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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 (VTGN) presented new research on Social Anxiety Disorder (SAD) at the 2025 ADAA Conference, building on findings from the 2024 NEI Congress. The research reveals that SAD affects nearly 31 million U.S. adults, with increasing prevalence especially among young adults aged 18-22.
Key findings show that while SAD prevalence has increased, diagnosis rates remain stagnant and treatment rates have decreased. Over 20% of adults with SAD reported suicidal ideation, and 75% experienced mild to severe depression. In the 18-22 age group, 48.1% reported suicidal ideation, showing higher depression rates and worse mental health outcomes than those without SAD.
Data from Vistagen's fasedienol PALISADE Phase 3 studies revealed that 30% of participants had SAD onset at age 10 or younger, with an average 27-year delay before first treatment. The research emphasizes the urgent need for improved diagnosis, treatment options, and social support mechanisms.
Vistagen (Nasdaq: VTGN), a clinical-stage biopharmaceutical company focused on neuroscience and nose-to-brain neurocircuitry, will present at the Anxiety and Depression Association of America (ADAA) Conference in Las Vegas from April 3-5, 2025.
The company will showcase two poster presentations focusing on social anxiety disorder (SAD):
- On April 4, 2025: Research on age of onset of SAD in fasedienol (PH94B) nasal spray trials (Poster F40)
- On April 5, 2025: A cross-sectional study examining SAD among young adults aged 18-22 using US National Health and Wellness Survey data (Poster S109)
Both posters will be made available on Vistagen's website on April 7, 2025. The presentations highlight the company's work with pherines, a new class of intranasal product candidates.
Vistagen (Nasdaq: VTGN), a clinical-stage biopharmaceutical company focused on neuroscience and nose-to-brain neurocircuitry, has announced its participation in the upcoming Stifel 2025 Virtual CNS Forum. The company's President and CEO, Shawn Singh, will engage in a fireside chat presentation on March 18, 2025, at 12 p.m. Eastern Time.
The company specializes in developing and commercializing a novel class of intranasal product candidates called pherines. Interested parties can access the live webcast through the 'Events' page in the 'Investors' section of Vistagen's website, with a replay available after the event.
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.
