Axsome Therapeutics Presents Data from Its Leading Neuroscience Pipeline at NEI Congress 2024
Axsome Therapeutics (NASDAQ: AXSM) announced eight presentations at NEI Congress 2024, showcasing data from its late-stage CNS portfolio. The presentations cover multiple therapeutic areas including Major Depressive Disorder (featuring AXS-05/Auvelity® data from clinical trials and real-world studies), Alzheimer's Disease Agitation (Phase 2/3 development program results), and OSA and Narcolepsy (focusing on Solriamfetol's effects on excessive daytime sleepiness and cognition). The presentations include pooled data from controlled trials and real-world studies, examining treatment outcomes, patient characteristics, and cognitive effects.
Axsome Therapeutics (NASDAQ: AXSM) ha annunciato otto presentazioni al Congresso NEI 2024, mostrando dati dal suo portafoglio CNS in fase avanzata. Le presentazioni coprono diverse aree terapeutiche, tra cui Disturbo Depressivo Maggiore (presentando dati di AXS-05/Auvelity® da studi clinici e ricerche nel mondo reale), Agitazione nella Malattia di Alzheimer (risultati del programma di sviluppo di Fase 2/3) e OSA e Narcolessia (concentrandosi sugli effetti di Solriamfetol sulla sonnolenza diurna e sulla cognizione). Le presentazioni includono dati aggregati da studi controllati e ricerche nel mondo reale, esaminando gli esiti del trattamento, le caratteristiche dei pazienti e gli effetti cognitivi.
Axsome Therapeutics (NASDAQ: AXSM) anunció ocho presentaciones en el Congreso NEI 2024, mostrando datos de su cartera CNS en etapas avanzadas. Las presentaciones abarcan múltiples áreas terapéuticas, incluyendo Trastorno Depresivo Mayor (con datos de AXS-05/Auvelity® de ensayos clínicos y estudios del mundo real), Agitación en la Enfermedad de Alzheimer (resultados del programa de desarrollo de Fase 2/3) y OSA y Narcolepsia (enfocándose en los efectos de Solriamfetol sobre la somnolencia diurna excesiva y la cognición). Las presentaciones incluyen datos agrupados de ensayos controlados y estudios del mundo real, examinando los resultados del tratamiento, las características de los pacientes y los efectos cognitivos.
Axsome Therapeutics (NASDAQ: AXSM)는 NEI Congress 2024에서 8개의 발표를 하며 말기 CNS 포트폴리오의 데이터를 보여주었습니다. 발표 내용은 주요 우울 장애(임상 시험 및 실제 연구에서 AXS-05/Auvelity® 데이터 포함), 알츠하이머병의 불안증(2/3상 개발 프로그램 결과) 및 OSA와 기면증(Solriamfetol의 낮 시간 졸림증 및 인지 능력에 대한 영향을 중심으로) 등 여러 치료 분야를 아우릅니다. 발표에는 통제된 시험과 실제 연구에서 수집된 데이터를 합산하여 치료 결과, 환자 특성 및 인지 효과를 조사합니다.
Axsome Therapeutics (NASDAQ: AXSM) a annoncé huit présentations au Congrès NEI 2024, mettant en avant des données de son portefeuille CNS en phase avancée. Les présentations couvrent plusieurs domaines thérapeutiques, notamment le Trouble Dépressif Majeur (avec des données sur AXS-05/Auvelity® issues d'essais cliniques et d'études du monde réel), l'Agitation dans la Maladie d'Alzheimer (résultats du programme de développement de Phase 2/3) et l'OSA et la Narcolepsie (en mettant l'accent sur les effets du Solriamfetol sur la somnolence diurne excessive et la cognition). Les présentations incluent des données regroupées d'essais contrôlés et d'études du monde réel, examinant les résultats du traitement, les caractéristiques des patients et les effets cognitifs.
Axsome Therapeutics (NASDAQ: AXSM) gab bekannt, dass es acht Präsentationen beim NEI Congress 2024 geben wird, in denen Daten aus seinem fortgeschrittenen CNS-Portfolio vorgestellt werden. Die Präsentationen umfassen mehrere therapeutische Bereiche, darunter Major Depressive Disorder (mit AXS-05/Auvelity® Daten aus klinischen Studien und Real-World-Studien), Agitation bei Alzheimer (Ergebnisse des Entwicklungsprogramms der Phase 2/3) und OSA und Narkolepsie (mit Fokus auf die Auswirkungen von Solriamfetol auf übermäßige Tagesmüdigkeit und Kognition). Die Präsentationen enthalten gesammelte Daten aus kontrollierten Studien und Real-World-Studien, die Behandlungsergebnisse, Patienteneigenschaften und kognitive Effekte untersuchen.
- Multiple data presentations across different CNS indications showing pipeline progress
- Real-world data validation for marketed products
- Expansion of clinical evidence for key products in multiple therapeutic areas
- None.
NEW YORK, Nov. 08, 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 eight presentations spanning its innovative portfolio of late-stage products and product candidates in psychiatry and neurology at NEI Congress 2024, being held Nov. 7 - Nov. 10, 2024, in Colorado Springs, Colorado.
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: Friday, Nov. 8, 3:35 – 4:30 p.m. ET
Lead Author: Craig Chepke, MD, SUNY Upstate Medical University
Poster Number: 101
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: Friday, Nov. 8, 3:35 – 4:30 p.m. ET
Lead Author: Roger McIntyre, MD, Professor of Psychiatry and Pharmacology at the University of Toronto
Poster Number: 27
Title: Real-World Treatment Experiences and Expectations by Symptom Severity in Patients with Major Depressive Disorder
Presentation Date and Time: Friday, Nov. 8, 3:35 – 4:30 p.m. ET
Lead Author: Roger McIntyre, MD, Professor of Psychiatry and Pharmacology at the University of Toronto
Poster Number: 87
Title: Real-World AXS-05 (Auvelity®) Patient Characteristics in Major Depressive Disorder
Presentation Date and Time: Friday, Nov. 8, 3:35 – 4:30 p.m. ET
Lead Author: Andrew Muzyk, MD, Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC
Poster Number: 116
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: Friday, Nov. 8, 3:35 – 4:30 p.m. ET
Lead Author: Jeffrey Cummings, MD, ScD, Vice Chair of Research, UNLV Department of Brain Health
Poster Number: 25
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: Friday, Nov. 8, 3:35 – 4:30 p.m. ET
Lead Author: Ulf Kallweit, MD, Assistant Professor of Neurology at the University Witten/Herdecke, Germany
Poster Number: 98
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: Friday, Nov. 8, 3:35 – 4:30 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: 103
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: Friday, Nov. 8, 3:35 – 4:30 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: 97
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
What clinical data is Axsome (AXSM) presenting at NEI Congress 2024?
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