Vistagen Therapeutics, Inc.

Vistagen Therapeutics, Inc. announced its 2026 Annual Meeting of Stockholders will be held virtually on September 10, 2026. Stockholders will vote on the election of four director nominees, a non-binding advisory resolution on executive compensation, and the ratification of KPMG LLP as the independent registered public accounting firm. The record date for voting eligibility is July 22, 2026, and proxy materials are available online.

Vistagen Therapeutics, Inc. announced the appointment of Douglas J. Williamson, MD, to its Board of Directors. Dr. Williamson brings significant experience in neuroscience drug development, having guided therapies from early development through regulatory approval and commercialization at companies like QurAlis, Acadia Pharmaceuticals, H. Lundbeck, and Eli Lilly. His expertise is expected to be invaluable as Vistagen advances its neuroscience pipeline and explores corporate growth opportunities.

Vistagen Therapeutics announced that its PALISADE-4 Phase 3 trial of fasedienol for acute social anxiety disorder did not achieve its primary endpoint. The trial, which used the Subjective Units of Distress Scale (SUDS) as the primary measure, showed no statistically significant improvement over placebo in the overall population. However, a post-hoc analysis of patients with very severe social anxiety disorder revealed a nominally statistically significant improvement. The company reported favorable safety and tolerability data and plans to engage with the FDA to discuss a new registrational pathway, potentially involving a single future Phase 3 trial with the Liebowitz Social Anxiety Scale (LSAS) as the primary endpoint.

Vistagen Therapeutics, Inc. announced that two members of its Board of Directors, Ms. Margaret FitzPatrick and Dr. Joanne Curley, have decided not to seek re-election at the company's 2026 Annual Meeting of Stockholders. Both directors will continue their service until their current terms conclude at the upcoming annual meeting.

Vistagen Therapeutics reported mixed results for its lead product candidate, fasedienol, in its Phase 3 PALISADE-3 trial for social anxiety disorder, which did not meet its primary endpoint. This follows a previous miss in PALISADE-1 but a success in PALISADE-2. The company expects topline results for PALISADE-4 in Q2 2026 and the Repeat Dose Study in Q3 2026, while preliminary open-label extension data showed favorable safety and exploratory efficacy. Additionally, Vistagen received a "Study May Proceed" letter from the FDA for U.S. Phase 2 development of refisolone for menopausal hot flashes and continues to advance other pipeline candidates like itruvone, PH15, and PH284.

Vistagen Therapeutics announced significant progress in its clinical pipeline, including the completion of the randomized portion of its PALISADE-4 Phase 3 trial for fasedienol, with topline results anticipated in June 2026. The company also completed a Phase 2 repeat dose study for fasedienol and received FDA clearance to proceed with refisolone's clinical development for hot flashes. Financially, Vistagen reported a net loss of $69.7 million for fiscal year 2026, an increase from the prior year, with cash reserves expected to last into 2027.

Vistagen Therapeutics announced its fasedienol nasal spray clinical program for social anxiety disorder achieved minimum patient exposures under ICH E1 safety recommendations. As of May 31, 2026, over 1,500 subjects received at least one dose, with over 300 having 6-month and over 100 having 12-month exposures. The company expects topline results from its PALISADE-4 Phase 3 trial in Q2 2026 and Phase 2 Repeat Dose study in Q3 2026, which, if successful, could support a U.S. NDA submission. Fasedienol has Fast Track designation and a differentiated mechanism of action.

Vistagen Therapeutics, Inc. announced the appointment of Angel S. Angelov, M.D., MBA, as its new Chief Medical Officer, effective May 18, 2026. Dr. Angelov brings over two decades of leadership experience in clinical development and medical affairs from companies like Theranica, Karuna Therapeutics, and Neurocrine Biosciences. His compensation package includes an annual base salary of $425,000, a $50,000 signing bonus, eligibility for an annual cash bonus, and an inducement grant of stock options to purchase 150,000 shares.

Vistagen Therapeutics announced preliminary positive data from the ongoing open-label extension (OLE) portion of its PALISADE-3 Phase 3 study of fasedienol for the acute treatment of social anxiety disorder. Fasedienol nasal spray was well-tolerated for up to 12 months of as-needed use, with no new drug-related safety findings. Exploratory efficacy data over four months showed clinically relevant improvements in social anxiety on both clinician-administered (LSAS) and patient-reported (SPIN) scales.

Vistagen Therapeutics announced the completion of the last patient visit in the randomized, double-blind, placebo-controlled portion of its PALISADE-4 Phase 3 clinical trial for fasedienol nasal spray, targeting acute social anxiety disorder. Topline results for this portion of the study are anticipated in the second quarter of 2026. The company also refined the statistical analysis plan for PALISADE-4, incorporating pre-dosing distress levels, a change the FDA had no comments on. This trial, if successful, along with previous positive results, could support a New Drug Application submission.