Axsome Therapeutics, Inc. (AXSM) announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA). The FDA feedback supports the company's planned NDA submission for AXS-12 in narcolepsy. AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor as well as a cortical dopamine modulator. The meeting was held to establish agreement with the FDA on the proposed content and format of the NDA, including clinical and nonclinical requirements.
Following the FDA's guidance, Axsome's regulatory data package is considered sufficient to support an NDA submission for AXS-12 for the treatment of cataplexy in narcolepsy. The company anticipates completing the NDA submission in January 2026, with acceptance of the filing subject to the FDA's review of the full application.
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.
AXSM closed trading on the NasdaqGM at $148.79, reflecting a decline of $1.89 or 1.25% as of December 30. In pre-market trading, the stock was slightly lower at $148.70, down $0.09 or 0.06%.
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