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Vistagen to Present at the 2024 Neuroscience Education Institute Congress

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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) ha annunciato la sua partecipazione al Congresso dell'Istituto di Educazione Neuroscientifica 2024 a Colorado Springs, presentando tre poster chiave l'8 novembre 2024. Le presentazioni mostreranno nuovi dati sulla prevalenza del disturbo d'ansia sociale (SAD) relativi al fasedienolo, il loro principale prodotto intranasale in fase di sviluppo di Fase 3. Ulteriori presentazioni riguarderanno itruvone, il loro candidato di Fase 2 per il disturbo depressivo maggiore, e PH80, un trattamento senza ormoni in fase di sviluppo di Fase 2 per le vampate di calore menopausali.

I poster affronteranno le tendenze di prevalenza del SAD, gli effetti dell'itruvone sui recettori nasali e sugli elettrogrammi del bulbo olfattivo, e l'analisi dei sintomi del dolore per il PH80 nel trattamento della PMDD. Tutte le presentazioni sono programmate per le 15:35, ora montana, con i poster che saranno disponibili sul sito web di Vistagen l'11 novembre 2024.

Vistagen (Nasdaq: VTGN) anunció su participación en el Congreso del Instituto de Educación en Neurociencias 2024 en Colorado Springs, presentando tres carteles clave el 8 de noviembre de 2024. Las presentaciones mostrarán nuevos datos de prevalencia sobre el trastorno de ansiedad social (SAD) relacionados con el fasedienol, su principal producto intranasal de feromonas en desarrollo de Fase 3. Presentaciones adicionales cubrirán itruvone, su candidato de Fase 2 para el trastorno depresivo mayor, y PH80, un tratamiento sin hormonas en desarrollo de Fase 2 para los sofocos menopáusicos.

Los carteles abordarán las tendencias de prevalencia del SAD, los efectos de itruvone sobre los receptores nasales y los electrogramas del bulbo olfativo, y el análisis de síntomas de dolor para PH80 en el tratamiento de PMDD. Todas las presentaciones están programadas para las 3:35 p.m., hora de montaña, y los carteles estarán disponibles en el sitio web de Vistagen el 11 de noviembre de 2024.

비스테겐 (Nasdaq: VTGN)은 2024년 콜로라도 스프링스에서 열리는 신경과학 교육 연구소 회의에 참석하여 2024년 11월 8일에 세 가지 주요 포스터를 발표한다고 발표했습니다. 이 발표에서는 3상 개발 중인 주요 비강 페로몬 제품인 사회 불안장애(SAD)와 관련된 새로운 유병률 데이터를 소개할 것입니다. 추가 발표는 주요 우울 장애를 위한 2상 후보인 이트루본(itruvone)과 폐경기 열감 치료를 위한 2상 개발 중인 호르몬 프리 치료제인 PH80을 다룰 것입니다.

포스터는 SAD 유병률 추세, nasal 수용체 및 후각 신경로 전기그래프에 대한 이트루본의 효과, 그리고 PMDD 치료를 위한 PH80의 통증 증상 분석을 다룰 것입니다. 모든 발표는 산악 표준시로 오후 3시 35분에 예정되어 있으며, 포스터는 2024년 11월 11일에 비스테겐 웹사이트에서 확인할 수 있습니다.

Vistagen (Nasdaq: VTGN) a annoncé sa participation au Congrès de l'Institut d'Éducation en Neurosciences 2024 à Colorado Springs, où elle présentera trois affiches clés le 8 novembre 2024. Les présentations mettront en avant de nouvelles données sur la prévalence du trouble d'anxiété sociale (SAD) en lien avec le fasedienol, leur principal produit intranasal de phéromones en développement de phase 3. Des présentations supplémentaires porteront sur l'itruvone, leur candidat de phase 2 pour le trouble dépressif majeur, et le PH80, un traitement sans hormones en développement de phase 2 pour les bouffées de chaleur ménopausiques.

Les affiches aborderont les tendances de prévalence du SAD, les effets de l'itruvone sur les récepteurs nasaux et les électrogrammes du bulbe olfactif, ainsi que l'analyse des symptômes de douleur pour le PH80 dans le traitement du PMDD. Toutes les présentations sont programmées pour 15h35, heure de la montagne, avec des affiches disponibles sur le site Web de Vistagen à partir du 11 novembre 2024.

Vistagen (Nasdaq: VTGN) gab seine Teilnahme am 2024 Neuroscience Education Institute Kongress in Colorado Springs bekannt, wo am 8. November 2024 drei wichtige Poster präsentiert werden. Die Präsentationen werden neue Prävalenzdaten für soziale Angststörung (SAD) in Bezug auf Fasedienol, ihr führendes intranasales Pherin-Produkt in der Phase-3-Entwicklung, vorstellen. Weitere Präsentationen befassen sich mit Ituvone, ihrem Phase-2-Kandidaten für die schwere depressive Störung, und PH80, einer hormonfreien Behandlung in der Phase-2-Entwicklung gegen Hitzewallungen in der Menopause.

Die Poster werden Trends zur Prävalenz von SAD, die Wirkungen von Ituvone auf die nasalen Rezeptoren und die Elektroenzephalogramme des olfaktorischen Bulbus sowie die Schmerzsymptomanalyse für PH80 bei der Behandlung von PMDD thematisieren. Alle Präsentationen sind für 15:35 Uhr Mountain Time angesetzt, die Poster werden ab dem 11. November 2024 auf der Website von Vistagen verfügbar sein.

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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Vistagen (Nasdaq: VTGN), a late clinical-stage company dedicated to pioneering neuroscience based on nose-to-brain neurocircuitry, today announced that it will present posters highlighting new prevalence data for social anxiety disorder (SAD), an indication for which fasedienol, its lead intranasal pherine product candidate, is in U.S. registration-directed Phase 3 development for the acute treatment of the disorder, and two additional non-systemic intranasal pherine product candidates in its neuroscience pipeline, itruvone in Phase 2 development for major depressive disorder and hormone-free PH80 in Phase 2 development for the management of vasomotor symptoms (hot flashes) due to menopause, at the 2024 Neuroscience Education Institute (NEI) Congress in Colorado Springs, Colorado from November 7 to 10, 2024.

Poster Presentation
Date: Friday, November 8, 2024, 3:35 p.m. Mountain Time
Title: Prevalence Trends and Demographic Profiles of Social Anxiety Disorder: A Cross-sectional Study Using U.S. National Health and Wellness Survey
Authors: Ross A. Baker, PhD; Josh Prince; Soohyun Hwang, PhD, MPH; Nikoletta Sternbach
Poster Number: 95

Poster Presentation
Date: Friday, November 8, 2024, 3:35 p.m. Mountain Time
Title: Itruvone Nasal Spray Depolarizes Electrogram of Nasal Receptors and Increases Gamma Bandwidth of the Olfactory Bulb Electrogram in Healthy Subjects
Authors: Louis Monti, MD, PhD; Danajane Katz, BS; Ester Salmán, MPH; Weiping Zhang, PhD; Ross A. Baker, PhD; Rita Hanover, PhD
Poster Number: 66

Poster Presentation
Date: Friday, November 8, 2024, 3:35 p.m. Mountain Time
Title: Pain Symptom Cluster Analysis from the Daily Symptom Report in a Phase 2a Study of PH80 for the Treatment of Premenstrual Dysphoric Disorder (PMDD)
Authors: Louis Monti, MD, PhD; Ross A. Baker, PhD; Rita Hanover, PhD
Poster Number: 94

The posters will be available on the Publications page of Vistagen’s website on Monday, November 11, 2024.

About Fasedienol Nasal Spray for Acute Treatment of Social Anxiety Disorder
Fasedienol is a potential first-in-class, investigational neuroactive 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 direct activity on neurons in the brain. Vistagen’s U.S. registration-directed PALISADE Phase 3 program for fasedienol is focused on the acute treatment of SAD. Fasedienol has not demonstrated any signals of abuse potential or suggested any potential for psychological and physical dependence in any clinical trial conducted to date. There is no U.S. FDA-approved acute treatment for SAD. The U.S. FDA has granted Fast Track designation for the investigation of fasedienol for the acute treatment of SAD.

About Itruvone Nasal Spray for Major Depressive Disorder
Itruvone is an investigational pherine nasal spray designed to have rapid onset, with a novel proposed neurocircuitry-focused mechanism of action (MOA) that is fundamentally differentiated from the MOA of all currently approved treatments for depression disorders. Itruvone is administered intranasally at microgram-level doses and is designed to regulate olfactory-to-amygdala neural circuitry believed to increase the activity of the limbic-hypothalamic sympathetic nervous system and increase the release of catecholamines to produce antidepressant effects, without systemic absorption or brain penetration and without many of the side effects and safety concerns potentially associated with currently approved antidepressants. The FDA has granted Fast Track designation for the development of itruvone as a potential treatment for major depressive disorder.

About PH80 Nasal Spray for Vasomotor Symptoms (Hot Flashes) Due to Menopause
PH80 is a hormone-free investigational neuroactive pherine nasal spray with a novel neurocircuitry-focused mechanism of action (MOA) that is fundamentally differentiated from all currently approved treatment options for women’s health indications. PH80’s proposed MOA does not require systemic absorption or direct activity on neurons in the brain. Vistagen is developing PH80 as a potential new non-systemic, hormone-free treatment for the management of vasomotor symptoms (hot flashes) due to menopause.

About Vistagen
Headquartered in South San Francisco, CA, Vistagen (Nasdaq: VTGN) is a late clinical-stage company leveraging a deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of intranasal product candidates called pherines. Each pherine product candidate in Vistagen’s neuroscience pipeline is designed to rapidly activate olfactory system and brain neurocircuitry to achieve desired therapeutic benefits and differentiated safety without requiring systemic absorption or direct activity on neurons in the brain. Vistagen’s neuroscience pipeline also includes an oral prodrug, AV-101, 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 www.Vistagen.com.

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 (the Company) 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. Among other things, there can be no guarantee that fasedienol, itruvone, PH80, or any of the Company’s other product candidates will successfully complete ongoing or future clinical trials, receive regulatory approval or be commercially successful. These risks and others are more fully discussed in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2024, and in the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 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). The Company’s SEC filings are available on the SEC’s website at www.sec.gov. 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 the Company’s views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements other than as may be required by law. If the Company does update one or more forward-looking statements, no inference should be made that the Company will make additional updates with respect to those or other forward-looking statements.

Investors:

Mark McPartland

Vistagen Therapeutics

markmcp@vistagen.com

Media:

Caren Scannell

Vistagen Therapeutics

cscannell@vistagen.com

Source: Vistagen

FAQ

When will Vistagen (VTGN) present at the 2024 NEI Congress?

Vistagen will present three posters on Friday, November 8, 2024, at 3:35 p.m. Mountain Time during the 2024 NEI Congress in Colorado Springs.

What products will Vistagen (VTGN) discuss at the 2024 NEI Congress?

Vistagen will present data on three products: fasedienol for social anxiety disorder, itruvone for major depressive disorder, and PH80 for menopausal vasomotor symptoms.

Where can I find Vistagen's (VTGN) 2024 NEI Congress poster presentations?

The posters will be available on the Publications page of Vistagen's website starting Monday, November 11, 2024.

What is the development stage of Vistagen's (VTGN) fasedienol?

Fasedienol is in U.S. registration-directed Phase 3 development for the acute treatment of social anxiety disorder (SAD).

Vistagen Therapeutics, Inc.

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