Latest news with #Vistagen
Business Wire
2 days ago
- Business
- Business Wire
Vistagen on Track to Deliver Topline Data From Fasedienol PALISADE-3 Phase 3 Trial for Acute Treatment of Social Anxiety Disorder in the Fourth Quarter of This Year
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today provides an update on the timeline for the ongoing clinical trials in its U.S. registration-directed PALISADE Phase 3 Program evaluating fasedienol for acute treatment of social anxiety disorder (SAD). The Company's PALISADE-3 Phase 3 clinical trial remains on track for expected topline data in the fourth quarter of this year. Topline results for its PALISADE-4 Phase 3 clinical trial are expected in the first half of 2026. 'We are very encouraged by the progress of our PALISADE-3 trial, which remains on track for a topline readout in the fourth quarter of this year, and our PALISADE-4 trial, for which we expect topline results in the first half of 2026,' said Shawn Singh, President and Chief Executive Officer of Vistagen. 'Patient and physician enthusiasm for our PALISADE trials continues to be strong, and we remain focused on meticulous patient recruitment. With social anxiety affecting millions and rising, we are energized by fasedienol's potential to meet the clear and growing unmet need and bring meaningful relief to patients, all while delivering long-term value to shareholders.' Vistagen reported positive results from its PALISADE-2 Phase 3 trial of fasedienol for acute treatment of SAD in 2023. The Company's ongoing PALISADE-3 and PALISADE-4 Phase 3 trials involve the same public speaking challenge study design as its successful PALISADE-2 Phase 3 trial, as well as certain protocol and operational enhancements related to site training, surveillance and subject selection. These strategic enhancements, which have extended certain timelines in the PALISADE Phase 3 program, were designed with the objective of replicating the success of PALISADE-2. Vistagen believes either PALISADE-3 or PALISADE-4, if successful, together with the positive results from PALISADE-2, may establish substantial evidence of the effectiveness of fasedienol in support of a potential fasedienol New Drug Application (NDA) submission to the U.S. FDA for the acute treatment of SAD. About Social Anxiety Disorder Social anxiety disorder (SAD) is a highly prevalent, serious, and sometimes life-threatening psychiatric mental health disorder affecting over 30 million adults in the U.S. With onset typically early in life, usually during adolescence, SAD persists for many years thereafter, with a reported mean duration of about 20 years. While often a long-term disorder, SAD can manifest acutely when triggered by anxiety-provoking social and performance situations during which individuals with SAD experience extreme anxiety, distress, fear, and impairment due to their feelings of embarrassment, judgment, humiliation, negative evaluation, and scrutiny. The disorder can significantly disrupt family and social life, diminish self-esteem, and hinder work performance. Anxiety associated with SAD often results in avoidance of everyday interactions and opportunities in academic, social, and vocational settings and an increased risk of serious and life-threatening co-morbid depression, substance abuse, suicidal ideation, and suicide. About Fasedienol Nasal Spray for the Acute Treatment of Social Anxiety Disorder Fasedienol is Vistagen's potential first-in-class, investigational neurocircuitry-focused pherine nasal spray designed to have rapid onset with a novel mechanism of action (MOA) that is differentiated from all currently approved anxiety medications. Fasedienol is designed to regulate the olfactory-amygdala neural circuits of fear and anxiety and attenuate the tone of the sympathetic autonomic nervous system without systemic absorption, potentiation of GABA-A receptors, or binding to neurons in the brain. The U.S. FDA has granted Fast Track designation for the development of fasedienol for the acute treatment of SAD. About Vistagen's U.S. Registration-directed PALISADE Phase 3 Program for Acute Treatment of Social Anxiety Disorder The ongoing clinical trials in Vistagen's U.S. registration-directed PALISADE Phase 3 Program for fasedienol for the acute treatment of SAD include its PALISADE-3 and PALISADE-4 Phase 3 trials and a small Phase 2 repeat dose study, which is being conducted at the FDA's request to further elucidate fasedienol's dose response and MOA. PALISADE-3 and PALISADE-4 are multi-center, randomized, double-blind, placebo-controlled Phase 3 trials designed similarly to PALISADE-2 to evaluate the efficacy, safety, and tolerability of the acute administration of fasedienol to relieve anxiety symptoms in subjects with SAD induced by a public speaking challenge conducted in a clinical setting. PALISADE-3 remains on track for topline data in the fourth quarter of 2025. Topline results for PALISADE-4 and the repeat dose study are expected in the first half of 2026. Vistagen believes either PALISADE-3 or PALISADE-4, if successful, together with the positive results from PALISADE-2, may establish substantial evidence of the effectiveness of fasedienol in support of a potential fasedienol New Drug Application (NDA) submission to the U.S. FDA for the acute treatment of SAD. About Vistagen Headquartered in South San Francisco, CA, Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company leveraging a deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of clinical-stage product candidates from a new class of intranasal therapies called pherines. Pherines specifically and selectively bind as agonists to peripheral receptors on human nasal chemosensory neurons, and are designed to rapidly activate olfactory bulb-to-brain neurocircuits believed to regulate brain areas involved in behavior and autonomic nervous system activity. They are designed to achieve therapeutic benefits without requiring absorption into the blood or uptake into the brain, giving them the potential to be a safer alternative to other pharmacological options. Vistagen's neuroscience pipeline also includes an oral prodrug with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent indications, including social anxiety disorder, major depressive disorder, and multiple women's health conditions, including vasomotor symptoms (hot flashes) associated with menopause. Connect at Forward-looking Statements This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of words such as 'may,' 'could,' 'expect,' 'project,' 'outlook,' 'strategy,' 'intend,' 'plan,' 'seek,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'potential,' 'strive,' 'goal,' 'continue,' 'likely,' 'will,' 'would' and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by Vistagen and its management, are inherently uncertain. As with all pharmaceutical products, there are substantial risks and uncertainties in the process of development and commercialization, and actual results or developments may differ materially from those projected or implied in these forward-looking statements. There can be no guarantee that any of Vistagen's product candidates, including fasedienol, will successfully complete ongoing or future clinical trials within estimated timelines or at all, receive regulatory approval or be commercially successful. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to conducting and/or completing ongoing clinical trials, including that are a part of Vistagen's PALISADE Phase 3 program, as currently expected or at all; submission of a NDA to the U.S. FDA for any of Vistagen's product candidate, including fasedienol; the ability of any clinical trial information submitted by Vistagen to the U.S. FDA to successfully support a NDA; Vistagen's dependence on third-party collaborators for the development, regulatory approval, and/or commercialization of its product candidates and other aspects of its business, which are outside of Vistagen's full control; risks associated with current and potential future healthcare reforms; the scope and enforceability of Vistagen's patents, including patents related to Vistagen's pherine product candidates and AV-101; fluctuating costs of materials and other resources and services required to conduct Vistagen's ongoing and/or planned clinical and non-clinical trials; market conditions; the impact of general economic, industry or political conditions in the United States or internationally; and other technical and unexpected hurdles in the development, manufacture and commercialization of Vistagen's product candidates. These risks are more fully discussed in the section entitled 'Risk Factors' in Vistagen's Annual Report on Form 10-K for the fiscal year ended March 31, 2024, and Quarterly Report on Form 10-Q for the period ended December 31, 2024, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the U.S. Securities and Exchange Commission (SEC). Vistagen's SEC filings are available on the SEC's website at You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release and should not be relied upon as representing Vistagen's views as of any subsequent date. Vistagen explicitly disclaims any obligation to update any forward-looking statements other than as may be required by law. If Vistagen does update one or more forward-looking statements, no inference should be made that Vistagen will make additional updates with respect to those or other forward-looking statements.
Yahoo
23-05-2025
- Health
- Yahoo
Vistagen to Present at the 2025 American Society of Clinical Psychopharmacology Conference
Posters Highlight New Insights into Social Anxiety Disorder and the Novel Mechanism of Action of Itruvone to Treat Major Depressive Disorder SOUTH SAN FRANCISCO, Calif., May 23, 2025--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced it will present at the American Society of Clinical Psychopharmacology (ASCP) Conference in Scottsdale, Arizona from May 27-30, 2025. The Company's poster presentations will explore the age of onset of social anxiety disorder (SAD) from participants in fasedienol clinical trials, and the impact of itruvone – the company's investigational pherine for the treatment of major depressive disorder – on the electrogram of nasal chemosensory receptors (EGNR) and the olfactory bulb electrogram (EBG), both biomarkers of itruvone's effect on nasal chemosensory neurons and olfactory bulb physiologic activation. Poster Presentations: Date: Wednesday, May 28, 2025, 11:15 a.m. – 1:00 p.m. Eastern TimeTitle: Age of Onset of Social Anxiety Disorder (SAD) in Trials of Fasedienol (PH94B) Nasal SprayAuthors: Ester Salmán, MPH; Ross A. Baker, PhD; Stephen D. Coffey, BA; Rita Hanover, PhD; Michael R. Liebowitz, MD; and Louis Monti, MD, PhDPoster Number: W5 Date: Thursday, May 29, 2025, 11:30 a.m. - 1:00 p.m. Eastern TimeTitle: Antidepressant Itruvone Nasal Spray Depolarizes Nasal Chemosensory Receptors Followed by Increased Gamma Power Spectral Density of the Olfactory Bulb in Healthy SubjectsAuthors: Louis Monti, MD, PhD; Danajane Katz, BS; Ester Salmán, MPH; Weiping Zhang, PhD; Ross A. Baker, PhD; and Rita Hanover, PhDPoster Number: T73 These posters will be available on the Publications page of Vistagen's website on Monday, June 2, 2025. About Vistagen Headquartered in South San Francisco, CA, Vistagen (Nasdaq: VTGN) is a clinical-stage biopharmaceutical company leveraging a deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of clinical-stage product candidates from a new class of intranasal therapies called pherines. Pherines specifically and selectively bind as agonists to peripheral receptors in human nasal chemosensory neurons, rapidly activating olfactory bulb-to-brain neurocircuits which regulate brain areas involved in behavior and autonomic nervous system activity. They are designed to achieve therapeutic benefits without requiring absorption into the blood or uptake into the brain, giving them the potential to be a safer alternative to other pharmacological options. Vistagen's neuroscience pipeline also includes an oral prodrug with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent indications, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at View source version on Contacts Investor Inquiries: Mark A. McPartlandmarkmcp@ Media Inquiries: Michelle P. Wellingtonmwellington@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
23-05-2025
- Health
- Business Wire
Vistagen to Present at the 2025 American Society of Clinical Psychopharmacology Conference
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Vistagen (Nasdaq: VTGN), a clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced it will present at the American Society of Clinical Psychopharmacology (ASCP) Conference in Scottsdale, Arizona from May 27-30, 2025. The Company's poster presentations will explore the age of onset of social anxiety disorder (SAD) from participants in fasedienol clinical trials, and the impact of itruvone – the company's investigational pherine for the treatment of major depressive disorder – on the electrogram of nasal chemosensory receptors (EGNR) and the olfactory bulb electrogram (EBG), both biomarkers of itruvone's effect on nasal chemosensory neurons and olfactory bulb physiologic activation. Poster Presentations: Title: Age of Onset of Social Anxiety Disorder (SAD) in Trials of Fasedienol (PH94B) Nasal Spray Authors: Ester Salmán, MPH; Ross A. Baker, PhD; Stephen D. Coffey, BA; Rita Hanover, PhD; Michael R. Liebowitz, MD; and Louis Monti, MD, PhD Poster Number: W5 Date: Thursday, May 29, 2025, 11:30 a.m. - 1:00 p.m. Eastern Time Title: Antidepressant Itruvone Nasal Spray Depolarizes Nasal Chemosensory Receptors Followed by Increased Gamma Power Spectral Density of the Olfactory Bulb in Healthy Subjects Authors: Louis Monti, MD, PhD; Danajane Katz, BS; Ester Salmán, MPH; Weiping Zhang, PhD; Ross A. Baker, PhD; and Rita Hanover, PhD Poster Number: T73 These posters will be available on the Publications page of Vistagen's website on Monday, June 2, 2025. About Vistagen Headquartered in South San Francisco, CA, Vistagen (Nasdaq: VTGN) is a clinical-stage biopharmaceutical company leveraging a deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of clinical-stage product candidates from a new class of intranasal therapies called pherines. Pherines specifically and selectively bind as agonists to peripheral receptors in human nasal chemosensory neurons, rapidly activating olfactory bulb-to-brain neurocircuits which regulate brain areas involved in behavior and autonomic nervous system activity. They are designed to achieve therapeutic benefits without requiring absorption into the blood or uptake into the brain, giving them the potential to be a safer alternative to other pharmacological options. Vistagen's neuroscience pipeline also includes an oral prodrug with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent indications, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at
Yahoo
04-03-2025
- Business
- Yahoo
Vistagen to Participate in Stifel 2025 Virtual CNS Forum
SOUTH SAN FRANCISCO, Calif., March 04, 2025--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced that management will participate in Stifel's 2025 Virtual CNS Forum. Vistagen's President and Chief Executive Officer, Shawn Singh, will participate in a fireside chat presentation on Tuesday, March 18, 2025, at 12 p.m. Eastern Time. A live webcast will be accessible through the "Events" page in the "Investors" section of the Company's website at A replay of the webcast will be archived and available following the event. About Vistagen Headquartered in South San Francisco, CA, Vistagen (Nasdaq: VTGN) is a clinical-stage biopharmaceutical company leveraging a deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of clinical-stage product candidates from a new class of intranasal therapies called pherines. Pherines specifically and selectively bind to peripheral receptors in human nasal chemosensory neurons, which activate olfactory bulb-to-brain neurocircuits without requiring systemic absorption or uptake into the brain to achieve desired therapeutic benefits and differentiated safety. Vistagen's neuroscience pipeline also includes an oral prodrug with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent indications, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at View source version on Contacts Investor Inquiries: Mark A. McPartlandmarkmcp@ Media Inquiries: Michelle P. Wellingtonmwellington@ Sign in to access your portfolio
Yahoo
06-02-2025
- Business
- Yahoo
Vistagen to Report Fiscal Year 2025 Third Quarter Results and Host Corporate Update Conference Call on February 13, 2025
SOUTH SAN FRANCISCO, Calif., February 06, 2025--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced it will host a conference call and webcast on Thursday, February 13, 2025 at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) to report results for its fiscal year 2025 third quarter ended December 31, 2024, and provide a corporate update. The conference call is being webcast live and a link can be found under "Events" in the Investors section of the Company's website. Participants may register for the live call link HERE to receive the dial-in numbers and unique PIN to access the call. It is recommended that you join 15 minutes prior to the start of the event. A webcast replay of the call will be available on Vistagen's website within 24 hours after the end of the live conference call and will be accessible for at least 90 days. About Vistagen Headquartered in South San Francisco, CA, Vistagen (Nasdaq: VTGN) is a clinical-stage biopharmaceutical company leveraging a deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of clinical-stage product candidates from a new class of intranasal therapies called pherines. Pherines specifically and selectively bind to peripheral receptors in human nasal chemosensory neurons, which activate olfactory bulb-to-brain neurocircuits without requiring systemic absorption or uptake into the brain to achieve desired therapeutic benefits and differentiated safety. Vistagen's neuroscience pipeline also includes an oral prodrug with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent disorders, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at View source version on Contacts Investors Inquiries: Mark A. McPartlandmarkmcp@ Media Inquiries: Michelle Wellingtonmwellington@ Sign in to access your portfolio
