VistaGen Therapeutics, Inc.

Vistagen Reports Positive Findings Supporting Fasedienol’s Potential in Very Severe Social Anxiety Disorder

Vistagen presented exploratory data at Psych Congress 2026 supporting fasedienol's potential in very severe social anxiety disorder (baseline LSAS of 95 or higher). Subpopulation analyses from PALISADE-4 Phase 3 and a Phase 2a repeat dose study showed statistically significant SUDS improvements versus placebo, with greater benefit after a second dose taken 10 minutes later; PALISADE-4 missed its primary endpoint in the total population. Safety and tolerability were consistent with prior trials, with no serious drug-related safety signals identified.

•1mo ago

Vistagen Announces Preliminary Positive Data from Open-Label Extension Portion of PALISADE-4 Phase 3 Study of Fasedienol for the Acute Treatment of Social Anxiety Disorder

Vistagen reported preliminary positive data from the open-label extension of its PALISADE-4 Phase 3 study, with fasedienol nasal spray well-tolerated over up to 12 months of as-needed use and no new drug-related safety findings; discontinuations due to adverse events were 1.6% and none were attributed to the drug. Exploratory efficacy showed clinically relevant improvement over four months: mean LSAS gains grew from 20.2 points at Month 1 to 31.4 points at Month 4 from a very severe baseline of 99.3, while the patient-reported SPIN improved 14.9 points by Month 4. Context matters: the randomized, placebo-controlled portion of PALISADE-4 missed its primary endpoint in June 2026, and the positive signal cited comes from an open-label dataset plus a post-hoc very severe subgroup analysis (p=0.036) rather than a controlled readout. Vistagen is preparing to meet with the FDA during the current quarter to consider a proposed new registrational Phase 3 trial of fasedienol in social anxiety disorder.

•1mo ago

Vistagen to Present at Psych Congress 2026

Vistagen will present data at Psych Congress in New Orleans on September 17-18 highlighting a positive efficacy signal for its Phase 3 candidate fasedienol nasal spray in public speaking challenge participants with very severe social anxiety disorder. The poster (No. 230) presents subgroup analyses of participants with baseline LSAS scores of 95 or higher, drawn from two multi-center, randomized, placebo-controlled public speaking challenge trials. Fasedienol is Vistagen's most advanced intranasal pherine candidate, alongside itruvone for major depressive disorder and refisolone for menopause-related vasomotor symptoms. The data are a modest supporting datapoint for the lead asset, not a new pivotal efficacy readout.

•1mo ago

SRX Global Acquires Stake in Vistagen Therapeutics (NASDAQ: VTGN)

SRX Global announced it has acquired a stake in Vistagen Therapeutics, a clinical-stage biopharmaceutical company focused on neurocircuitry and pherines. The company views Vistagen shares as undervalued and intends to engage with its leadership and board to discuss unlocking shareholder value. SRX Global is an AI-driven platform dedicated to generating shareholder value through investments in operating companies and strategic assets.

•2mo ago

Vistagen Appoints Douglas J. Williamson to its Board of Directors

Vistagen appointed Douglas J. Williamson, MD, to its Board of Directors, adding leadership experience in neuroscience drug development and regulatory approval. Dr. Williamson previously served as Chief Medical Officer of QurAlis and EVP of R&D at Acadia Pharmaceuticals, contributing to the approval of neuropsychiatric therapies like Symbyax and Zyprexa during his tenure at Eli Lilly. The company is currently advancing intranasal pherine product candidates, including fasedienol for social anxiety disorder in Phase 3 and itruvone for major depressive disorder in Phase 2.

•3mo ago

Vistagen Achieves Minimum ICH Safety Exposure Recommendations Across Clinical Program for Fasedienol for the Acute Treatment of Social Anxiety Disorder

Vistagen announced that its clinical program for fasedienol nasal spray has achieved the minimum patient exposures recommended under ICH E1 for long-term treatment of non-life-threatening conditions. As of May 31, 2026, over 1,500 subjects have received at least a single exposure, with over 300 subjects exposed for at least 6 months and over 100 for at least 12 months. Topline results from the pivotal PALISADE-4 Phase 3 trial are expected in Q2 2026, which could support a potential NDA submission if successful.

•4mo ago

Vistagen Receives FDA “Study May Proceed” Letter Under its Refisolone IND Application, Enabling Further Phase 2 Clinical Development for the Treatment of Vasomotor Symptoms (Hot Flashes) due to Menopause

Vistagen received a 'Study May Proceed' letter from the FDA for its Refisolone IND application, clearing the way for further Phase 2 clinical development in the U.S. for menopausal vasomotor symptoms. The regulatory decision builds on exploratory Phase 2a data where Refisolone demonstrated an 80% reduction in hot flash frequency compared to 36% for placebo, with no serious adverse events. Refisolone is a non-hormonal, non-systemic pherine nasal spray designed to target a large unmet need in women’s health, offering a potential alternative to current systemic treatments.

•6mo ago