Press Release Details

NEW YORK, May 07, 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 its support for Mental Health Month alongside the broader mental health advocacy community. In recognition of this year’s More Good Days Together theme, Axsome is sharing resources to support individuals affected by mental health conditions, their families, and the communities around them.

“At Mental Health America, we are proud to have established Mental Health Month in 1949, with the goal of educating the public about mental illness, mental health, and recovery,” said Pierluigi Mancini, PhD, interim president and CEO of Mental Health America (MHA). “Our 2026 campaign, More Good Days, Together, provides tools and resources that meet people where they are, support them as whole people, and acknowledge that 'good' is defined by their unique experience and goals. The path may look different for everyone, but we all deserve more good days, together."

Mental health conditions are highly prevalent in the U.S., with nearly 1 in 4 adults living with a mental illness.¹ Major depressive disorder (MDD), one of the most common mental health conditions, is a leading cause of disability worldwide and impacts over 21 million adults in the U.S. alone.^1-3 Nearly 90% of people living with depression report difficulty with work, home, or social activities due to their symptoms, underscoring the impact depression can have on day-to-day life.⁴

Axsome’s mission is to develop and deliver transformative medicines to improve the brain health of millions of individuals affected by central nervous system conditions, including those living with difficult-to-treat mental illness. To help raise awareness and promote action during Mental Health Month, Axsome is highlighting non-profit organizations and resources that provide education, tools, and community support for individuals and families affected by mental health conditions, including:

• 2026 Mental Health Month Action Guide (https://mhanational.org/2026-mental-health-month-action-guide/) MHA’s work is driven by its commitment to promote mental health as a critical part of overall wellness, including prevention services for all; early identification and intervention for those at risk; and integrated care, services, and support for those who need them, with recovery as the goal. Its 2026 Mental Health Month Action Guide provides access to online activities, articles, printable tools, and practical resources
• Anxiety and Depression Association of America (ADAA)’s “Find Your Therapist” platform (https://findyourtherapist.adaa.org/) helps connect people with licensed mental health professionals who specialize in treating anxiety, depression, OCD, PTSD, and other related disorders. This aligns with ADAA’s 2026 annual conference theme around “Innovations in Technology Driving Clinical Care and Research in Mood and Anxiety Disorders,” and the organizations commitment to improving live through collaboration, research, education, and innovation.   
• The National Alliance on Mental Illness (NAMI) New York Chapter (https://naminycmetro.org/), guided by lived experience and evidence-based practices, helps families and individuals affected by mental illness build better lives through education, support, and advocacy. Later this month NAMI-NYC is hosting its annual Mental Health Street Fest, which is the nation’s largest mental health event, being held since 2007: https://www.namiwalks.org/nyc.
  

If you or someone you know is in crisis, the 988 Suicide & Crisis Lifeline (https://988lifeline.org/) is a free confidential support service available 24 hours a day, 7 days a week across the United States. When people call, text, or chat 988, they will be connected to trained counselors that are part of the existing Lifeline network. These trained counselors will listen, understand how their problems are affecting them, provide support, and connect them to resources if necessary.

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
adong@axsome.com

Media:
Darren Opland
Senior Director, Corporate Communications
(929) 837-1065
dopland@axsome.com

References:

1. Substance Abuse and Mental Health Services Administration. Key Substance Use and Mental Health Indicators in the United States: Results from the 2023 National Survey on Drug Use and Health. July 2024. https://www.samhsa.gov/data/report/2023-nsduh-annual-national-report
2. World Health Organization. Depression and Other Common Mental Disorders: Global Health Estimates. 2017.https://www.who.int/publications/i/item/depression-global-health-estimates
3. National Institute of Mental Health. Major Depression. Accessed February 2026. https://www.nimh.nih.gov/health/statistics/major-depression
4. Brody DJ, Hughes JP. Depression prevalence in adolescents and adults: United States, August 2021–August 2023. 2025 Apr; (527)1–11. DOI: https://dx.doi.org/10.15620/cdc/174579.

Source: Axsome Therapeutics, Inc.