Axsome Therapeutics (AXSM) received formal pre-New Drug Application meeting minutes from the U.S. Food and Drug Administration supporting an NDA submission for AXS-12 in narcolepsy. AXS-12 is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator. The purpose of the meeting was to reach agreement with the FDA on the proposed content and format of the Company’s planned NDA submission including the clinical and nonclinical requirements. Based on the feedback from the FDA, the Company’s regulatory data package would be sufficient for the submission of an NDA for AXS-12 for the treatment of cataplexy in narcolepsy. Axsome anticipates completing the NDA submission in January 2026. Acceptance of the final NDA will be subject to the FDA’s review of the complete filing.
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