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Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-12 in Narcolepsy Supporting NDA Submission
New Drug Application (NDA) submission on track for January 2026 NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a
About this update from Axsome Therapeutics, Inc.
[{"type":"text","content":"New Drug Application (NDA) submission on track for January 2026 NEW YORK, Dec. 31, 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 that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) supporting an NDA submission for AXS-12 in narcolepsy. AXS-12 (reboxetine) 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. “We are pleased with the FDA pre-NDA meeting minutes which allow completion of the NDA submission for AXS-12 for the treatment of cataplexy in patients with narcolepsy shortly in January 2026,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “We are excited by the potential of AXS-12 to provide a new, differentiated treatment option to patients living with this debilitating condition, if approved.” AXS-12’s clinical development program in narcolepsy includes three controlled efficacy trials, and a completed long-term safety trial. AXS-12 has been granted Orphan Drug Designation for the treatment of narcolepsy. Orphan Drug Designation is granted to promising drugs intended for the safe and effective treatment of rare diseases, defined as those affecting fewer than 200,000 people in the U.S. This designation may entitle Axsome to a period of seven years of marketing exclusivity in the U.S. upon FDA approval and a waiver of the Company’s obligation to pay the FDA application user fees for the product as required by the Prescription Drug User Fee Act. About Narcolepsy Narcolepsy is a serious and debilitating orphan neurological condition that causes dysregulation of the sleep-wake cycle and is characterized clinically by excessive daytime sleep...