Earnings summaries and quarterly performance for Vistagen Therapeutics.
Executive leadership at Vistagen Therapeutics.
Board of directors at Vistagen Therapeutics.
Research analysts who have asked questions during Vistagen Therapeutics earnings calls.
Andrew Tsai
Jefferies
2 questions for VTGN
Julian Pino
Jefferies
2 questions for VTGN
Madison Wynne El-Saadi
B. Riley Securities
2 questions for VTGN
Myles Minter
William Blair & Company
2 questions for VTGN
Elena Bidros
Lucid
1 question for VTGN
John Boyle
William Blair & Company
1 question for VTGN
Jo Yi Chudy
Stifel
1 question for VTGN
Linda Tsai
Jefferies
1 question for VTGN
Matthew Barcus
Jefferies
1 question for VTGN
Tim Lugo
William Blair
1 question for VTGN
Recent press releases and 8-K filings for VTGN.
- Levi & Korsinsky, LLP has filed a class action lawsuit against Vistagen Therapeutics, Inc. (NASDAQ: VTGN) for alleged securities fraud.
- The lawsuit claims Vistagen made materially misleading statements about its Phase 3 clinical trial program for its lead product candidate, an investigational pherine nasal spray for social anxiety disorder.
- Allegations include knowingly or recklessly omitting risks inherent in the clinical trial design, such as elevated placebo responses and site variability.
- The class period for shareholders who purchased securities is between April 1, 2024, and December 16, 2025.
- The company's stock price experienced a dramatic decline in December 2025 after the trial results were announced, revealing that the study did not achieve its primary endpoint.
- Vistagen Therapeutics, Inc. released a new corporate presentation on January 9, 2026, detailing its clinical-stage pipeline.
- The company is advancing Pherines, a novel class of non-systemic intranasal candidates, with five product candidates in its pipeline targeting neuropsychiatry, women's health, and cancer supportive care.
- Fasedienol, a lead candidate for the acute treatment of social anxiety disorder, is in an ongoing Phase 3 program (PALISADE); one study (PALISADE-2) met its primary endpoint, while two others (PALISADE-1 and PALISADE-3) did not.
- Itruvone demonstrated positive Phase 2a results for Major Depressive Disorder, showing rapid-onset and sustained antidepressant effects.
- Vistagen identifies large U.S. market opportunities for its lead candidates, including approximately 30 million people with social anxiety disorder and 21 million people with major depressive disorder.
- Vistagen announced that its PALISADE-3 Phase 3 study of intranasal fasedienol for the acute treatment of social anxiety disorder did not demonstrate statistically significant improvement on its primary endpoint of anxiety reduction compared to placebo.
- The study showed a least squares mean difference of 0.4 (p = not significant) on the Subjective Units of Distress Scale (SUDS) between fasedienol and placebo, with no treatment difference observed for secondary endpoints.
- Despite the lack of efficacy, favorable safety and tolerability data for fasedienol were consistent with previous clinical trials.
- In response to these unexpected results, Vistagen is reviewing the study outcomes, evaluating their impact on ongoing studies, and plans to seek feedback from the FDA.
- The company is implementing cash preservation measures to enhance operational efficiency, which are expected to provide a cash runway into 2027.
- Vistagen Therapeutics filed its fiscal year 2026 second quarter report for the period ending September 30, 2025, and announced that the last patient completed the randomized double-blind portion of its PALISADE III Phase III trial for fazodone, an intranasal product candidate for social anxiety disorder.
- Top-line results from the PALISADE III study are expected by the end of the 2025 calendar year, with PALISADE IV Phase III trial results anticipated in 2026. An NDA submission is estimated around 2026 if PALISADE III is positive.
- As of September 30, 2025, the company reported $77.2 million in cash, cash equivalents, and marketable securities, which is expected to cover the ongoing PALISADE program, including potential NDA submission.
- Paul Edick joined Vistagen's Board of Directors.
- VistaGen Therapeutics filed its quarterly report on Form 10Q for fiscal year 2026, second quarter, which ended on September 30, 2025.
- The company announced the last patient completed the randomized double-blind portion of its Palisade 3, phase 3 trial for fasedienol in social anxiety disorder, with top-line results expected by the end of the current calendar year.
- As of September 30, 2025, VistaGen had $77.2 million in cash, cash equivalents, and marketable securities, which is believed to cover the U.S. registration-directed Palisade program, including potential NDA submission.
- An NDA submission for fasedienol is estimated around mid-2026 if Palisade 3 results are positive.
- Vistagen Therapeutics completed the randomized double-blind portion of its PALISADE-3 Phase III trial for fasedienol, with topline results expected by the end of 2025.
- The company reported a cash position of $77.2 million as of September 30, 2025, which is sufficient to fund ongoing U.S. registration-directed PALISADE activities through potential NDA submission.
- For Q2 2025, Vistagen reported a widened net loss of $19.4 million and a quarterly loss of $0.54 per share, slightly worse than the consensus estimate. However, revenue was $258,000, significantly exceeding the consensus estimate.
- Paul Edick was added to the Board of Directors, enhancing leadership with his FDA approval and commercial launch experience.
- Vistagen reported a net loss of $19.4 million for the fiscal year 2026 second quarter ended September 30, 2025, with research and development (R&D) expense increasing to $15.9 million.
- As of September 30, 2025, the company held $77.2 million in cash, cash equivalents, and marketable securities.
- The PALISADE-3 Phase 3 clinical trial for fasedienol in social anxiety disorder has completed, and topline results are anticipated by calendar year end.
- Mr. Paul Edick was appointed to Vistagen's Board of Directors in October 2025.
- VistaGen Therapeutics is a late clinical-stage biopharmaceutical company focused on developing Pherines, a new class of neurocircuitry-focused drugs, with five assets in its pipeline.
- The company's lead drug candidate for acute treatment of social anxiety disorder (PH94B) offers a differentiated profile with rapid onset, non-systemic action, and no abuse liability, sexual side effects, weight gain, or sedation.
- VistaGen's PALISADE-2 Phase 3 study for social anxiety disorder successfully met its endpoints in 2023 and is considered a robust study that would count for a potential FDA filing.
- The company expects the readout of its PALISADE-3 Phase 3 study by the end of the current calendar year (2025), with a fourth study anticipated in the first half of 2026.
- VistaGen has FDA alignment on its clinical trial methodology for acute social anxiety disorder, which utilizes a public speaking challenge and the Subjective Units of Distress Scale (SUDS).
- Vistagen Therapeutics, Inc. announced the completion of the randomized, double-blind, placebo-controlled portion of its PALISADE-3 Phase 3 clinical trial for fasedienol, an acute treatment for social anxiety disorder.
- Topline results for the PALISADE-3 trial are expected by year-end.
- Topline results for the concurrent PALISADE-4 Phase 3 trial are anticipated in the first half of 2026.
- Successful results from either PALISADE-3 or PALISADE-4, combined with positive results from the PALISADE-2 trial, could provide substantial evidence to support a New Drug Application (NDA) submission to the FDA for fasedienol.
- Vistagen has completed the randomized, double-blind, placebo-controlled portion of its PALISADE-3 Phase 3 clinical trial for fasedienol, an intranasal product candidate for the acute treatment of social anxiety disorder.
- Topline results for the PALISADE-3 trial are expected by year-end.
- The company anticipates topline results for the concurrent PALISADE-4 Phase 3 trial in the first half of 2026.
- Successful results from either PALISADE-3 or PALISADE-4, combined with positive results from the earlier PALISADE-2 trial, could support a New Drug Application (NDA) submission to the FDA for fasedienol.
Quarterly earnings call transcripts for Vistagen Therapeutics.
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