Every 8-K that Vistagen Therapeutics Inc (VTGN) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow VTGN and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full VTGN filings page.
Vistagen Therapeutics reported fiscal 2027 first quarter results and a corporate update centered on its intranasal pherine pipeline. Revenue was $1.5 million, mainly from recognizing $1.2 million tied to the expiration of an exclusivity period under a Fuji Pharma agreement. Research and development expense was $10.9 million and general and administrative expense was $3.9 million, both modestly lower than a year earlier as the company executes cash preservation initiatives.
Net loss was $13.0 million, improving from $15.1 million in the prior-year quarter. Cash, cash equivalents, and marketable securities totaled $31.7 million as of June 30, 2026, which Vistagen believes will fund operations into 2027 but not for more than a year from now. Clinically, the lead candidate fasedienol did not meet the primary endpoint in the overall PALISADE-4 Phase 3 population, but exploratory and post-hoc analyses in patients with very severe social anxiety showed nominally statistically significant improvements versus placebo, with a favorable safety profile. The company has achieved ICH-recommended exposure levels and is planning FDA discussions on a potential Phase 3 registrational path, while also advancing itruvone and refisolone and adding experienced neuroscience leadership.
Vistagen Therapeutics, Inc. reported topline data from an exploratory, three-arm, randomized, double-blind, placebo-controlled Phase 2 study (N=61) of intranasal fasedienol for the acute treatment of social anxiety disorder during a public speaking challenge, comparing two 3.2 µg doses ten minutes apart with a single 3.2 µg dose and placebo.
The study met its safety objective, with repeat dosing showing safety and tolerability comparable to single-dose administration and no new safety findings. On the primary endpoint, LS mean change in Subjective Units of Distress (SUDS) from baseline to challenge, pooled fasedienol reduced SUDS by 15.0 versus 6.8 for placebo, but between-group differences were not statistically significant. In a prespecified subgroup with very severe social anxiety (Liebowitz Social Anxiety Scale ≥95), pooled fasedienol showed a larger SUDS reduction of 16.2 versus 1.6 for placebo with nominal p=0.04. Responder rates on CGI-I and PGI-C were directionally higher for fasedienol, with repeat-dose CGI-I responders at 47% versus 19% for placebo. An exploratory analysis of anticipatory anxiety found pooled fasedienol cut SUDS by 13.8 versus 0.9 for placebo (nominal p=0.03), with repeat dosing at 19.3 (p=0.01). These exploratory findings, which include nominally statistically significant effects in very severe patients, will inform upcoming discussions with the FDA about a potential registrational pathway for fasedienol, subject to the cautions and risks described.
Vistagen Therapeutics, Inc. reports that Nasdaq has granted a 180-day extension, until February 1, 2027, to regain compliance with the $1.00 per share Minimum Bid Price Requirement for its common stock to remain listed on the Nasdaq Capital Market.
The extension does not immediately affect the stock’s listing, which remains fully effective. Vistagen has informed Nasdaq it intends to cure the deficiency within the extension period. If compliance is not restored by that deadline, the common stock would be subject to delisting, and any appeal to a Nasdaq Hearing Panel is not assured of success.
Vistagen Therapeutics, Inc. appointed Douglas J. Williamson, M.D. to its Board of Directors on July 29, 2026. Upon joining the board, he received stock options under the Director Compensation Plan to purchase up to 40,826 shares of common stock at an exercise price of $0.2433 per share, equal to the closing price on his appointment date. The options have a ten-year term and vest in equal annual installments over a three-year period beginning on the one-year anniversary of the Effective Date, becoming fully vested on the three-year anniversary. He will also receive annual cash compensation and additional equity awards under the plan.
Vistagen and Dr. Williamson entered into an Indemnification Agreement under which the company will indemnify him to the fullest extent permitted under Nevada law and advance certain expenses related to covered proceedings. Vistagen describes itself as a late clinical-stage biopharmaceutical company developing intranasal pherine product candidates, including fasedienol in U.S. Phase 3 development for social anxiety disorder and, in Phase 2 development, itruvone for major depressive disorder and refisolone for vasomotor symptoms due to menopause.
Vistagen Therapeutics reported topline results from its PALISADE-4 Phase 3 trial of intranasal fasedienol for social anxiety disorder. In the full study population of 238 adults, fasedienol did not meet the primary endpoint, with a least squares mean SUDS score change of -9.5±1.7 versus -11.4±1.7 for placebo, a difference of 1.9 (p=0.427). Secondary endpoints also showed no treatment difference.
Safety and tolerability were favorable and consistent with prior placebo-controlled trials. In a post-hoc subgroup of 123 patients with very severe social anxiety (baseline LSAS ≥95), fasedienol showed a nominally statistically significant SUDS improvement of -12.8±3.4 versus -3.7±3.4 for placebo, a difference of -9.1 (p=0.036). Vistagen plans to meet with the FDA to discuss a potential registrational path focused on overall treatment of social anxiety disorder over time, supported by a planned multi-dose Phase 3 trial using LSAS as the primary endpoint and confirmatory evidence from the broader PALISADE program. The company continues to expect its cash resources to fund operations into 2027.
Vistagen Therapeutics, Inc. announced that two members of its Board of Directors, Ms. Margaret FitzPatrick and Dr. Joanne Curley, have chosen not to stand for re-election at the company’s 2026 Annual Meeting of Stockholders. Both directors will continue to serve on the board until their current terms end at the 2026 Annual Meeting. The company’s common stock continues to trade on the Nasdaq Capital Market under the symbol VTGN.
Vistagen Therapeutics reported a fiscal 2026 net loss of $69.7 million, up from $51.4 million, as it increased investment in its late-stage pherine pipeline. Research and development expense rose to $55.0 million, while general and administrative expense was $18.4 million.
Revenue was $1.3 million, primarily from sublicenses and other sources. Cash, cash equivalents, and marketable securities totaled $45.4 million as of March 31, 2026, and the company expects this to fund operations into 2027. Vistagen completed the randomized portion of its PALISADE-4 Phase 3 trial of fasedienol in social anxiety disorder, achieved ICH E1 safety exposure recommendations, reported preliminary positive data from the PALISADE-3 open-label extension, and received an FDA “Study May Proceed” letter to advance refisolone for menopausal vasomotor symptoms.
Vistagen Therapeutics reported that its clinical program for fasedienol nasal spray for acute treatment of social anxiety disorder has now met the minimum patient exposure levels recommended under ICH E1 safety guidance for long-term treatment of non-life-threatening conditions.
As of May 31, 2026, the company estimates that more than 1,500 subjects have received at least one dose of fasedienol, with over 300 exposed for at least six months and over 100 for at least 12 months, based on open-label safety studies and extension phases of its PALISADE-3, PALISADE-4 and repeat-dose trials.
Vistagen cautions that it has not yet aligned with the FDA on specific exposure requirements for a potential New Drug Application. It expects topline Phase 3 PALISADE-4 results in the second quarter of 2026 and topline Phase 2 repeat-dose results in the third quarter of 2026, which it believes could help support a potential future U.S. NDA submission if outcomes are successful.
Vistagen Therapeutics appointed Angel S. Angelov, M.D., MBA as Chief Medical Officer effective May 18, 2026. He brings over two decades of clinical development and medical affairs experience from roles at companies including Karuna Therapeutics, Neurocrine Biosciences, Novartis and Teva, as well as academic positions.
His compensation includes a starting annual base salary of $425,000, a $50,000 signing bonus paid in two tranches, and eligibility for an annual discretionary cash bonus targeted at 45% of base salary. He also received an inducement stock option grant to purchase 150,000 shares at an exercise price of $0.5955 per share, vesting over four years, in accordance with Nasdaq Listing Rule 5635(c)(4). Vistagen also entered into an indemnification agreement with him and issued a press release describing his appointment and the company’s late clinical-stage neuroscience focus.
Vistagen Therapeutics reported preliminary positive data from the open-label extension of its PALISADE-3 Phase 3 study of fasedienol nasal spray for social anxiety disorder. In 341 adults using 3.2 µg as needed for up to 12 months, treatment was well-tolerated, with a 2.6% discontinuation rate due to adverse events and no events attributed to fasedienol. Most treatment-emergent side effects were mild or moderate, mainly headache and upper respiratory infection, and no serious adverse events were related to the drug.
Clinician-rated Liebowitz Social Anxiety Scale scores improved by 25.4 points at Month 4 from a very severe baseline of 99.2, with over half of patients achieving at least a 20‑point gain. Patient-reported Social Phobia Inventory scores improved by 12.4 points at Month 4 from a severe baseline of 48.7, with 55% reaching at least a 10‑point improvement. These benefits were seen even in participants who had not responded in the randomized portion of PALISADE-3, which previously failed its primary endpoint in a public speaking challenge.
Vistagen highlights ongoing late-stage development: PALISADE-4, another Phase 3 public speaking challenge study, has completed last patient visits and is expected to deliver topline data in the second quarter of 2026, while an exploratory repeat‑dose Phase 2 study is expected to report topline results in the third quarter of 2026. The company believes successful PALISADE results, together with evidence of sustained, clinically meaningful improvement, could support a potential New Drug Application for fasedienol in social anxiety disorder.
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.
Vistagen Therapeutics reported that the FDA issued a “Study May Proceed” letter under its U.S. Investigational New Drug application for refisolone nasal spray. This clearance allows the company to advance refisolone’s Phase 2 clinical development in the U.S. for menopausal vasomotor symptoms, or hot flashes.
The update highlights prior exploratory Phase 2a data from Mexico, where refisolone showed rapid, statistically significant reductions in hot flash frequency and severity versus placebo and was well-tolerated, supporting further development of this non-hormonal, intranasal women’s health candidate.
Vistagen Therapeutics, Inc. approved retention awards in the form of stock option grants for all employees. Key executives, including the CEO, CLO, Chief Corporate Development Officer, COO, and CFO, each received options to purchase up to 75,000 shares of common stock.
The options were granted on April 7, 2026 under the Amended and Restated 2019 Omnibus Equity Incentive Plan at an exercise price of $0.5358 per share. Twenty-five percent vests six months after the grant date, with additional 25% installments every six months until fully vested after two years.
Vistagen Therapeutics, Inc. notified Nasdaq that it is not currently in compliance with Nasdaq Listing Rule 5605(c)(2) because its Audit Committee has only two members instead of the required three independent directors. This followed the resignation of director Mary Rotunno effective April 1, 2026. The listing of Vistagen’s common stock on The Nasdaq Capital Market is not affected by this non-compliance. Under Nasdaq Listing Rule 5605(c)(4)(B), the company has a cure period lasting until its next annual stockholder meeting or one year from the resignation date, with a shorter 180-day period if that meeting occurs within 180 days. The Board plans to regain compliance within the allowed timeframe.
Vistagen Therapeutics, Inc. reported a board change. On March 17, 2026, Mary Rotunno resigned from the company’s Board of Directors, with her resignation effective April 1, 2026. The filing does not describe any related changes to executive management or company operations.
Vistagen Therapeutics, Inc. furnished an investor presentation outlining its intranasal “pherine” pipeline, which targets nose‑to‑brain neurocircuitry for neurological and psychiatric disorders. The company highlights five clinical‑stage product candidates and emphasizes rapid onset, non‑systemic delivery and favorable safety in completed studies.
The presentation focuses on fasedienol for acute treatment of social anxiety disorder, including a Phase 3 PALISADE‑2 trial that met its primary endpoint on the Subjective Units of Distress Scale and an ongoing Phase 3 PALISADE‑4 study. It also describes positive Phase 2a data for itruvone in major depressive disorder and refisolone for menopausal hot flashes and premenstrual dysphoric disorder, along with early‑stage programs PH15 for psychomotor/cognitive impairment due to mental fatigue and PH284 for cancer cachexia.
Vistagen Therapeutics, Inc. reported that its board approved a reduction of its workforce by approximately 20%. The company states this step is intended to support disciplined cash management while focusing resources on ongoing clinical studies in its PALISADE Program for fasedienol in social anxiety disorder.
Vistagen expects topline results from its PALISADE-4 Phase 3 trial in the first half of 2026 and currently anticipates its cash runway extending into 2027. Affected employees may receive cash severance and temporary healthcare coverage if they are eligible, elect coverage, and sign a separation agreement with a general release of claims. The company expects associated costs to be immaterial but notes additional costs could arise.
Vistagen Therapeutics, Inc. reported that on February 13, 2026, board member Paul Edick resigned from its Board of Directors. The company did not provide additional details about the circumstances of his resignation.
The company stated that it is actively seeking new candidates to fill the resulting vacancy on the Board, indicating its intention to maintain a full board composition.
Vistagen Therapeutics reported fiscal 2026 third quarter results showing higher spending as it advances late-stage neuroscience programs. Revenue was modest at $0.3 million, while research and development expense rose to $14.2 million from $11.3 million, and general and administrative expense increased to $5.6 million from $4.0 million. Net loss widened to $18.9 million compared with $14.1 million a year earlier.
Cash, cash equivalents, and marketable securities totaled $61.8 million as of December 31, 2025. The PALISADE-4 Phase 3 trial of fasedienol in social anxiety disorder is ongoing, with topline results from the randomized portion expected in the first half of 2026 after refinements informed by PALISADE-3, which did not meet its primary endpoint. The company is also preparing a U.S. IND filing in the first half of 2026 for refisolone (PH80) in menopausal hot flashes and has implemented cash preservation initiatives to support completing PALISADE-4 and advancing its pherine pipeline.
Vistagen Therapeutics, Inc. received a Nasdaq notice that its common stock no longer meets the Nasdaq Capital Market’s minimum $1.00 bid price requirement, after trading below that level for 30 consecutive business days. The notice does not immediately affect the stock’s Nasdaq listing.
To regain compliance, Vistagen’s closing bid price must reach at least $1.00 per share for 10 consecutive business days during the 180-day period from February 3, 2026 to August 3, 2026. If the company still does not comply, Nasdaq may grant a second 180-day period if other listing standards are met, after which the stock could be delisted if compliance is not restored.
Vistagen Therapeutics, Inc. filed a current report to let investors know it has begun using a new corporate presentation as of January 9, 2026. The presentation is attached as Exhibit 99.1 and is described as the company’s corporate presentation dated January 2026.
The company notes that the information in this presentation is being furnished, not filed, which means it is not subject to certain liability provisions of the Securities Exchange Act and is not automatically incorporated into other SEC filings unless specifically referenced. No financial results, major transactions, or other operational changes are described in this report; the focus is on making the updated investor presentation publicly available.
Vistagen Therapeutics, Inc. reported that it released its financial results for its fiscal year 2026 second quarter, which ended on September 30, 2025. The company disclosed that these results were announced in a press release dated November 13, 2025, which is included with this report as Exhibit 99.1.
The report explains that the press release and related information are being furnished, not filed, meaning they are not automatically subject to certain Exchange Act liabilities or incorporated into other securities filings unless specifically referenced.
Vistagen Therapeutics (VTGN) furnished a Regulation FD update announcing that the last patient has completed the randomized, double-blind, placebo-controlled public speaking challenge portion of its PALISADE-3 Phase 3 clinical trial evaluating fasedienol for the acute treatment of social anxiety disorder.
The company attached a press release as Exhibit 99.1. The information was furnished under Item 7.01 and is not deemed filed under Section 18 of the Exchange Act.
Vistagen Therapeutics (VTGN) appointed Paul R. Edick to its Board of Directors effective October 27, 2025. He will serve until the next annual meeting or until a successor is elected, and he joins the Board’s Audit and Compensation Committees.
Under the Director Compensation Plan, Mr. Edick received stock options for 35,200 shares at an exercise price of $3.90 per share, equal to the closing price on his appointment date. The options have a 10-year term and vest in equal annual installments over three years starting on the one-year anniversary of the effective date. The company also entered into an Indemnification Agreement with Mr. Edick, providing indemnification to the fullest extent permitted under Nevada law and advancement of certain expenses.
Vistagen Therapeutics announced that Chief Financial Officer and principal financial and accounting officer Cynthia L. Anderson has decided to resign effective October 15, 2025. The company states her decision is not due to any disagreement on operations, policies, or practices and plans to enter a consulting agreement so she can provide advisory support during the transition to her successor.
The company also reported results from its 2025 Annual Meeting of Stockholders held on September 9, 2025. Stockholders elected six directors to the board, approved on a non-binding advisory basis the compensation of named executive officers with 11,482,372 votes for, 299,397 against, and 1,019,952 abstentions, and ratified the appointment of KPMG LLP as independent registered public accounting firm with 21,166,179 votes for, 346,550 against, and 55,123 abstentions for the fiscal year ending March 31, 2026.
Vistagen Therapeutics (Nasdaq: VTGN) filed an 8-K disclosing a C-suite change under Item 5.02.
- Elissa Cote, age 50, was appointed Chief Corporate Development Officer effective June 23 2025.
- Cote’s background includes senior strategy and BD roles at Mallinckrodt, Sucampo and MedImmune, plus advisory work since 2022.
- The Company executed a customary Indemnification Agreement with Cote, attached as Exhibit 10.1, requiring full indemnity and expense advancement to the maximum extent allowed by Nevada law.
- No related-party transactions or special arrangements were reported.
- Press release announcing the hire is filed as Exhibit 99.1.
No financial metrics were updated; the report is limited to leadership and governance matters.