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. (symbol: VTGN) is a pioneering biotechnology firm committed to improving the lives of patients with central nervous system (CNS) disorders. The company leverages its advanced stem cell technology platform, which is based on the controlled differentiation of human pluripotent stem cells into mature, non-transformed human cells. This innovative platform enables the creation of novel bioassay systems for predictive toxicology, drug metabolism screening, drug discovery, drug rescue, and cell therapy, providing clinically relevant predictions of potential toxicity and metabolism issues of promising new drug candidates long before they are ever tested in humans.
At the clinical stage, Vistagen is actively involved in developing and commercializing a robust pipeline consisting of six product candidates. Five of these candidates are clinical-stage investigational agents known as pherines, which represent a new class of drugs. Notable products within their portfolio include:
- PH94B: A novel neuroactive nasal spray designed to treat social anxiety disorder.
- PH10: An odorless, fast-acting synthetic neurosteroid aimed at addressing major depressive disorder (MDD).
- AV-101: An oral antagonist of the glycine site of the N-methyl-D-aspartate receptor (NMDAR), which is being developed to treat MDD, suicidal ideation, neuropathic pain, levodopa-induced dyskinesia (LID), and epilepsy.
Vistagen's innovative approach and dedication to CNS disorders position it as a significant player in the biotechnology sector. The company is continually making strides in its research and clinical trials, striving to bring groundbreaking therapies to market. Investors and stakeholders can look forward to Vistagen's ongoing developments and potential future successes as it targets unmet medical needs with its cutting-edge technologies and therapeutic candidates.
VistaGen Therapeutics, Inc. (Nasdaq: VTGN) reported its Q1 fiscal 2023 results, pausing enrollment in PALISADE-2 and conducting an interim analysis following PALISADE-1's failure to meet primary efficacy endpoints for PH94B in treating social anxiety disorder (SAD). However, preliminary data from nearly 200 subjects indicate potential cumulative functional improvement with PH94B. R&D expenses rose to $15.3 million, while G&A expenses increased to $4.8 million, leading to a net loss of $19.8 million. The company has $52 million in cash, anticipating a reduction in external spending to extend its cash runway.
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.