Vistagen (VTGN) completes PALISADE-4 randomized phase, eyes Q2 2026 data
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Vistagen Therapeutics reports that the last patient has completed the last visit in the randomized, double-blind, placebo-controlled portion of PALISADE-4, its U.S. Phase 3 trial of intranasal fasedienol for the acute treatment of social anxiety disorder. The open-label extension remains ongoing, allowing continued real-world use. Topline results from the randomized portion are expected in the second quarter of 2026.
The company refined the PALISADE-4 statistical analysis plan to incorporate each participant’s pre-dose Subjective Units of Distress Scale score as a baseline covariate, and the FDA indicated it has no comments on these refinements. Fasedienol has FDA Fast Track designation, and Vistagen believes PALISADE-4, if successful and combined with prior Phase 3 data, could support a future New Drug Application for social anxiety disorder.
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Insights
Completion of randomized PALISADE-4 visits sets up key Phase 3 readout in Q2 2026.
Vistagen has finished patient visits in the randomized portion of PALISADE-4, a Phase 3 trial of intranasal fasedienol for acute treatment of social anxiety disorder. The open-label extension continues, providing longer-term usage data in real-world-like conditions.
The company refined the statistical analysis plan to adjust for each participant’s pre-dose anxiety level using the Subjective Units of Distress Scale, aligning with FDA covariate guidance. The FDA stated it has no comments on these refinements, reducing procedural risk around the analysis approach.
Topline randomized results are expected in the second quarter of 2026, making that readout a key inflection for the fasedienol program. Vistagen believes PALISADE-4, together with earlier Phase 3 data, could support a potential New Drug Application if outcomes are sufficiently positive, but clinical and regulatory uncertainties remain inherent.
8-K Event Classification
2 items: 8.01, 9.01
2 items
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Topline results timing: second quarter of 2026
Social anxiety prevalence: over 30 million adults in the U.S.
Fasedienol daily dosing limit: up to six times per day
+2 more
5 metrics
Topline results timing
second quarter of 2026
Expected for randomized portion of PALISADE-4
Social anxiety prevalence
over 30 million adults in the U.S.
Estimated adults affected by social anxiety disorder
Fasedienol daily dosing limit
up to six times per day
Allowed in open-label extension of PALISADE-4
Open-label extension duration
up to twelve months
Maximum treatment duration in PALISADE-4 OLE
FDA designation
Fast Track
Granted for fasedienol in social anxiety disorder
Key Terms
PALISADE-4, Subjective Units of Distress Scale (SUDS), open label extension (OLE), Fast Track designation, +2 more
6 terms
PALISADE-4 medical
"the randomized, double-blind, placebo-controlled portion of PALISADE-4, the Company’s Phase 3 clinical trial"
Subjective Units of Distress Scale (SUDS) medical
"using the Subjective Units of Distress Scale (SUDS) as the primary endpoint"
A subjective units of distress scale (SUDS) is a simple self‑reported measure where a person rates their current emotional discomfort on a numeric scale (commonly 0 for no distress up to 100 for extreme distress), like using a thermometer for feelings. Investors should care because SUDS often appears in clinical studies and therapy evaluations to show whether a treatment or intervention relieves symptoms; consistent changes can influence regulatory decisions, payer coverage and market acceptance of mental‑health products.
open label extension (OLE) medical
"The open label extension (OLE) portion of the PALISADE-4 study remains ongoing."
An open label extension (OLE) is a follow-up phase of a clinical trial where participants continue receiving a study treatment and both researchers and patients know what drug is being given. It matters to investors because OLEs produce longer-term safety and effectiveness information, help retain trial participants, and can strengthen regulatory filings or commercial plans—like a long-term test drive that shows whether a product performs safely and reliably over time.
Fast Track designation regulatory
"The FDA has granted Fast Track designation for the development of fasedienol"
A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.
New Drug Application (NDA) regulatory
"could provide substantial evidence of fasedienol’s effectiveness in support of a potential New Drug Application (NDA) submission"
A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.
pherine product candidates medical
"a new class of intranasal product candidates called pherines"
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) of the SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): May 8, 2026
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification Number) | ||||||
(Address of principal executive offices)
(650 ) 577-3600
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2)
Emerging Growth Company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act o
Item 8.01 Other Events.
On May 8, 2026, Vistagen Therapeutics, Inc. (the “Company”) issued a press release to announce, among other things, that the last patient has completed their last visit in the randomized, double-blind, placebo-controlled portion of PALISADE-4, the Company’s Phase 3 clinical trial evaluating fasedienol nasal spray for the acute treatment of social anxiety disorder. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits Index
| Exhibit No. | Description | |||||||
| 99.1 | Press Release issued by Vistagen Therapeutics, Inc., dated May 8, 2026 | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Vistagen Therapeutics, Inc. | ||||||||
| Date: May 8, 2026 | By: | /s/ Shawn K. Singh | ||||||
| Shawn K. Singh President and Chief Executive Officer | ||||||||
EXHIBIT 99.1
Vistagen Announces Completion of Last Patient Visit in PALISADE-4 Phase 3 Public Speaking Challenge Study of Fasedienol for Acute Treatment of Social Anxiety Disorder
Topline results for the randomized portion of PALISADE-4 are expected in the second quarter of 2026
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)— May 8, 2026, 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 last patient has completed the last visit in the randomized, double-blind, placebo-controlled portion of PALISADE-4, the Company’s Phase 3 clinical trial evaluating fasedienol nasal spray for the acute treatment of social anxiety disorder. The open label extension (OLE) portion of the PALISADE-4 study remains ongoing.
“The completion of the randomized portion of PALISADE-4 is another important step for our fasedienol Phase 3 program in social anxiety disorder, and we expect to announce topline results this quarter,” said Shawn Singh, President and Chief Executive Officer. “We extend our sincere thanks to the participants, clinical investigators, site staff, and contract research organization whose hard work, collaboration, and commitment brought this portion of the study to completion.”
PALISADE-4 is a U.S. multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical study designed to evaluate the efficacy, safety, and tolerability of a single dose of fasedienol in reducing anxiety symptoms in adults with social anxiety disorder during a simulated anxiety-provoking public speaking challenge conducted in a clinical setting using the Subjective Units of Distress Scale (SUDS) as the primary endpoint. Participants in the randomized portion of PALISADE-4 who chose to continue with the OLE portion of the study can use fasedienol in their daily lives up to six times per day for up to twelve months.
As previously announced, Vistagen continues to analyze datasets from the randomized portions of the PALISADE-1, PALISADE-2, and PALISADE-3 Phase 3 studies for fasedienol for the acute treatment of social anxiety disorder, including with the assistance of collaborators and proprietary artificial intelligence and machine learning methodologies. Based on these analyses, Vistagen refined the statistical analysis plan (SAP) for PALISADE-4 to incorporate each participant’s distress level immediately prior to dosing, as measured by the SUDS (pre-IP SUDS), into the primary efficacy analysis. While there is no guarantee the Company’s refinements to the PALISADE-4 SAP will result in a positive outcome for the study, Vistagen believes the refined SAP reflects established statistical principles supporting the use of baseline covariates in randomized clinical trials consistent with U.S. Food and Drug Administration (FDA) guidance regarding adjustments for covariates (Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products, May 2023). The FDA has informed the Company that it has no comments on the refinements to the PALISADE-4 SAP. No changes were made to the PALISADE-4 clinical study protocol as a result of the ongoing dataset analyses or refinement of the PALISADE-4 SAP.
The FDA has granted Fast Track designation for the development of fasedienol for the acute treatment of social anxiety disorder. Vistagen believes that PALISADE-4, if successful, together with the positive results from its PALISADE-2 Phase 3 trial and further evidence Vistagen plans to generate to support the clinical meaningfulness of the duration and magnitude of effect of fasedienol, could provide substantial evidence of fasedienol’s effectiveness in support of a potential New Drug Application (NDA) submission to the FDA for the acute treatment of social anxiety disorder.
About Social Anxiety Disorder
Social anxiety disorder is a highly prevalent, serious, and sometimes life-threatening psychiatric mental health disorder affecting over 30 million adults in the U.S. While often experienced on a long-term basis, social anxiety disorder can manifest acutely when triggered by anxiety-provoking social and performance situations in daily life, causing anxiety, distress, and the fear of embarrassment, judgment, and humiliation. Social anxiety disorder can also significantly disrupt social life and hinder occupational functioning, as well as increase the risk of depression and substance use disorders, suicidal ideation, and suicide.
About Fasedienol Nasal Spray for Acute Treatment of Social Anxiety Disorder
Fasedienol is Vistagen’s lead neurocircuitry-focused pherine product candidate in U.S. Phase 3 clinical development for the acute treatment of anxiety in adults with social anxiety disorder. Fasedienol's proposed mechanism of action (MOA) is fundamentally differentiated from all FDA-approved anti-anxiety medications. When administered intranasally in microgram-level doses, neurocircuitry-focused fasedienol modulates the nasal-limbic amygdala fear and anxiety neurocircuits involved in the pathophysiology of social anxiety disorder. Fasedienol is pharmacologically active without requiring apparent systemic absorption or uptake into the brain to achieve its rapid-onset anxiolytic effects. Fasedienol also has no observed binding on certain cellular receptors isolated from the brain that are associated with known drug abuse liability potential (for example, dopamine and opiate receptors) when activated by certain other pharmaceutical compounds for neuropsychiatric and neurological disorders. Unlike benzodiazepines, fasedienol has no observed potentiation of GABA-A receptors. Because of its innovative non-systemic neurocircuitry-focused proposed MOA, Vistagen believes fasedienol has the potential to achieve rapid-onset anxiolytic effects for individuals with social anxiety disorder on an acute, as-needed basis, with a significantly reduced risk of unwanted side effects and safety concerns, such as potential drug-drug interactions, abuse, misuse, and addiction, associated with certain current oral and other systemically absorbed neuropsychiatric pharmaceuticals that act directly on neurons in the brain and are sometimes prescribed off-label for the acute treatment of social anxiety disorder.
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 clinical-stage 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.
Forward-looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws, including, without limitation, statements regarding the expected timing for topline results from the randomized portion of PALISADE-4; the design of the PALISADE-4 clinical trial and its ability to evaluate the efficacy and safety of fasedienol to reduce anxiety symptoms in patients with social anxiety disorder; continued analysis of datasets from the PALISADE-1, PALISADE-2 and PALISADE-3 Phase 3 studies; the refinements to the PALISADE-4 SAP, and the ability of the refined PALISADE-4 SAP to result in a positive outcome for PALISADE-4; Vistagen’s belief that the refined SAP reflects established statistical principles supporting the use of baseline covariates in randomized clinical trials and is consistent with publicly available FDA guidance; Vistagen’s belief that successful results from its PALISADE Phase 3 development program, including PALISADE-4, could provide substantial evidence of fasedienol’s effectiveness in support of a potential NDA submission to the FDA; fasedienol’s potential to achieve rapid-onset anxiolytic effects for individuals with social anxiety disorder on an acute, as-needed basis. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “project,” “outlook,” “strategy,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “strive,” “goal,” “continue,” “likely,” “will,” “would” and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based upon estimates and assumptions that, while
considered reasonable by Vistagen and its management, are inherently uncertain. As with all pharmaceutical product candidates, there are substantial risks and uncertainties in the process of development and potential commercialization, and actual results or developments may differ materially from those projected or implied in these forward-looking statements. There can be no guarantee that any of Vistagen’s pherine product candidates, including fasedienol, will successfully complete ongoing or future clinical trials within estimated timelines or at all, receive regulatory approval or be commercially successful. Other factors that may cause such a difference , include, without limitation, risks and uncertainties relating to conducting and/or completing ongoing clinical trials, including those that are a part of Vistagen’s Phase 3 development of fasedienol in the PALISADE program, as currently expected or at all; submission of a NDA to the FDA for any of Vistagen's product candidates, including fasedienol; the ability of any clinical trial information submitted by Vistagen to the FDA to successfully support an NDA; Vistagen's dependence on third-party collaborators for the development, regulatory approval, and/or commercialization of its product candidates and other aspects of its business, which are outside of Vistagen's full control; risks associated with current and potential future healthcare reforms; the scope and enforceability of Vistagen’s patents, including patents related to Vistagen’s fasedienol and other pherine product candidates; fluctuating costs of materials and other resources and services required to conduct Vistagen’s ongoing and/or planned clinical and non-clinical trials; market conditions; the impact of general economic, industry or political conditions in the United States or internationally; and other technical and unexpected hurdles in the development, manufacture and commercialization of Vistagen’s product candidates. These risks are more fully discussed in the section entitled “Risk Factors” in Vistagen’s Annual Report on Form 10-K for the fiscal year ended March 31, 2025, and Quarterly Report on Form 10-Q for the period ended December 31, 2025, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the U.S. Securities and Exchange Commission (SEC). Vistagen’s SEC filings are available on the SEC’s website at sec.gov. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release and should not be relied upon as representing Vistagen’s views as of any subsequent date. Vistagen explicitly disclaims any obligation to update any forward-looking statements other than as may be required by law. If Vistagen does update one or more forward-looking statements, no inference should be made that Vistagen will make additional updates with respect to those or other forward-looking statements.
Investor Inquiries:
IR@vistagen.com
Media Inquiries:
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FAQ
What did Vistagen Therapeutics (VTGN) announce about its PALISADE-4 trial?
Vistagen announced that the last patient completed the last visit in the randomized portion of PALISADE-4, its Phase 3 trial of fasedienol nasal spray for acute treatment of social anxiety disorder. The open-label extension continues, and topline randomized results are expected in the second quarter of 2026.
When are PALISADE-4 topline results expected for Vistagen (VTGN)?
Topline results from the randomized, double-blind, placebo-controlled portion of PALISADE-4 are expected in the second quarter of 2026. These data will evaluate the efficacy, safety, and tolerability of a single dose of fasedienol in adults with social anxiety disorder during a simulated public speaking challenge.
How is the PALISADE-4 Phase 3 study for Vistagen’s fasedienol designed?
PALISADE-4 is a U.S. multi-center, randomized, double-blind, placebo-controlled Phase 3 study. It assesses a single intranasal dose of fasedienol in adults with social anxiety disorder during a simulated public speaking challenge, using the Subjective Units of Distress Scale (SUDS) as the primary efficacy endpoint for anxiety reduction.
What statistical changes did Vistagen (VTGN) make to the PALISADE-4 analysis?
Vistagen refined the PALISADE-4 statistical analysis plan to include each participant’s pre-dose Subjective Units of Distress Scale score as a baseline covariate in the primary efficacy analysis. The FDA informed the company it has no comments on these refinements, which Vistagen believes align with FDA covariate adjustment guidance.
Does fasedienol for social anxiety disorder have any special FDA designation?
Yes. The FDA has granted Fast Track designation for fasedienol’s development for the acute treatment of social anxiety disorder. Fast Track is intended to facilitate development and expedite review of drugs that address serious conditions and fill an unmet medical need, potentially enabling more frequent FDA interactions.
How prevalent is social anxiety disorder targeted by Vistagen’s fasedienol?
Vistagen notes that social anxiety disorder affects over 30 million adults in the United States. It is described as a serious psychiatric condition that can disrupt social and occupational functioning and increase risks of depression, substance use disorders, suicidal ideation, and suicide, highlighting the need for improved acute treatments.