Axsome Therapeutics to Report Fourth Quarter and Full Year 2024 Financial Results on February 18

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NEW YORK, Jan. 22, 2025 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. announced… (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it will report its fourth-quarter and full-year 2024 financial results on Tuesday, February 18, 2025, before the opening of the US financial markets. Axsome management will then host a conference call at 8:00 a.m. ET to discuss these results and provide a business update.

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To participate in the live conference call, please call (877) 405-1239 (local toll-free) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the “Webcast and Presentations” page in the “Investors” section of the Company’s website at www.axsome.com. A rebroadcast of the conference call will be available on the Company’s website for approximately 30 days after the live event.

About Axum Remedies

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of diseases of the central nervous system. We advance scientific breakthroughs by identifying critical gaps in care and developing differentiated products with an emphasis on novel mechanisms of action that enable meaningful progress in patient outcomes. Our leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy, and obstructive sleep apnea, and multiple late-stage development programs that address a broad range of serious neuropsychiatric conditions affecting more than 150 million people in the United States. Together, we’re on a mission to solve some of the brain’s biggest problems so patients and their loved ones can thrive.

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Forward-looking statements

Certain matters discussed in this press release are “forward-looking statements.” The Company may, in some cases, use terms such as “anticipates,” “believes,” “potential,” “ongoing,” “estimates,” “anticipates,” “anticipates,” “plans,” “intends,” and “may.” Or “could,” “may,” “will,” “should,” or other words that convey uncertainty about future events or results identify such forward-looking statements. In particular, the Company’s statements regarding potential future trends and results are examples of such forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, the continued commercial success of the Company’s Sunosi® and Auvility® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AX-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 existing product candidates, including statements regarding the timing of initiation and pace of enrollment and completion of trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes in the Company’s current projected revenues or expenses), futility analyzes and the 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 needed to support a New Drug Application (“NDA”) submission. For any of the candidates the Company’s current product portfolio, including data regarding ACCORD’s ability and clinical trial development to support an NDA filing for Alzheimer’s disease; the Company’s ability to fund additional clinical trials to further develop the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain approval by the U.S. Food and Drug Administration (“FDA”) or other regulatory authority, or other action with respect to the Company’s product candidates, including statements regarding the timing of any non-disclosure agreement filing; Whether the issues identified by the FDA in the full response letter may impact the Company’s potential NDA approval of AXS-07 for the acute treatment of migraine in adults with or without aura, as assessed by the Company’s proprietary protocol for the MOMENTUM clinical trial; the Company’s ability to successfully defend its intellectual property or obtain necessary licenses at a cost acceptable to the Company, if any; Successful implementation of the Company’s R&D and collaboration programmes; the success of the Company’s licensing agreements; Market acceptance of the Company’s products and product candidates, if approved; the Company’s expected capital requirements, including the amount of capital required for the continued commercialization of Sunosi and Auvility and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s expected cash runway; the Company’s ability to convert sales into recognized revenue and maintain adequate total net sales; Unforeseen circumstances or other disruptions to normal business operations arising from or related to the local political climate, geopolitical conflicts, global pandemic and other factors, including general economic conditions and regulatory developments, that are not within the Company’s control. The factors discussed here could cause actual results and developments to differ materially from those expressed or implied in such statements. Forward-looking statements are made only as of the date of this press release, and the Company undertakes no obligation to publicly update these forward-looking statements to reflect subsequent events or circumstances.

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

Media:
Darren Upland
Director of Corporate Communications Department
(929) 837-1065
dopland@axsome.com

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