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 (Nasdaq: VTGN), a clinical-stage biopharmaceutical company focused on neuroscience and pherine development, has announced its participation in the 45th Annual TD Cowen Healthcare Conference. The company's President and CEO, Shawn Singh, will deliver a corporate overview on Monday, March 3, 2025, at 2:30 p.m. Eastern Time.
The presentation will be accessible via webcast through the 'Events' page in the 'Investors' section of Vistagen's website. Investors and interested parties can access the replay of the webcast, which will be archived on the company's website after the event.
Vistagen (VTGN) reported its fiscal Q3 2025 financial results and provided updates on its clinical pipeline. The company's PALISADE Phase 3 Program for fasedienol in social anxiety disorder is advancing with PALISADE-3, PALISADE-4, and Repeat Dose trials, with top-line results expected later in 2025.
The company reported positive results from a Phase 2A trial of PH284 in cancer cachexia, marking their fifth pherine product candidate with positive efficacy signals. Financial results show R&D expenses increased to $11.3 million from $4.5 million year-over-year, while G&A expenses rose slightly to $4.0 million from $3.8 million. Net loss widened to $14.1 million compared to $6.4 million in the same period last year. The company maintained a strong cash position of $88.6 million as of December 31, 2024.
Vistagen (Nasdaq: VTGN), a clinical-stage biopharmaceutical company focused on neuroscience and pherine-based intranasal treatments, has scheduled its fiscal year 2025 third quarter financial results conference call and webcast for February 13, 2025 at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time). The company will present results for the quarter ended December 31, 2024, along with a corporate update.
The event will be accessible via webcast through the company's website under the 'Events' section of the Investors area. Participants can register online to receive dial-in information and a unique PIN for the live call, with recommended joining 15 minutes before the start time. A replay will be available on Vistagen's website within 24 hours and remain accessible for at least 90 days.
Vistagen (VTGN) has been granted a U.S. patent for AV-101, its oral non-opioid product candidate for treating neuropathic pain. The patent extends until at least 2034 and is part of Vistagen's global patent portfolio for AV-101's manufacturing methods and therapeutic uses involving the NMDA receptor.
Preclinical studies published in The Journal of Pain showed AV-101's antinociceptive effects similar to gabapentin but with a better side effect profile. Additional research comparing AV-101 to pregabalin demonstrated significant dose response and similar efficacy in chronic neuropathic pain models.
Clinical data from Phase 1 studies published in the Scandinavian Journal of Pain indicated that oral AV-101 was well-tolerated, showing no meaningful difference in adverse events between AV-101 and placebo. The company is now seeking strategic collaborations to advance AV-101's clinical development and commercialization for pain and dyskinesias.
Vistagen (VTGN) announced positive results from an exploratory Phase 2A study of PH284, a pherine nasal spray designed to treat cancer cachexia. The double-blind, placebo-controlled study involved 40 female patients with terminal cancer-induced cachexia. PH284 demonstrated significant improvements in subjective feelings of hunger (SFH), with patients reporting a 71% improvement versus baseline prior to dinner on Day 7, compared to less than 1% in the placebo group.
The treatment protocol involved administering PH284 nasal spray (0.4 µg/50 µL) four times daily before meals. The study showed cumulative positive effects on hunger scores throughout the treatment period. Safety results were favorable, with no serious adverse events reported and an adverse event profile similar to placebo. PH284 becomes the fifth pherine product candidate in Vistagen's neuroscience pipeline to show positive efficacy signals.
Vistagen (VTGN) has initiated a repeat dose study for fasedienol, its investigational nasal spray for treating Social Anxiety Disorder (SAD). The exploratory Phase 2 trial will evaluate the efficacy, safety, and tolerability of repeat doses in adults with SAD during public speaking challenges.
The multi-center, randomized, double-blind, placebo-controlled study includes three arms: fasedienol followed by fasedienol (6.4 micrograms total), fasedienol followed by placebo (3.2 micrograms total), and placebo followed by placebo. The second dose will be administered ten minutes after the initial dose. The study design mirrors the ongoing PALISADE Phase 3 studies, including an open-label extension.
Vistagen (Nasdaq: VTGN), a late clinical-stage neuroscience company, announced its participation in the Stifel 2024 Healthcare Conference in New York City on November 18-19, 2024. CEO Shawn Singh will lead a fireside chat on November 18 at 3:35 p.m. Eastern Time. The presentation will be available via webcast on the company's website through the 'Events' page in the 'Investors' section. Interested investors can arrange one-on-one meetings through their Stifel representatives.
Vistagen (VTGN) reported financial results for Q2 FY2025 ended September 30, 2024. The company initiated PALISADE-4 Phase 3 trial for fasedienol in social anxiety disorder treatment, with both PALISADE-3 and PALISADE-4 trials progressing towards top-line results in 2025. Net loss increased to $13.0 million compared to $6.6 million in the same quarter last year. R&D expenses rose to $10.2 million from $3.9 million, while G&A expenses increased to $4.2 million from $3.2 million. The company maintained a strong cash position of $97.6 million as of September 30, 2024.
Vistagen (Nasdaq: VTGN) announced its participation in the 2024 Neuroscience Education Institute Congress in Colorado Springs, presenting three key posters on November 8, 2024. The presentations will showcase new prevalence data for social anxiety disorder (SAD) related to fasedienol, their lead intranasal pherine product in Phase 3 development. Additional presentations will cover itruvone, their Phase 2 candidate for major depressive disorder, and PH80, a hormone-free treatment in Phase 2 development for menopausal hot flashes.
The posters will address SAD prevalence trends, itruvone's effects on nasal receptors and olfactory bulb electrograms, and pain symptom analysis for PH80 in PMDD treatment. All presentations are scheduled for 3:35 p.m. Mountain Time, with posters becoming available on Vistagen's website on November 11, 2024.
Vistagen (NASDAQ: VTGN), a late clinical-stage neuroscience company, will host a conference call and webcast on November 7, 2024, at 2:00 p.m. Pacific Time to report its fiscal year 2025 second quarter results ended September 30, 2024, and provide a corporate update. The call will be accessible via toll-free and international dial-in numbers, with a webcast option available. A replay will be accessible after the call using provided replay access numbers.
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