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Axsome Therapeutics (AXSM) received from FDA proposed labeling for AXS-05 product candidate with respect to its NDA for AXS-05 for treatment of major depressive disorder

June 27, 2022 7:17 AM EDT

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Axsome Therapeutics (NASDAQ: AXSM) disclosed:

On June 24, 2022, Axsome Therapeutics, Inc. (the “Company”) received from the U.S. Food and Drug Administration (the “FDA”) proposed labeling for the Company’s AXS-05 product candidate with respect to its New Drug Application (the “NDA”) for AXS-05 for the treatment of major depressive disorder. The Company is reviewing the proposed labeling and will reply to the FDA to secure final labeling agreement.



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