Welcome to our dedicated page for Vistagen Therapeutics news (Ticker: VTGN), a resource for investors and traders seeking the latest updates and insights on Vistagen Therapeutics stock.
Vistagen Therapeutics, Inc. develops late clinical-stage biopharmaceutical programs based on nose-to-brain neurocircuitry and intranasal pherine product candidates. Company news centers on fasedienol nasal spray for the acute treatment of social anxiety disorder, including PALISADE Phase 3 study updates, and refisolone nasal spray for vasomotor symptoms due to menopause.
Recurring updates also cover FDA and IND communications, clinical data from psychiatric and neurological programs, fiscal results, cash-management actions, executive and board changes, and healthcare investor conference presentations. The company’s pipeline is described around investigational intranasal candidates for indications that include social anxiety disorder, major depressive disorder, and menopausal hot flashes.
VistaGen Therapeutics, Inc. (NASDAQ: VTGN) will host a conference call and webcast on August 11, 2022, at 2:00 p.m. PT to discuss financial results for its fiscal year 2023 first quarter ending June 30, 2022. The call will highlight the company's advancements in developing treatments for anxiety and depression through investigational pherine nasal sprays PH94B and PH10, which aim to be faster-acting with fewer side effects.
VistaGen Therapeutics (Nasdaq: VTGN) announced that its PH94B did not meet the primary endpoint in the PALISADE-1 Phase 3 clinical trial for treating social anxiety disorder (SAD). The trial measured changes using the Subjective Units of Distress Scale (SUDS) compared to a placebo. Despite failing to meet efficacy benchmarks, PH94B exhibited a favorable safety and tolerability profile consistent with previous trials, with no severe adverse events reported. The company remains committed to further developing PH94B in ongoing trials targeting various anxiety disorders.
VistaGen Therapeutics (Nasdaq: VTGN) announced that CEO Shawn Singh will participate in a panel on unmet needs in neuropsychiatry at the William Blair Biotech Focus Conference on July 13, 2022, at 9:00 a.m. ET. He will also engage in one-on-one investor meetings and a recorded fireside chat. VistaGen focuses on developing fast-acting treatments for anxiety and depression, with its lead candidate PH94B in Phase 3 trials. Topline results are expected in 2022, potentially leading to the first FDA-approved acute anxiety treatment for social anxiety disorder.
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.