Press Releases June 15, 2026 07:00 AM

Axsome Therapeutics Presents New Data Highlighting its Innovative Sleep Medicine Portfolio at SLEEP 2026

Axsome Therapeutics showcases new clinical data for sleep disorder treatments at SLEEP 2026 conference

By Jordan Park
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Axsome Therapeutics presented new clinical data on its sleep disorder medicines AXS-12 and solriamfetol at SLEEP 2026, highlighting positive cognitive, functional, and quality-of-life outcomes in narcolepsy and obstructive sleep apnea patients. These presentations reinforce Axsome's leadership in central nervous system disorder treatments and its innovative neuroscience portfolio.

Axsome Therapeutics Presents New Data Highlighting its Innovative Sleep Medicine Portfolio at SLEEP 2026
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Key Points

  • New data from Phase 3 trials of AXS-12 show promising cognitive and functional benefits in narcolepsy with cataplexy patients.
  • Solriamfetol demonstrated effectiveness for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea through multi-dimensional analyses.
  • The presented data underline Axsome's strong pipeline targeting CNS disorders affecting millions in the US, potentially expanding market reach in sleep medicine.
  • The presentations may increase investor confidence ahead of potential regulatory milestones or commercial expansion.

NEW YORK, June 15, 2026 (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 presentations of new data on AXS-12 and solriamfetol at SLEEP 2026, the 40th annual meeting of the Associated Professional Sleep Societies (APSS), being held June 14-17, 2026, in Baltimore, Maryland.

Details of the presentations are as follows:

  • Title: Cognitive and Functional Outcomes from the Phase 3 Open-Label Extension and Randomized-Withdrawal ENCORE Trial of AXS-12 in Narcolepsy with Cataplexy
    Presentation Date and Time: Monday, June 15, 10:00 - 11:45 a.m. ET
    Lead Author: Bruce Corser MD, FAASM, Medical Director of Intrepid Research, Cincinnati, OH
    Poster Presentation Session: P-16
    Poster Number: 375
  • Title: Solriamfetol for Excessive Daytime Sleepiness in Narcolepsy and OSA: Post-hoc Multi-dimensional Composite Endpoint Analysis of Phase 3 Trials
    Presentation Date and Time: Monday, June 15, 10:00 - 11:45 a.m. ET
    Lead Author: Ellen Wertmer, FNP-BC, DBSM, FAASM, Founder of Restorative Sleep Medicine, Charlottesville, VA
    Poster Presentation Session: P-16
    Poster Number: 386
  • Title: Symptom Burden and Quality of Life in Patients with Narcolepsy Who Experience Residual Cataplexy: Subgroup Analysis from the CRESCENDO Survey
    Presentation Date and Time: Tuesday, June 16, 10:00 - 11:45 a.m. ET
    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 Presentation Session: P-34
    Poster Number: 316

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, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates 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
Senior Director, Investor Relations
(929) 687-1614
[email protected]

Media:
Darren Opland
Senior Director, Corporate Communications
(929) 837-1065
[email protected]


Risks

  • The success and commercial viability of Axsome's products depend on ongoing and future clinical trials and FDA approvals.
  • Market acceptance and payer coverage for Axsome's therapies may fluctuate, impacting revenue projections in the CNS and sleep disorder sectors.
  • Clinical trial timelines and funding assumptions carry uncertainties that could delay or limit product development and launches.

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