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Vistagen Therapeutics Inc (VTGN) is a clinical-stage biopharmaceutical company pioneering neuroscience-focused treatments through innovative stem cell technology. This page provides investors and industry professionals with essential updates on the company’s progress, including press releases, clinical trial milestones, and strategic developments.
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Key updates include progress in stem cell-derived bioassay systems, FDA communications regarding therapeutic candidates, and insights into the company’s unique approach to in vitro testing. All content is verified for accuracy and relevance to support informed decision-making.
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Vistagen (Nasdaq: VTGN) announced promising findings for PH94B, a first-in-class investigational nasal spray for treating social anxiety disorder. At Psych Congress in New Orleans on September 18, 2022, data showed that PH94B significantly activated nasal chemosensory cells, reduced sympathetic tone, and induced self-reported calmness in healthy subjects. Unlike steroid hormones, PH94B led to notable decreases in heart rate and stress indicators. No severe adverse events were reported, supporting further study of its therapeutic potential in anxiety disorders.
Vistagen Therapeutics, Inc. (Nasdaq: VTGN) announced that CEO Shawn Singh will participate in two upcoming investor conferences in New York. The events are:
- Morgan Stanley 20th Annual Global Healthcare Conference: September 13 at 9:10 a.m. ET
- Baird 2022 Global Healthcare Conference: September 14 at 2:35 p.m. ET
Vistagen is focused on transforming treatments for anxiety and depression using innovative pherines, which are designed to have rapid effects with minimal side effects.
Vistagen Therapeutics (NASDAQ: VTGN) reports that independent biostatisticians recommend continuing the PALISADE-2 Phase 3 clinical trial for PH94B, an innovative treatment for Social Anxiety Disorder (SAD). The interim analysis of 140 completed subjects showed no need for changes. Vistagen plans to enroll a total of 208 subjects and expects topline results in the first half of 2023. PH94B aims to provide a rapid-acting, intranasal treatment without the side effects commonly associated with existing medications, supporting a new approach to treating anxiety disorders.
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.
