15 July 2026 - Axsome Therapeutics today announced that the US FDA has accepted for filing the Company’s new drug application for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. 

The FDA has set a PDUFA target action date of 1 May 2027. The FDA also indicated that it does not currently plan to hold an advisory committee meeting to discuss the application.

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