Axsome Therapeutics Recognizes Mental Illness Awareness Week Along with the National Advocacy Community

NEW YORK, Oct. 09, 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 recognizing Mental Illness Awareness Week (MIAW) alongside the national mental health advocacy community including the National Alliance on Mental Illness (NAMI). This year’s theme for MIAW is “Building Community: Supporting Mental Well-being Together,” to highlight the importance of meaningful connections, the value of grassroots advocacy, and impact of local action to strengthen mental health support within communities.

"Mental health matters every day. But during MIAW, we come together to raise awareness, support one another, and build stronger communities. NAMI is dedicated to providing advocacy, education, support, and public awareness so that all individuals and families affected by mental illness can build better lives," said Jessica Edwards, NAMI’s Chief Development Officer.

In the spirit of the MIAW theme of community building, Axsome is sharing resources and programs offered by NAMI that provide free support for people who need it most:

NAMI’s Sharing Hope is a program that provides encouragement and connection for individuals and families.
NAMI’s Compartiendo Esperanza is a Spanish-language initiative providing culturally relevant support and resources for Latino communities.
NAMI’s Support Groups are peer-led groups offering emotional support, shared experiences and coping strategies for individuals living with mental health conditions, and their loved ones.
NAMI’s Community Health Equity Alliance advances mental health equity by uniting community-based organizations, thought leaders, and NAMI’s local affiliates to improve care for Black/African ancestry adults living with serious mental illness.
Seize the Awkward is a national campaign driven by the belief that young people have the power to support their friends and build stronger, more supportive communities through open mental health conversations, developed with the Ad Council and the American Foundation for Suicide Prevention.

Mental health conditions continue to have a significant impact in the United States where more than 1 in 5 adults experience mental illness each year.¹ In addition, more than 1 in 7 youth, ages 6-17, experience a mental health condition each year.² 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, underscoring the impact that depression has in the U.S.³

Since its founding, Axsome has been committed to the millions of individuals living with mental health conditions, their loved ones, and the healthcare providers involved in their wellness journeys. In support of its mission to deliver transformative medicines for people impacted by CNS conditions, Axsome partners with leading national and global advocacy organizations on the shared goal of strengthening communities, and to help reduce stigma, raise awareness, and provide valuable resources and support to those affected by mental health challenges.

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

References:

NIH Mental Illness website. https://www.nimh.nih.gov/health/statistics/mental-illness, accessed September 24, 2025.
NAMI Mental Health By the Numbers website. https://www.nami.org/about-mental-illness/mental-health-by-the-numbers/, accessed September 24, 2025.
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.

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