Vistagen Therapeutics, Inc.

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.

Vistagen Therapeutics, Inc. announced it received a "Study May Proceed" letter from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for refisolone nasal spray. This non-hormonal, non-systemic product candidate is in Phase 2 development for treating moderate to severe vasomotor symptoms (hot flashes) due to menopause. The FDA's decision allows Vistagen to advance refisolone into further Phase 2 clinical development in the U.S., building on successful exploratory Phase 2a studies conducted in Mexico.

Vistagen Therapeutics' Compensation Committee approved retention stock option awards for all company employees, including five key executives. Each executive, including the CEO and CFO, received options to purchase up to 75,000 shares at an exercise price of $0.5358 per share. These options will vest over two years, with 25% vesting after six months and subsequent 25% installments every six months thereafter, aiming to incentivize and retain talent.

Vistagen Therapeutics' Compensation Committee approved retention stock option awards for all company employees, including five key executives. Each of the named executives, such as President and CEO Shawn K. Singh and CFO Nick B. Tressler, received options to purchase up to 75,000 shares of common stock. These options, issued at an exercise price of $0.5358 per share, will vest over a two-year period, with 25% vesting every six months, aiming to incentivize and retain key talent.