Press Release Details

NEW YORK, May 01, 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 it is joining with Mental Health America (MHA) and the broader mental health advocacy community in a consolidated effort to raise awareness and promote action during May’s Mental Health Month.

On May 1, as part of Mental Health America’s “Light Up Green” initiative, Axsome’s New York City headquarters, the One World Trade Center building, will be lit in green, the color for mental health awareness, and through the building’s Spireworks program.

“Mental Health America’s 2024 data confirm what we already know to be true: We are in a mental health crisis that can affect anyone, anywhere,” said Schroeder Stribling, president and CEO of Mental Health America. “Mental health is health, and it affects us all. There are many social and environmental stressors impacting individuals and families across the country—whether you’re someone who lives in a remote rural community, a young person facing online bullying, or someone who is bearing the weight of family financial strain, one’s mental health is directly impacted. We hope that our Mental Health Month resources shine a light on these issues and support the needs of those who are seeking to understand and improve their mental health.”

The impact of mental health conditions is significant in the United States, with nearly 1 in 4 adults in the U.S. living with a mental illness.¹ More than 1 in 8 people aged 12 or older in the U.S. felt depressed in the past two weeks, according to a recent study, highlighting the ubiquity and significant impact that depression has in the U.S.² In particular, nearly 90% of people living with depression report at least some difficulty with work, home or social activities due to their symptoms, contributing to the challenge of keeping up with day-to-day life.²

Axsome’s mission is to improve the lives of individuals living with serious CNS conditions that are difficult to treat or have limited treatment options by developing innovative evidence-based treatments that offer meaningful improvements to the standard of care. And, in the spirit of this year’s Mental Health Month theme of “Turning Advocacy into Action,” Axsome is highlighting the following resources for individuals and communities to take action for themselves or others:

• Mental Health America’s Mental Health Month Action Guide (https://mhanational.org/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. Resources to take action for your or others’ personal mental well-being provided by the MHA include its Online Screening Tools, Youth Leadership Programs and the opportunity to become a mental health advocate.
• Anxiety and Depression Association of America’s (ADAA) Mental Health Webinars (https://adaa.org/resources-news/from-adaa-experts/webinars) can address your questions about mental health conditions. ADAA’s mission focuses on improving quality of life for those with anxiety, depression, OCD, PTSD, and co-occurring disorders through education, practice, and research. ADAA’s resources also include free online peer support groups.
• National Alliance on Mental Illness’ (NAMI) Mental Health Awareness Month Campaign (https://www.nami.org/get-involved/awareness-events/mental-health-awareness-month/). NAMI is the nation’s largest grassroots mental health organization dedicated to building better lives for the millions of Americans affected by mental illness. NAMI is also asking people to share their story as part of their “In Every Story, There’s Strength” campaign. You can learn more about the campaign and submit a short story to NAMI here.
  

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, 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 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:
Mark Jacobson
Chief Operating Officer
(212) 332-3243
mjacobson@axsome.com

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

References:

1. SAMHSA (2023) Key Substance Use and Mental Health Indicators in the United States: Results from the 2023 National Survey on Drug Use and Health, Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration.
2. 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.