Vistagen Therapeutics Inc Stock Price, News & Analysis

VistaGen Therapeutics (NASDAQ: VTGN) has achieved a significant milestone in its PALISADE-1 Phase 3 clinical trial of PH94B for social anxiety disorder (SAD), with topline results expected mid-2022. The FDA has confirmed that no Human Abuse Potential (HAP) study is needed, indicating a favorable safety profile. Financially, VistaGen reported a net loss of approximately $48.7 million for FY 2022, up from $42.3 million the previous year. R&D expenses surged from $11.9 million to $35.4 million, reflecting commitment to clinical trials. Cash reserves stand at around $68.1 million.

VistaGen Therapeutics (Nasdaq: VTGN) has announced the completion of the PALISADE-1 Phase 3 clinical trial for PH94B, aimed at treating adults with social anxiety disorder (SAD). This U.S. multi-center, randomized study evaluates the efficacy and safety of PH94B during stressful public speaking scenarios. Anticipated topline results are set for mid-2022. Notably, PH94B has received FDA Fast Track designation, enhancing its development prospects. The company is also conducting a second trial, PALISADE-2, with results expected later in 2022.

VistaGen Therapeutics (NASDAQ: VTGN) has scheduled a conference call for June 23, 2022, at 2:00 PM PT to discuss its fiscal year 2022 financial results, ending March 31, 2022. The call will also cover recent achievements and future milestones. The company is focused on advancing therapeutics for anxiety and depression, particularly its lead candidate, PH94B, a nasal spray currently in Phase 3 trials in the U.S. Results are expected in 2022. If successful, PH94B could become the first FDA-approved rapid treatment for social anxiety.

VistaGen Therapeutics, Inc. (Nasdaq: VTGN) announced the acceptance of an abstract for its Phase 2A clinical trial studying PH94B, a rapid-onset nasal spray for anxiety disorders, at the ASCP Annual Meeting from May 31 to June 3, 2022. The trial focuses on adjustment disorder with anxiety (AjDA), aiming to evaluate efficacy and safety. PH94B is noted for its unique mechanism, intended to offer rapid relief from anxiety symptoms. CEO Shawn Singh emphasized the increasing mental health challenges and the demand for innovative treatments amidst this urgent need.

VistaGen Therapeutics (Nasdaq: VTGN) announced participation in two upcoming investor conferences in June: the William Blair 42nd Annual Growth Stock Conference on June 7 at 2:00 PM CT in Chicago, and the Jefferies Global Healthcare Conference on June 9 at 10:00 AM ET in New York. CEO Shawn Singh will engage in discussions aimed at transforming treatment for anxiety and depression. The company’s lead candidate, PH94B, is positioned to be a leading fast-acting treatment for social anxiety disorder, currently undergoing Phase 3 trials in the U.S.

VistaGen Therapeutics (Nasdaq: VTGN) announced that the FDA confirmed there is no signal of abuse potential for its investigational treatment PH94B, designed for acute treatment of adults with social anxiety disorder (SAD). Based on completed clinical and nonclinical data, the FDA stated additional studies to assess abuse potential are unnecessary, and a human abuse potential study is not needed at this time. VistaGen is advancing PH94B through its Phase 3 PALISADE program. With over 25 million affected in the U.S., effective treatment options are critical for those suffering from SAD.

VistaGen Therapeutics (Nasdaq: VTGN) has appointed Reid Adler as its new Chief Legal Officer. Adler brings over three decades of legal experience and has previously served as outside counsel for the company. He will oversee legal affairs and provide strategic guidance to VistaGen’s Executive Team and Board. CEO Shawn Singh expressed confidence in Adler's leadership, emphasizing the company's commitment to transforming mental health treatment. VistaGen focuses on advancing therapeutics for anxiety and depression, aiming to launch faster-acting treatments with fewer side effects.

VistaGen Therapeutics (Nasdaq: VTGN) announced the presentation of preclinical data at significant scientific meetings, emphasizing the unique mechanism of action (MOA) of their candidate PH94B, aimed at treating social anxiety disorder (SAD). Notably, PH94B's anxiolytic properties do not require systemic uptake, reducing side effect risks. Researchers will showcase findings on April 30 and during the ASCP meeting in June 2022. VistaGen is currently conducting Phase 3 trials for PH94B, seeking to address the rising mental health crisis effectively.

VistaGen Therapeutics (NASDAQ: VTGN) and AffaMed Therapeutics have completed regulatory preparations for the PALISADE Global Phase 3 clinical trial of PH94B. This trial will assess the efficacy, safety, and tolerability of PH94B, a nasal spray, for treating social anxiety disorder (SAD) in adults. Expected to initiate in the second half of 2022, the trial aims to support commercialization in China and other markets outside the U.S. The trial design is based on previous PALISADE studies, with initial results anticipated by mid-2024.