Axsome says FDA accepts AXS-12 narcolepsy cataplexy NDA, sets May 1, 2027 PDUFA date
AXSM•FDA accepts AXS-12 NDA for review
Axsome Therapeutics’ NDA for AXS-12 (reboxetine) to treat cataplexy in narcolepsy was accepted for FDA review.
The FDA set a PDUFA target action date of May 1, 2027.
No advisory committee currently planned
The agency does not currently plan to convene an advisory committee meeting for the application.
