Axsome Therapeutics Presents Data from Multiple Programs Spanning Its Innovative Neuroscience Portfolio at Psych Congress 2024
Axsome Therapeutics (NASDAQ: AXSM) announced seven presentations at Psych Congress 2024 showcasing data from its neuroscience portfolio. The presentations cover multiple therapeutic areas including Major Depressive Disorder, featuring studies on AXS-05 (Auvelity®), Alzheimer's Disease Agitation with Phase 2/3 development program results, and research on Solriamfetol for excessive daytime sleepiness in patients with narcolepsy and OSA. The presentations include data on improving anhedonia, interest-activity symptoms, and cognitive effects in various patient populations.
Axsome Therapeutics (NASDAQ: AXSM) ha annunciato sette presentazioni al Psych Congress 2024 per mostrare i dati del suo portafoglio nel settore neuroscientifico. Le presentazioni coprono diverse aree terapeutiche, tra cui il Disturbo Depressivo Maggiore, con studi su AXS-05 (Auvelity®), Agitazione nella Malattia di Alzheimer con risultati del programma di sviluppo di Fase 2/3, e ricerche su Solriamfetol per eccessiva sonnolenza diurna nei pazienti con narcolessia e OSA. Le presentazioni includono dati sul miglioramento dell'anedonia, sintomi di interesse-attività e effetti cognitivi in diverse popolazioni di pazienti.
Axsome Therapeutics (NASDAQ: AXSM) anunció siete presentaciones en el Psych Congress 2024 que muestran datos de su cartera de neurociencia. Las presentaciones abarcan múltiples áreas terapéuticas, incluido el Trastorno Depresivo Mayor, con estudios sobre AXS-05 (Auvelity®), Agitación en la Enfermedad de Alzheimer con resultados de programas de desarrollo de Fase 2/3, y una investigación sobre Solriamfetol para la somnolencia diurna excesiva en pacientes con narcolepsia y OSA. Las presentaciones incluyen datos sobre la mejora de la anhedonia, síntomas de interés-actividad y efectos cognitivos en diversas poblaciones de pacientes.
Axsome Therapeutics (NASDAQ: AXSM)은 Psych Congress 2024에서 자사의 정신신경 과학 포트폴리오 데이터를 보여주는 7개의 발표를 발표했습니다. 이 발표는 주요 우울 장애를 포함한 여러 치료 분야를 다루며, AXS-05 (Auvelity®)에 대한 연구, 알츠하이머병의 초조증에 대한 2/3상 개발 프로그램 결과, 그리고 기면증 및 OSA 환자에서의 과도한 주간 졸음에 대한 솔리람페톨 연구를 포함합니다. 발표 내용에는 다양한 환자 집단에서의 무쾌감, 흥미-활동 증상 및 인지 영향 개선에 관한 데이터가 포함됩니다.
Axsome Therapeutics (NASDAQ: AXSM) a annoncé sept présentations lors du Psych Congress 2024, mettant en avant des données de son portefeuille en neurosciences. Les présentations couvrent plusieurs domaines thérapeutiques, y compris le Trouble Dépressif Majeur, avec des études sur AXS-05 (Auvelity®), Agitation dans la Maladie d'Alzheimer avec des résultats de programme de développement de phase 2/3, et des recherches sur Solriamfetol pour la somnolence diurne excessive chez les patients atteints de narcolepsie et d'OSA. Les présentations incluent des données sur l'amélioration de l'anhedonie, des symptômes d'intérêt-activité et des effets cognitifs dans diverses populations de patients.
Axsome Therapeutics (NASDAQ: AXSM) hat sieben Präsentationen auf dem Psych Congress 2024 angekündigt, die Daten aus seinem Neurowissenschaftsportfolio präsentieren. Die Präsentationen decken mehrere therapeutische Bereiche ab, darunter Major Depression, mit Studien zu AXS-05 (Auvelity®), Agitation bei Alzheimer-Krankheit mit Ergebnissen aus dem Phase 2/3-Entwicklungsprogramm sowie Forschungen zu Solriamfetol für übermäßige Tagesmüdigkeit bei Patienten mit Narkolepsie und OSA. Die Präsentationen enthalten Daten zur Verbesserung von Anhedonie, Interessen-Aktivitätssymptomen und kognitiven Effekten in verschiedenen Patientengruppen.
- Multiple clinical data presentations across different therapeutic areas showing portfolio diversity
- Continued development and research of AXS-05 (Auvelity®) for major depressive disorder
- Advancement of Phase 2/3 program for Alzheimer's Disease Agitation
- None.
NEW YORK, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced seven presentations from across its broad portfolio of innovative neuroscience products and product candidates at Psych Congress 2024, being held Oct. 29 - Nov. 2, 2024, in Boston, Massachusetts.
Details for the presentations are as follows:
Major Depressive Disorder
Title: AXS-05 (Auvelity®) in Major Depressive Disorder: Pooled Data from Two Six-Week Controlled Trials (GEMINI and ASCEND)
Presentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ET
Lead Author: Craig Chepke, MD, SUNY Upstate Medical University
Poster Number: 171
Title: Effects of AXS-05 (Auvelity®) in Improving Anhedonia and Interest-Activity Symptoms of MDD and the Associated Improvements in Functional Impairment
Presentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ET
Lead Author: Roger McIntyre, MD, Professor of Psychiatry and Pharmacology at the University of Toronto
Poster Number: 172
Title: Real-World Treatment Experiences and Expectations by Symptom Severity in Patients with Major Depressive Disorder
Presentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ET
Lead Author: Roger McIntyre, MD, Professor of Psychiatry and Pharmacology at the University of Toronto
Poster Number: 198
Alzheimer’s Disease Agitation
Title: Clinical Profile of AXS-05 in Treating Alzheimer’s Disease-Related Agitation: Results from The Phase 2/3 Development Program
Presentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ET
Lead Author: Jeffrey Cummings, MD, ScD, Vice Chair of Research, UNLV Department of Brain Health
Poster Number: 45
OSA and Narcolepsy
Title: Solriamfetol for Excessive Daytime Sleepiness in Patients with Narcolepsy and OSA Reporting Anxiety and Depression in the Real-World SURWEY Study
Presentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ET
Lead Author: Ulf Kallweit, MD, Assistant Professor of Neurology at the University Witten/Herdecke, Germany
Poster Number: 20
Cognition
Title: Effects of Solriamfetol on Cognition in Obstructive Sleep Apnea with Excessive Daytime Sleepiness and Impaired Cognition in the SHARP Clinical Trial
Presentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ET
Lead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, department of neurology, Johannes Gutenberg-University, Mainz, Germany
Poster Number: 92
Title: Effects of Solriamfetol on Cognition in Patients with Excessive Daytime Sleepiness Associated with Narcolepsy in the Real-World SURWEY Study
Presentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ET
Lead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, department of neurology, Johannes Gutenberg-University, Mainz, Germany
Poster Number: 164
About Axsome Therapeutics
Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at www.axsome.com.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the continued commercial success of the Company’s Sunosi® and Auvelity® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; whether issues identified by FDA in the complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to the Company’s special protocol assessment for the MOMENTUM clinical trial; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the continued commercialization of Sunosi and Auvelity and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.
Investors:
Mark Jacobson
Chief Operating Officer
(212) 332-3243
mjacobson@axsome.com
Media:
Darren Opland
Director, Corporate Communications
(929) 837-1065
dopland@axsome.com
FAQ
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