Current Report · Items 8.01, 9.01 · 8-K
Vistagen Therapeutics, Inc.
VTGNNASDAQEQUITYCurrent
Other Events
Item 8.01 Other Events On September 22, 2026, Vistagen Therapeutics, Inc. (the “Company”) issued a press release to announce preliminary positive data from the open-label extension (“OLE”) portion of its PALISADE-4 Phase 3 study of fasedienol 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.…
Filed Sep 22, 2026Accepted Sep 22, 2026, 4:22 PM EDTCIK 1411685Accession 0001628280-26-063046
Company context
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 most advanced intranasal pherine product candidates are fasedienol for the acute treatment of social anxiety disorder, itruvone for treatment of major depressive disorder, and refisolone for treatment of vasomotor symptoms (hot flashes) due to menopause. Connect at www. Vistagen.com
Current securities
Registered securities in this filing
Vistagen Therapeutics, Inc. · 8-K · Filed 2026-09-22
As filed in this accession. Current/historical status below comes from the governed listing record; the cover itself remains exact to this filing.
Common Stock, par value $0.001 per share
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Filing context
Context: c-1
Dimensions: Not supplied
Accession 000162828026063046 · 1 registered-security cover member
Read the exact SEC filing ↗Disclosure sections
Items 8.01, 9.01Select an item to read the extracted section. The as-filed document remains the primary evidence.
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events
On September 22, 2026, Vistagen Therapeutics, Inc. (the “Company”) issued a press release to announce preliminary positive data from the open-label extension (“OLE”) portion of its PALISADE-4 Phase 3 study of fasedienol 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.
Forward-looking Statements
This Current Report on Form 8-K and the exhibit filed herewith contains certain forward-looking statements within the meaning of the federal securities laws, including, without limitation, statements regarding indications of improvements observed over time by patients in the OLE portion of PALISADE-4; the ability of preliminary findings from the OLE portion of PALISADE-4 to support potential clinical meaningfulness; indications of safety data from the OLE portion of PALISADE-4; the Company’s belief that the results of the PALISADE-4 OLE are consistent with, supportive of, or complementary to previously reported fasedienol clinical data; the Company’s other beliefs about the understandings drawn from the preliminary OLE data and other fasedienol clinical studies; the Company’s plans to meet with the U.S. Food and Drug Administration (“FDA”) during the current quarter and the potential regulatory path forward for fasedienol; and the Company’s belief that its fasedienol development program could support a potential New Drug Application submission to the FDA for the acute treatment of social anxiety disorder. 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. Risks that may impact the outcome of these forward-looking statements are more fully discussed in the section entitled “Risk Factors” in the Company's Quarterly Report on Form 10-Q for the period ended June 30, 2026, Annual Report on Form 10-K for the fiscal year ended March 31, 2026, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the SEC. The Company's SEC filings are available on the SEC's website at www.sec.gov. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this report and should not be relied upon as representing the Company's views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements other than as may be required by law. If the Company does update one or more forward-looking statements, no inference should be made that the Company will make additional updates with respect to those or other forward-looking statements.