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 (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.
Vistagen, The Goldie Hawn Foundation, and MindUP students will ring the Nasdaq Closing Bell on October 10, 2024, in honor of World Mental Health Day and The Goldie Hawn Foundation's 20th Anniversary. This event brings together Vistagen CEO Shawn Singh, Foundation Founder Goldie Hawn, and MindUP students to raise awareness about the roles of mindfulness and neuroscience in mental health.
Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company focusing on neuroscience-based therapies for psychiatric disorders. MindUP is a neuroscience-based preventative mental health program for youth. The joint ceremony highlights their shared commitment to advancing neuroscience-based innovation and improving mental well-being.
Goldie Hawn emphasized the importance of understanding brain function for mental fitness and resilience in children. Shawn Singh highlighted Vistagen's belief in a multifaceted approach to improving mental health through awareness, education, and improved patient care.
Vistagen (Nasdaq: VTGN) has initiated the PALISADE-4 Phase 3 trial of fasedienol, an investigational neuroactive pherine nasal spray for the acute treatment of social anxiety disorder (SAD). This marks a significant milestone in the company's registration-directed PALISADE Phase 3 program. Fasedienol is designed for non-systemic, rapid activation of nose-to-brain neural circuits to reduce fear and anxiety associated with SAD.
CEO Shawn Singh highlighted the potential of fasedienol to provide a transformative acute treatment option for over 30 million Americans suffering from SAD, which is associated with increased risk for depression, alcohol abuse, and suicide attempts. Notably, current FDA-approved pharmacological therapies do not include an acute treatment option for SAD.
Vistagen (Nasdaq: VTGN) reported financial results for Q1 FY2025 and provided a corporate update. Key highlights include:
1. PALISADE Phase 3 Program for fasedienol in Social Anxiety Disorder (SAD) is progressing on track.
2. R&D expenses increased to $7.6 million, up from $4.2 million in Q1 FY2024.
3. G&A expenses rose to $4.6 million, compared to $3.0 million in Q1 FY2024.
4. Net loss widened to $10.7 million, versus $6.9 million in Q1 FY2024.
5. Cash, cash equivalents, and marketable securities stood at $108.4 million as of June 30, 2024.
6. The company is also advancing itruvone for Major Depressive Disorder and PH80 for menopausal hot flashes.
Vistagen (NASDAQ: VTGN), a late clinical-stage neuroscience-focused biopharmaceutical company, has announced a conference call and webcast scheduled for August 13, 2024, at 2:00 p.m. Pacific Time. The purpose of this event is to report the company's fiscal year 2025 first quarter results for the period ended June 30, 2024, and provide a corporate update.
Investors and interested parties can access the call via a toll-free US number (1-877-407-9716) or an international dial-in (1-201-493-6779), using the Conference ID: 13748020. A webcast will also be available. Following the call, a telephone playback will be accessible using the replay access ID number 13748020.
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