VTGN

We recently compiled a list of the 7 Best Psychedelic Stocks to Buy According to Analysts. Vistagen Therapeutics, Inc. (NASDAQ:VTGN) is one of the best psychedelic stocks on our list. TheFly reported on June 30 that VTGN announced topline findings from the PALISADE-4 Phase 3 trial evaluating intranasal fasedienol for the acute treatment of social anxiety disorder. The study did not meet its primary endpoint, with fasedienol failing to demonstrate a statistically meaningful improvement compared with placebo based on the change from baseline in SUDS scores. The trial also showed no treatment advantage over placebo across secondary endpoints. However, fasedienol maintained a favorable safety and tolerability profile, consistent with observations from earlier placebo-controlled clinical studies. Separately, earlier on June 15, Vistagen Therapeutics, Inc. (NASDAQ:VTGN) reported its financial results for the fiscal year ended March 31, 2026, along with a corporate update. Research and development expenses increased to $55.0 million from $39.4 million in the prior fiscal year, primarily due to activities supporting the PALISADE Program for fasedienol, manufacturing efforts, and development of the company’s pherine candidates. General and administrative expenses rose to $18.4 million compared with $17.1 million a year earlier. The company recorded a net loss of $69.7 million for the fiscal year, compared with $51.4 million in the previous period. As of March 31, 2026, VTGN reported $45.4 million in cash, cash equivalents, and marketable securities, which it expects to support operations into 2027. Vistagen Therapeutics, Inc. (NASDAQ:VTGN) is a clinical-stage neuroscience company developing rapid-onset intranasal therapies for psychiatric disorders. It is often categorized among psychedelic stocks due to its focus on mental health innovation, though its proprietary therapies are not classic psychedelics. While we acknowledge the potential of VTGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and 15 Stocks That Will Make You Rich in 10 Years Disclosure: None. Fo...

Completed randomized portion of PALISADE-4 Phase 3 trial of fasedienol for the acute treatment of social anxiety disorder; topline results expected this month Completed randomized portion of fasedienol Phase 2 repeat dose study; topline results expected in third quarter 2026 Achieved minimum ICH E1 safety exposure recommendations across fasedienol clinical program Reported preliminary positive data from open-label extension portion of PALISADE-3 Phase 3 trial Received FDA "Study May Proceed" letter under refisolone Investigational New Drug (IND) application to support further clinical development in the U.S. for treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause SOUTH SAN FRANCISCO, Calif., June 15, 2026--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today reported financial results for its fiscal year ended March 31, 2026, and provided a corporate update. "We made meaningful progress in fiscal 2026, advancing three significant late-stage programs in our novel pherine pipeline for people living with social anxiety disorder, depression, and menopausal hot flashes," said Shawn Singh, President and Chief Executive Officer of Vistagen. "We expect topline results from the randomized portion of our PALISADE-4 Phase 3 trial later this month. If successful, we believe that PALISADE-4, together with the positive results from our PALISADE-2 Phase 3 trial and further evidence we plan to generate to support the clinical meaningfulness of the duration and magnitude of effect of fasedienol, could provide substantial evidence of effectiveness in support of a potential fasedienol NDA for the acute treatment of social anxiety disorder. We remain steadfast in our commitment to helping improve lives underserved by current treatment options." Corporate and Program Highlights Fasedienol for the Acute Treatment of Social Anxiety Disorder Completed the randomized portion of the PALISADE-4 Phase 3 trial evaluating fasedienol for the acute treatment of social anxiety disorder; topline results from the randomized portion of PALISADE-4 are expected in June 2026. Refined the PALISADE-4 statistical analysis plan (SAP), incorporating baseline pre-dose Subjective Units...

HealthEquity (HQY) came out with quarterly earnings of $1.24 per share, beating the Zacks Consensus Estimate of $1.11 per share. This compares to earnings of $0.97 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +11.57%. A quarter ago, it was expected that this provider of services for managing health care accounts would post earnings of $0.89 per share when it actually produced earnings of $0.95, delivering a surprise of +6.74%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. HealthEquity, which belongs to the Zacks Medical Services industry, posted revenues of $354.64 million for the quarter ended April 2026, surpassing the Zacks Consensus Estimate by 0.06%. This compares to year-ago revenues of $330.84 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. HealthEquity shares have lost about 5.5% since the beginning of the year versus the S&P 500's gain of 9.9%. While HealthEquity has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for HealthEquity was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the compl...

We recently compiled a list of the 10 Best Penny Stocks Under $1 According to Hedge Funds. Vistagen Therapeutics, Inc. (NASDAQ:VTGN) is also among the best penny stocks. TheFly reported on May 12 that VTGN shared early findings from the continuing extension phase of its Phase 3 PALISADE-3 study evaluating fasedienol for acute social anxiety disorder. Participants who entered the extension study used 3.2 micrograms of fasedienol as needed in real-world anxiety-triggering situations for up to 12 months, with dosing allowed multiple times daily and no new safety concerns observed. Exploratory outcomes over four months showed improvement on clinician-rated Liebowitz Social Anxiety Scale and Social Phobia Inventory measures. Overall tolerability remained strong with no identified adverse trends, and patients reported gradual benefit over time, supporting continued development of intranasal therapy for anxiety treatment. Previously, on May 8, Vistagen Therapeutics, Inc. (NASDAQ:VTGN) reported that the final participant completed the last scheduled visit in the randomized, double-blind, placebo-controlled phase of its PALISADE-4 Phase 3 trial evaluating fasedienol nasal spray for acute social anxiety disorder. The study’s open-label extension is continuing. PALISADE-4 is a U.S. multicenter trial assessing the single-dose treatment effect of fasedienol on anxiety symptoms during a controlled public speaking challenge, using the Subjective Units of Distress Scale as the primary endpoint. Eligible participants from the blinded phase who joined the extension may continue using the therapy in everyday situations up to six times daily for as long as 12 months. Vistagen Therapeutics, Inc. (NASDAQ:VTGN) is a clinical-stage biopharmaceutical company based in South San Francisco. It develops rapid-onset intranasal CNS therapies (“pherines”) for psychiatric and neurological disorders. While we acknowledge the potential of VTGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 8 Most Oversold Large Cap Stocks to Buy and 10 Best Cancer Stocks to Buy for the Long Term. Disclosure: None. Follow Insider Monkey on Goog...

This article first appeared on GuruFocus. Release Date: February 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Vistagen Therapeutics Inc (NASDAQ:VTGN) completed the randomized portion of the Palisade 3 phase 3 trial in social anxiety disorder, marking significant progress in their clinical stage neuroscience program. The company is implementing innovative approaches, including artificial intelligence and machine learning, to analyze data from their studies, potentially enhancing their statistical models and regulatory strategy. Vistagen Therapeutics Inc (NASDAQ:VTGN) is advancing their women's health program with the planned submission of an investigational new drug application for Raficione, targeting vasomotor symptoms due to menopause. The company has $61.8 million in cash equivalents and marketable securities, providing a solid financial position to support ongoing and future projects. Vistagen Therapeutics Inc (NASDAQ:VTGN) is focused on addressing significant unmet needs in social anxiety disorder and women's health, guiding their long-term strategic efforts. The Palisade 3 trial experienced a higher placebo response, necessitating refinements and retraining to mitigate this issue in the ongoing Palisade 4 trial. The company acknowledges the inherent risks and uncertainties in forward-looking statements, which could lead to material differences in actual results. Vistagen Therapeutics Inc (NASDAQ:VTGN) faces potential regulatory challenges, as any changes to their statistical analysis plan (SAP) would require resubmission and alignment with the FDA. The open label extension studies, while providing valuable insights, are inherently uncontrolled and exploratory, which may limit the robustness of the data. The company's reliance on AI and machine learning for data analysis introduces uncertainty, as the identification of covariants and their impact on study outcomes is not guaranteed. Warning! GuruFocus has detected 3 Warning Signs with VTGN. Is VTGN fairly valued? Test your thesis with our free DCF calculator. Q: In the Palisade 3 data, how did the individual curves look at every interval out to 5 minutes? Was there a separation at all across any of those time points, with fazodinol versus placebo? A: At this point, we've only released the top-line results publicly. We are still analyzing t...

Management attributed the PALISADE-3 top-line results to a higher-than-expected placebo response compared to the successful PALISADE-2 study. The company is utilizing proprietary AI and machine learning technologies to analyze data across all PALISADE studies to identify predictors of drug response and nonspecific placebo effects. Operational refinements for the ongoing PALISADE-4 trial include site rationalization, retraining on protocol adherence, and enhanced audio monitoring to minimize subject comfort that could drive placebo responses. Strategic focus has shifted toward a 'weight of evidence' approach, aiming to present the totality of data from both randomized and open-label trials to the FDA. Company-wide cash preservation measures were implemented during the quarter to extend the operational runway and maintain flexibility for the Pherin pipeline. The open-label extension studies are being used to gather real-world evidence on fasedienol usage patterns and long-term safety in daily anxiety-provoking situations. Management is evaluating potential modifications to the Statistical Analysis Plan (SAP) for PALISADE-4 to include covariates identified through AI analysis, pending FDA alignment. A successful PALISADE-4 trial, combined with PALISADE-2, is intended to serve as the basis for a New Drug Application (NDA) for the acute treatment of social anxiety disorder. The company plans to submit a U.S. Investigational New Drug (IND) application for refisolone in the first half of 2026 to support Phase II development for menopause symptoms. Future regulatory discussions will likely incorporate innovative statistical models that account for explanatory variables discovered during the current cross-study analytical work. Current cash reserves of $61.8 million are expected to be sufficient to complete the randomized portion of the PALISADE-4 trial. Official USAN adoption of the name 'refisolone' for the PH80 candidate marks a transition toward formal clinical development in women's health. The company acknowledged that if PALISADE-4 fails to separate from placebo, the regulatory path would rely entirely on the 'weight of evidence' from the broader program data. Management noted that any changes to the SAP must be finalized and socialized with the FDA before the PALISADE-4 database lock to remain valid for regulatory review. Our analysts just identified a stock...

PALISADE-4 Phase 3 Trial of fasedienol for acute treatment of Social Anxiety Disorder proceeding, with topline results from the randomized portion of the trial expected in the first half of 2026 SOUTH SAN FRANCISCO, Calif., February 12, 2026--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today reported financial results for its fiscal year 2026 third quarter ended December 31, 2025, and provided a corporate update. "We have reviewed available data from PALISADE-3 and implemented moderate refinements, including retraining, site rationalization, and operational enhancements to our ongoing PALISADE-4 Phase 3 trial. We expect topline results from the randomized portion of PALISADE-4 in the first half of 2026," said Shawn Singh, President and Chief Executive Officer of Vistagen. "With outside collaborators and their proprietary artificial intelligence and machine learning methodologies, we are conducting an extensive analysis across all available PALISADE Program datasets to potentially inform modifications to the statistical analysis plan for PALISADE-4 and our regulatory strategy." "We have implemented targeted, company-wide cash preservation initiatives and remain committed to disciplined capital allocation and preserving strategic flexibility as we approach key clinical milestones in 2026. We believe we are well-positioned to complete PALISADE-4 and advance preparations and planning for the pherine pipeline." Program Updates Fasedienol for the Acute Treatment of Social Anxiety Disorder The Company expects topline results for 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. 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 r...

This article first appeared on GuruFocus. Vistagen Therapeutics Inc (NASDAQ:VTGN) is set to release its Q3 2026 earnings on Feb 12, 2026. The consensus estimate for Q3 2026 revenue is $0.37 million, and the earnings are expected to come in at -$0.44 per share. The full year 2026's revenue is expected to be $0.89 million and the earnings are expected to be -$1.76 per share. More detailed estimate data can be found on the Forecast page. Warning! GuruFocus has detected 3 Warning Signs with VTGN. Is VTGN fairly valued? Test your thesis with our free DCF calculator. Over the past 90 days, revenue estimates for Vistagen Therapeutics Inc (NASDAQ:VTGN) have increased from $0.52 million to $0.89 million for the full year 2026 and from $2.97 million to $3.18 million for 2027. Concurrently, earnings estimates have declined from -$1.62 per share to -$1.76 per share for the full year 2026, while they have increased from -$1.66 per share to -$1.25 per share for 2027. In the previous quarter ending on 2025-09-30, Vistagen Therapeutics Inc's (NASDAQ:VTGN) actual revenue was $0.26 million, which beat analysts' revenue expectations of $0.24 million by 6.17%. Vistagen Therapeutics Inc's (NASDAQ:VTGN) actual earnings were -$0.54 per share, which missed analysts' earnings expectations of -$0.48 per share by -13.45%. After releasing the results, Vistagen Therapeutics Inc (NASDAQ:VTGN) was flat in one day. Based on the one-year price targets offered by 4 analysts, the average target price for Vistagen Therapeutics Inc (NASDAQ:VTGN) is $3.73 with a high estimate of $12.00 and a low estimate of $0.90. The average target implies an upside of 556.16% from the current price of $0.57. Based on GuruFocus estimates, the estimated GF Value for Vistagen Therapeutics Inc (NASDAQ:VTGN) in one year is $0.00, suggesting a downside of -100.00% from the current price of $0.57. Based on the consensus recommendation from 5 brokerage firms, Vistagen Therapeutics Inc's (NASDAQ:VTGN) average brokerage recommendation is currently 3.0, indicating a "Hold" status. The rating scale ranges from 1 to 5, where 1 signifies strong buy, and 5 denotes sell.

SOUTH SAN FRANCISCO, Calif., February 04, 2026--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced it will host a conference call and webcast on Thursday, February 12, 2026, at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) to report results for its fiscal year 2026 third quarter ended December 31, 2025, and provide a corporate update. The conference call is being webcast live, and a link can be found under "Events" in the Investors section of the Company's website. Please click on the webcast link and follow the prompts for registration and access at least 10 minutes before the call. The webcast will be archived on Vistagen’s website shortly after the call and will be available for at least 90 days. For participants interested in joining the call via dial-in, please follow the link below to pre-register. After registering, you will receive access to access details via email. https://register-conf.media-server.com/register/BI3bf0ee6127db48dcbce4d11a90b295b4 About Vistagen Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company leveraging a deep understanding of nose-to-brain neurocircuitry to develop and commercialize a new class of rapid-onset neurocircuitry-focused intranasal product candidates called pherines. Vistagen’s pherine product candidates are designed to achieve therapeutic benefits without requiring absorption into the blood or uptake into the brain, giving them the potential to be a safer alternative to other pharmacological options if successfully developed and approved. Vistagen’s pherine pipeline currently consists of five investigational product candidates focused on improving the current standard of care for multiple highly prevalent indications, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) due to menopause. Connect at www.Vistagen.com. View source version on businesswire.com: https://www.businesswire.com/news/home/20260204838058/en/ Contacts Investor Inquiries: Mark A. McPartland [email protected] Media Inquiries: Michelle P. Wellington [email protected]

Study did not demonstrate statistically significant improvement on primary endpoint of reduction in anxiety as measured by SUDS scores compared to placebo Favorable safety and tolerability data were consistent with previous studies Company’s cash preservation measures expected to provide runway into 2027 SOUTH SAN FRANCISCO, Calif., December 17, 2025--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced that the PALISADE-3 Phase 3 study of intranasal fasedienol for the acute treatment of social anxiety disorder did not demonstrate a statistically significant improvement on the primary endpoint of change on the Subjective Units of Distress Scale (SUDS). The trial did not achieve its primary endpoint, as measured by the least squares (LS) mean change from baseline on the Subjective Units of Distress Scale (SUDS) score for fasedienol (13.6 +/-1.54 standard error, SE) compared with placebo (14.0 +/-1.51 SE), a LS mean difference of 0.4 (p = not significant). There was no treatment difference between fasedienol and placebo for the secondary endpoints. The favorable safety data of fasedienol were consistent with previous clinical trials. "We are disappointed by the unexpected results of this public speaking challenge trial, which are inconsistent with positive outcomes observed in Phase 2 and our PALISADE-2 Phase 3 study," said Shawn Singh, President and Chief Executive Officer of Vistagen. "We are thoroughly reviewing the results of the study, evaluating the potential impact of the results on our ongoing studies and plan to seek feedback from the FDA. In parallel, we are implementing company-wide cash preservation measures in an effort to enhance operational efficiency, provide cash runway into 2027, and maintain strategic optionality across our pherine pipeline. I’d like to thank the patients, coordinators, and investigators, as well as the development team at Vistagen, for their time and efforts in conducting this trial." About PALISADE-3 PALISADE-3 is a U.S. multi-center, randomized, double-blind, placebo-controlled Phase 3 public speaking challenge study designed to evaluate the efficacy and safety of a single dose of fasedienol in reducing anxiety symptoms dur...

PALISADE-3 Phase 3 Public Speaking Challenge Study of Fasedienol for the Acute Treatment of Social Anxiety Disorder is Complete; Topline results expected by calendar year end SOUTH SAN FRANCISCO, Calif., November 13, 2025--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today reported financial results for its fiscal year 2026 second quarter ended September 30, 2025, and provided a corporate update. "As we conclude the second quarter of our fiscal year, we are encouraged by our progress and remain confident in the path ahead," said Shawn Singh, President and Chief Executive Officer of Vistagen. "We are on track to report topline data from the randomized portion of our PALISADE-3 Phase 3 trial of fasedienol for the acute treatment of social anxiety disorder this quarter, followed by the randomized portion of our PALISADE-4 Phase 3 trial in 2026. We have built strong momentum toward the primary goal of our PALISADE program, developing what we hope could be the first FDA-approved acute treatment of social anxiety disorder for the 30 million adults living with this serious and potentially life-threatening condition." Program Highlights Fasedienol for the Acute Treatment of Social Anxiety Disorder Earlier this month, Vistagen announced that the last patient completed the randomized, double-blinded portion of its PALISADE-3 Phase 3 clinical trial evaluating fasedienol for the acute treatment of social anxiety disorder. Topline results from this randomized portion of the PALISADE-3 Phase 3 trial are expected in the fourth quarter of this calendar year. A duplicate and concurrent Phase 3 trial, PALISADE-4, involves the same public speaking challenge study design as PALISADE-3. Topline results from the randomized, double-blinded portion PALISADE-4 are expected in the first half of 2026. Corporate Highlights In October, Vistagen announced the appointment of Mr. Paul Edick to its Board of Directors. Mr. Edick was also appointed to serve on Vistagen’s Audit and Compensation Committees. Financial Results for Fiscal Year 2026 Second Quarter Ended September 30, 2025 Research and development (R&D) expense R&D expense was $15.9 million for the three months ended September 30, 2025, as co...