Axsome Therapeutics Highlights Data Across Its Leading Neuroscience Pipeline at Psych Congress 2025
Axsome Therapeutics (NASDAQ: AXSM) will present six posters showcasing clinical and real-world data across its neuroscience portfolio at Psych Congress 2025 in San Diego. The presentations cover multiple therapeutic areas including major depressive disorder, Alzheimer's disease agitation, narcolepsy, and obstructive sleep apnea.
Key presentations include data on Auvelity® for major depressive disorder, results from the ACCORD-2 Phase 3 trial of AXS-05 in Alzheimer's disease agitation, and findings from the SYMPHONY Phase 3 trial of AXS-12 in narcolepsy. Additional presentations will cover the ENCORE trial in narcolepsy, the CRESCENDO Survey analysis, and real-world data on solriamfetol in obstructive sleep apnea from the SURWEY study.
Axsome Therapeutics (NASDAQ: AXSM) presenterà sei poster che mostrano dati clinici e real-world dall'intero portafoglio neuroscienze al Psych Congress 2025 di San Diego. Le presentazioni riguarderanno diverse aree terapeutiche tra cui disturbo depressivo maggiore, agitazione nella malattia di Alzheimer, narcolessia e apnea ostruttiva del sonno. Le presentazioni chiave includono dati su Auvelity® per il disturbo depressivo maggiore, i risultati dello studio ACCORD-2 di fase 3 di AXS-05 nell'agitazione della malattia di Alzheimer, e le scoperte dello studio SYMPHONY di fase 3 di AXS-12 nella narcolessia. Ulteriori interventi presenteranno lo studio ENCORE nella narcolessia, l'analisi del CRESCENDO Survey e dati real-world su solriamfetol nell'apnea ostruttiva del sonno dallo studio SURWEY.
Axsome Therapeutics (NASDAQ: AXSM) presentará seis posters que muestran datos clínicos y del mundo real de su portafolio de neurociencias en en San Diego. Las presentaciones abarcan varias áreas terapéuticas incluyendo trastorno depresivo mayor, agitación en la enfermedad de Alzheimer, narcolpesia y apnea obstructiva del sueño. Las presentaciones clave incluyen datos sobre Auvelity® para el trastorno depresivo mayor, resultados del ensayo de fase 3 ACCORD-2 de AXS-05 en la agitación de la enfermedad de Alzheimer, y hallazgos del ensayo de fase 3 SYMPHONY de AXS-12 en la narcolpsia. Otras presentaciones cubrirán el ensayo ENCORE en narcolapsia, el análisis de la encuesta CRESCENDO y datos del mundo real sobre solriamfetol en la apnea obstructiva del sueño del estudio SURWEY.
Axsome Therapeutics (NASDAQ: AXSM)는 샌디에이고에서 열리는 Psych Congress 2025에서 신경과학 포트폴리오의 임상 및 실제 데이터를 보여주는 포스터 6편을 발표합니다. 발표는 주요 우울장애, 알츠하이머병 동요, 나르콜렙시, 수면무호흡증 등 여러 치료 영역을 다룹니다. 주요 발표에는 Auvelity®가이드 우울장애에 대한 데이터, 알츠하이머병 동요에서 AXS-05의 ACCORD-2 3상 시험 결과, 나르콜렙시에서 AXS-12의 SYMPHONY 3상 시험 발견이 포함됩니다. 추가 발표로는 나르콜렙시의 ENCORE 시험, CRESCENDO 설문 분석, SURWEY 연구의 수면무호흡증에 대한 솔리람페톨의 실제 데이터가 다뤄질 예정입니다.
Axsome Therapeutics (NASDAQ: AXSM) présentera six posters montrant des données cliniques et du monde réel issues de son portefeuille en neurosciences lors du Psych Congress 2025 à San Diego. Les présentations couvrent plusieurs domaines thérapeutiques, dont le trouble dépressif majeur, l’agitation liée à la maladie d’Alzheimer, la narcolepsie et l’apnée du sommeil obstructive. Les présentations clés incluent des données sur Auvelity® pour le trouble dépressif majeur, les résultats de l’essai de phase 3 ACCORD-2 de AXS-05 dans l’agitation de la maladie d’Alzheimer et les résultats de l’essai de phase 3 SYMPHONY de AXS-12 dans la narcolepsie. D’autres présentations couvriront l’essai ENCORE dans la narcolepsie, l’analyse de l’enquête CRESCENDO et les données du monde réel sur le solriamfetol dans l’apnée du sommeil obstructive issus de l’étude SURWEY.
Axsome Therapeutics (NASDAQ: AXSM) wird sechs Poster vorstellen, die klinische und reale Welt-Daten aus dem gesamten Neuroscience-Portfolio beim Psych Congress 2025 in San Diego zeigen. Die Präsentationen decken mehrere therapeutische Bereiche ab, darunter Major Depressive Disorder, Agitation bei Alzheimer, Narcolepsie und obstruktive Schlafapnoe. Zu den Schlüsselpräsentationen gehören Daten zu Auvelity® für Major Depression, Ergebnisse der ACCORD-2-Phase-3-Studie von AXS-05 bei Alzheimer-Agitation und Erkenntnisse aus der SYMPHONY-Phase-3-Studie von AXS-12 in der Narcolepsie. Weitere Präsentationen befassen sich mit der ENCORE-Studie in Narcolepsie, der CRESCENDO-Umfrage-Analyse und realen Daten zu Solriamfetol bei obstruktiver Schlafapnoe aus der SURWEY-Studie.
ستعرض Axsome Therapeutics (ناسداك: AXSM) ستة لافتات تُظهر بيانات سريرية وبيانات من العالم الواقعي عبر محفظة العلوم العصبية لديها في Psych Congress 2025 في سان دييغو. تغطي العروض مجالات علاجية متعددة بما في ذلك اضطراب اكتئاب شديد، التهيج المصاحب لمرض الزهايمر، النَرْكُلِيبِس، وانقطاع النفس النومي الانسدادي. تتضمن العروض الرئيسية بيانات عن Auvelity® لاضطراب الاكتئاب الشديد، نتائج تجربة ACCORD-2 من المرحلة الثالثة لـ AXS-05 في تهيج مرض الزهايمر، واكتشافات من تجربة SYMPHONY من المرحلة الثالثة لـ AXS-12 في النَرْكُلِيبِس. ستغطي عروض إضافية تجربة ENCORE في النَّرْكولِيبِس، تحليل استقصاء CRESCENDO، وبيانات واقعية عن solriamfetol في انقطاع النفس النومي الانسدادي من دراسة SURWEY.
Axsome Therapeutics（AXSM，纳斯达克股票代码）将于圣地亚哥的 Psych Congress 2025 上展示六份海报，展示其神经科学组合的临床和真实世界数据。演示涵盖多个治疗领域，包括重度抑郁障碍、阿尔茨海默病相关激动、发作性嗜睡症和阻塞性睡眠呼吸暂停。主要演示包括用于重度抑郁障碍的 Auvelity® 数据、AXS-05 在阿尔茨海默病激动中的 ACCORD-2 III 期试验结果，以及 AXS-12 在narcolepsie 的 SYMPHONY III 期试验发现。其他演示将覆盖 narcolepsie 的 ENCORE 试验、CRESCENDO 调查分析，以及来自 SURWEY 研究的关于阻塞性睡眠呼吸暂停的 solriamfetol 的真实世界数据。
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Six poster presentations showcase clinical and real-world data in major depressive disorder, Alzheimer’s disease agitation, narcolepsy, and obstructive sleep apnea
NEW YORK, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced six presentations across its broad portfolio of innovative neuroscience products and product candidates at Psych Congress 2025, being held September 17 - 21, 2025, in San Diego, California.
Details of the presentations are as follows:
Major Depressive Disorder
- Title: Initiating Auvelity® (dextromethorphan 45 mg-bupropion 105 mg) in Patients with Major Depressive Disorder: Expert Panel Consensus Recommendations
Presentation Date and Time: Friday, September 19, 1:30 - 3:00 p.m. and 6:00 - 7:15 p.m.; Saturday, September 20, 1:30 - 3:00 p.m. PT
Lead Author: Anita H. Clayton, MD, Professor and Chair of Psychiatry and Neurobehavioral Sciences at the University of Virginia School of Medicine
Poster Number: 184
Alzheimer’s Disease Agitation
- Title: Efficacy and Safety of AXS-05 in Alzheimer's Disease Agitation: Results From ACCORD-2, a Phase 3 Randomized Withdrawal Double-Blind Placebo-Controlled Study
Presentation Date and Time: Friday, September 19, 1:30 - 3:00 p.m. and 6:00 - 7:15 p.m.; Saturday, September 20, 1:30 - 3:00 p.m. PT
Lead Author: Jeffrey Cummings, MD, ScD, Vice Chair of Research, UNLV Department of Brain Health
Poster Number: 47
Narcolepsy
- Title: Impact of AXS-12 on Symptom Severity and Functional Impairment in Narcolepsy: Results from the Phase 3 SYMPHONY Trial
Presentation Date and Time: Friday, September 19, 1:30 - 3:00 p.m. and 6:00 - 7:15 p.m.; Saturday, September 20, 1:30 - 3:00 p.m. PT
Lead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY
Poster Number: 118
- Title: ENCORE: Topline Results of a Phase 3 Open-Label Extension and Randomized-Withdrawal Trial of AXS-12 in Narcolepsy
Presentation Date and Time: Friday, September 19, 1:30 - 3:00 p.m. and 6:00 - 7:15 p.m.; Saturday, September 20, 1:30 - 3:00 p.m. PT
Lead Author: Richard Bogan, MD, FCCP, FAASM, Associate Clinical Professor at the University of South Carolina School of Medicine in Columbia, SC
Poster Number: 42
- Title: Residual Symptom Burden in Patients with Narcolepsy Satisfied with Treatment: Subgroup Analysis from the CRESCENDO Survey
Presentation Date and Time: Friday, September 19, 1:30 - 3:00 p.m. and 6:00 - 7:15 p.m.; Saturday, September 20, 1:30 - 3:00 p.m. PT
Lead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY
Poster Number: 110
Obstructive Sleep Apnea (OSA)
- Title: Effects of Solriamfetol on Neuropsychological Outcomes in Patients with Obstructive Sleep Apnea in the Real-World SURWEY Study
Presentation Date and Time: Friday, September 19, 1:30 - 3:00 p.m. and 6:00 - 7:15 p.m.; Saturday, September 20, 1:30 - 3:00 p.m. PT
Lead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology, Johannes Gutenberg-University, Mainz, Germany
Poster Number: 116
About Axsome Therapeutics
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.
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 commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® 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; 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 Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; 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 commercialization of SUNOSI, AUVELITY, and SYMBRAVO 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 circumstances.
Investors:
Ashley Dong
Director, Investor Relations
(929) 687-1614
adong@axsome.com
Media:
Darren Opland
Senior Director, Corporate Communications
(929) 837-1065
dopland@axsome.com
FAQ
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