol compared with placebo. The fasedienol safety data in the randomized portion of PALISADE-3 were favorable and consistent with previously reported results from other fasedienol Phase 3 clinical trials. No drug-related severe or serious adverse events were reported for fasedienol in the randomized portion of PALISADE-3 or in prior fasedienol Phase 3 clinical trials.

Both PALISADE-3 and PALISADE-4 open-label portions remain ongoing for real-world safety and exploratory efficacy assessments using LSAS and SPIN scales. The company is leveraging advanced analytics, including artificial intelligence and machine learning, across all PALISADE studies to address placebo response and optimize regulatory submission strategy. Potential New Drug Application submission to the FDA would occur if PALISADE-4 is successful, together with PALISADE-2 and the broader body of evidence.

The company received an adoption statement from the United States Adopted Names Council (USAN) officially designating PH80, its hormone-free, non-systemic product candidate for treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause and potentially other women's health indications, by the generic name "refisolone." Vistagen is currently preparing an Investigational New Drug application (IND) for submission to the U.S. Food and Drug Administration (FDA), with a planned submission in the first half of 2026, to facilitate further Phase 2 clinical development of refisolone in the U.S. as a potential treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause.

In previously completed placebo-controlled Phase 2A clinical trials, refisolone demonstrated statistically significant reductions in the frequency and severity of hot flashes. The Phase 2A trials were conducted in Mexico by Pherin Pharmaceuticals, now a wholly owned subsidiary of Vistagen.

The company has implemented targeted, company-wide cash preservation initiatives and remains committed to disciplined capital allocation and preserving strategic flexibility as it approaches key clinical milestones in 2026.

For the three months ended December 31, 2025, research and development expense was $14.2 million, as compared to $11.3 million for the three months ended December 31, 2024. The increase in R&D expense was primarily due to higher research, development, and contract manufacturing expenses, as well as headcount related to the U.S. registration-directed PALISADE Program for fasedienol in social anxiety disorder.

General and administrative expense was $5.6 million for the three months ended December 31, 2025, as compared to $4.0 million for the three months ended December 31, 2024. This increase in G&A expense was primarily due to increases in consulting and professional fees.

Net loss was $18.9 million for the three months ended December 31, 2025, as compared to $14.1 million for the three months ended December 31, 2024. Cash, cash equivalents, and marketable securities were $61.8 million as of December 31, 2025.

In December, Vistagen announced the appointment of a new Chief Financial Officer.