Core Viewpoint - A shareholder class action lawsuit has been filed against Vistagen Therapeutics, Inc. alleging false and misleading statements regarding the risks associated with the Phase 3 PALISADE-3 trial of fasedienol [1] Group 1: Lawsuit Details - The lawsuit claims that Vistagen failed to disclose material adverse facts related to the risks of failure in its clinical trial [1] - The class action is aimed at shareholders who purchased Vistagen shares between April 1, 2024, and December 16, 2025, and experienced significant losses [2] Group 2: Legal Representation - Holzer & Holzer, LLC is representing the shareholders in this case and has a history of recovering hundreds of millions of dollars for investors affected by corporate misconduct [3] - The deadline for shareholders to be appointed as lead plaintiff in the case is March 16, 2026 [3]

Group 1 - A class action was filed on behalf of investors who purchased or acquired Vistagen Therapeutics, Inc. common stock between April 1, 2024, and December 16, 2025 [1] - Vistagen Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for neuropsychiatric and neurological disorders [1]

NEW YORK, Jan. 15, 2026 (GLOBE NEWSWIRE) -- The following statement is being issued by Levi & Korsinsky, LLP: To: All persons or entities who purchased or otherwise acquired common stock of Vistagen Therapeutics, Inc. (“Vistagen” or the “Company”) (NASDAQ: VTGN) between April 1, 2024 and December 16, 2025, inclusive. You are hereby notified that the class action lawsuit Dan Eller v. Vistagen Therapeutics, Inc., et al. (Case No. 3:26-cv-00427) has been commenced in the United States District Court for the No ...

Core Viewpoint - Vistagen Inc. experienced a significant decline in stock price following the announcement that its PALISADE-3 Phase 3 study of intranasal fasedienol for treating social anxiety disorder did not meet its primary endpoint [1][4]. Group 1: Study Results - The PALISADE-3 study aimed to assess the efficacy and safety of a single dose of fasedienol in alleviating anxiety symptoms during a simulated public speaking challenge, measured by the Subjective Units of Distress Scale (SUDS) [2]. - The trial failed to show a statistically significant improvement in the primary endpoint, which was the change in SUDS [2]. - No treatment difference was observed between fasedienol and placebo for secondary endpoints, although the safety profile of fasedienol remained favorable and consistent with previous trials [3]. Group 2: Company Response - The CEO of Vistagen expressed disappointment over the unexpected results, noting they were inconsistent with positive outcomes from earlier studies, including Phase 2 and PALISADE-2 Phase 3 [4]. - The company is currently reviewing the study results and evaluating their potential impact on ongoing studies, with plans to seek feedback from the FDA [4]. Group 3: Financial Impact - Following the study results, Vistagen's stock price dropped by 79.53%, trading at $0.89, marking a new 52-week low [5]. - The company has implemented cash preservation measures to enhance operational efficiency and extend its cash runway into 2027 [5].

U.S. stocks traded lower midway through trading, with the Nasdaq Composite falling more than 1% on Wednesday.The Dow traded down 0.13% to 48,050.79 while the NASDAQ fell 1.18% to 22,838.26. The S&P 500 also fell, dropping, 0.73% to 6,750.66.Check This Out: Wall Street’s Most Accurate Analysts Spotlight On 3 Tech Stocks Delivering High-Dividend YieldsLeading and Lagging SectorsEnergy shares rose by 1.3% on Wednesday.In trading on Wednesday, information technology stocks fell by 1.8%.Top HeadlineGeneral Mills ...

Core Insights - Vistagen presented exploratory data at The Menopause Society 2025 Annual Meeting, highlighting the potential of PH80 as a rapidly-acting pherine product candidate for treating vasomotor symptoms such as hot flashes [1] Company Overview - Vistagen is a late clinical-stage biopharmaceutical company focused on pioneering neuroscience through nose-to-brain neurocircuitry [1] - The company is developing and commercializing a new class of intranasal product candidates known as pherines [1] Industry Context - The presentation at a prominent conference indicates the growing interest and research in treatments for menopause-related symptoms, particularly vasomotor symptoms [1]

Core Points - The article does not provide any specific insights or analysis related to a company or industry, focusing instead on the author's qualifications and disclosures [1][2][3] Group 1 - The author holds multiple degrees in engineering, computer science, business management, and computer applications from various institutions [1] - The author collaborates with another professional but emphasizes independent analysis [1] - There are no disclosed positions in any mentioned companies, indicating a lack of potential bias in the analysis [2] Group 2 - The article clarifies that past performance does not guarantee future results, which is a standard disclaimer in investment analysis [3] - It states that the views expressed may not reflect those of the platform as a whole, highlighting the independent nature of the analysis [3]

Core Viewpoint - VistaGen Therapeutics reported a quarterly loss of $0.54 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.51, indicating a negative earnings surprise of -5.88% [1][2] Financial Performance - The company posted revenues of $0.26 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 59.05%, compared to revenues of $0.18 million a year ago [2] - Over the last four quarters, VistaGen has surpassed consensus EPS estimates two times but has not beaten consensus revenue estimates [2] Stock Performance - VistaGen shares have increased approximately 38% since the beginning of the year, outperforming the S&P 500's gain of 16.5% [3] Future Outlook - The company's earnings outlook will be crucial for determining future stock movements, with current consensus EPS estimates at -$0.32 on $0.47 million in revenues for the coming quarter and -$1.56 on $0.95 million in revenues for the current fiscal year [4][7] - The estimate revisions trend for VistaGen was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which VistaGen belongs, is currently in the top 35% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% of industries [8]

Financial Data and Key Metrics Changes - As of September 30, 2025, the company reported $77.2 million in cash, cash equivalents, and marketable securities, which is expected to cover all known aspects of the ongoing U.S. registration-directed PALISADE program for fascidinol [7] Business Line Data and Key Metrics Changes - The PALISADE III Phase III trial for fascidinol, aimed at treating social anxiety disorder, has completed the randomized double-blind portion, with top-line results expected by the end of the calendar year [4][5] - The company is also preparing for the PALISADE IV Phase III trial results, which share a similar design and primary efficacy endpoint as the previously successful PALISADE II trial [6] Market Data and Key Metrics Changes - The company is focused on addressing significant unmet needs in mental health, particularly in social anxiety disorder, major depressive disorder, and menopausal hot flashes, indicating a strong market potential for its products [6] Company Strategy and Development Direction - The company aims to redefine neuroscience and improve emotional well-being through innovative treatments, with a diverse pipeline and several key milestones approaching [9] - The addition of Paul Edick to the Board of Directors is expected to enhance the company's strategic direction as it prepares for growth [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming top-line results and the potential for fascidinol to become the first FDA-approved acute treatment for social anxiety disorder [4][9] - The company is evaluating commercialization strategies, considering both independent launch and potential partnerships, to maximize the value of its innovative assets [40][41] Other Important Information - The company is committed to maintaining high-quality assessments for subject eligibility in its studies, which has led to enhancements in the PALISADE III and IV trials [16] Q&A Session Summary Question: Timeline for top-line data release - Management confirmed that top-line results are expected by the end of the calendar year [12] Question: Discontinuation rates and safety profile - Management indicated that safety data will be provided alongside top-line results, similar to PALISADE II [14] Question: Registration filing requirements - Management outlined that an NDA submission could occur around mid-2026 if the PALISADE III trial is positive, contingent on completing necessary studies and interactions with the FDA [22] Question: Eligibility for priority review voucher - Management acknowledged the unmet need in social anxiety disorder but does not currently expect fascidinol to qualify for the priority review voucher program [29] Question: Usage patterns from open-label studies - Management noted that usage patterns are expected to vary based on individual circumstances, with increased utilization during weekdays [35] Question: Commercialization strategy - Management emphasized the importance of having a solid commercial plan and the potential for strategic partnerships to enhance value [40][41]

Financial Data and Key Metrics Changes - As of September 30, 2025, the company reported $77.2 million in cash, cash equivalents, and marketable securities, which is expected to cover all known aspects of the ongoing U.S. registration-directed Palisade program for fasedienol [7][8]. Business Line Data and Key Metrics Changes - The company is preparing for the release of top-line results from the Palisade 3 study by the end of this calendar year, following the completion of the randomized double-blind portion of the trial for fasedienol [5][6]. - The Palisade 4 trial is also on track to report top-line results in the first half of 2026, with both trials sharing a similar design and primary efficacy endpoint as the previously successful Palisade 2 trial [6]. Market Data and Key Metrics Changes - The company emphasizes the significant unmet need for new treatment options for social anxiety disorder, with over 30 million patients potentially affected [28]. Company Strategy and Development Direction - The company aims to redefine treatment options in neuroscience, focusing on fasedienol as a potential first FDA-approved acute treatment for social anxiety disorder [8]. - The company is also advancing its broader pipeline, including Itruvone for major depressive disorder and PHAD for menopausal hot flashes, addressing areas with inadequate treatment options [7]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing studies and the potential for fasedienol to meet significant patient needs, highlighting the energy and commitment of the teams involved [6][8]. - The company is preparing for potential NDA submission in mid-2026 if the Palisade 3 trial is successful, indicating a proactive approach to regulatory interactions [21]. Other Important Information - The company welcomed Paul Edick to its board of directors, who brings extensive experience in FDA approvals and strategic transactions, which is expected to be valuable as the company prepares for growth [8]. Q&A Session Summary Question: Timeline for top-line data release - The company confirmed that top-line results are expected to be released before the end of the calendar quarter, aligning with previous guidance [11]. Question: Discontinuation rates and safety profile - The company will provide top-line results on primary and secondary endpoints, including safety data, similar to the previous Palisade 2 trial [12]. Question: Gating registration and filing - The company outlined that they plan to interact with the FDA as they approach the completion of the phase 3 program, with an NDA submission estimated for mid-2026 if the trial is positive [21]. Question: Eligibility for priority review voucher - The company acknowledged the unmet need for fasedienol but does not currently expect it to fall within the typical scope of the priority review voucher programs [28]. Question: Usage patterns from open-label studies - The company indicated that usage patterns will be informed by data from open-label studies, noting that utilization tends to be higher during the week when patients are in stressful environments [35]. Question: Commercialization strategy - The company is considering various options for commercialization, including potential partnerships, while emphasizing the importance of maximizing value for fasedienol [40].