Axsome Therapeutics Proudly Supports Migraine and Headache Awareness Month Alongside the Association of Migraine Disorders

NEW YORK, June 16, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, is proud to recognize Migraine and Headache Awareness Month alongside the Association of Migraine Disorders. In honor of this year's theme, "Your Path to Better Days," Axsome is supporting more than a dozen Miles for Migraine Run, Walk or Relax events across the U.S. throughout the month of June and beyond. Axsome is also sharing resources for patients and their loved ones affected by migraine.

"As someone who lives with migraine, I know how isolating, debilitating, and misunderstood this disease can be," said, Kylie Gagan, Director of Education at the Association of Migraine Disorders. "There's a critical need for effective acute treatment options so people can work, attend school, and live their daily lives. Because of the severity and unpredictability of migraine attacks, people often miss out on time with loved ones, work responsibilities, or personal events. The Association of Migraine Disorders is working every day to fund and advance migraine research, educate both patients and providers, and raise awareness about migraine disease worldwide."

Migraine is a debilitating condition characterized by recurrent attacks of pulsating, often severe and disabling head pain, accompanied by nausea, sensitivity to light, and/or sensitivity to sound.¹ Migraine affects approximately 40 million people in the U.S. and is the second leading cause of disability worldwide.^2,3

To help support "Your Path to Better Days" for individuals affected by migraine, Axsome is sharing the following resources from some of the leading migraine advocacy organizations:

• American Migraine Foundation Find a Doctor (https://americanmigrainefoundation.org/find-a-doctor/) is a resource to help patients find medical professionals experienced in migraine and headache care.
• Association of Migraine Disorders Migraine Explainer Videos (https://www.migrainedisorders.org/education/patient-resources/videos/) are educational videos that describe different types of migraines, symptoms, treatments, and pathophysiology.
• CHAMP Financial Assistance Guides (https://headachemigraine.org/migraine-financial-assistance-guides/) outline financial assistance programs operated by pharmaceutical companies and device manufacturers to help patients cover the cost of accessing treatment.
• National Headache Foundation podcast (https://headaches.org/category/podcast/head-wise/) features informative discussions with headache experts on the latest treatment, research, lifestyle recommendations, and personal stories about living with migraine disease and headache disorders.

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:

Mark Jacobson

Chief Operating Officer

(212) 332-3243

[email protected]

Media:

Darren Opland

Director, Corporate Communications

(929) 837-1065

[email protected]

References:

1. Headache Classification Committee of the International Headache Society (IHS) Cephalagia (2018)
2. American Migraine Foundation (2023), https://americanmigrainefoundation.org/, accessed May 2, 2025.
3. Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137.