NasdaqGM:AXSMPharmaceuticals
FDA Acceptance of AXS-12 NDA for Narcolepsy Might Change The Case For Investing In Axsome (AXSM)
Axsome Therapeutics recently reported that the FDA accepted for filing its New Drug Application for AXS-12 (reboxetine) to treat cataplexy in narcolepsy, with a Prescription Drug User Fee Act target action date set for May 1, 2027, and no advisory committee meeting currently planned.
This regulatory milestone advances Axsome’s late-stage pipeline in a serious orphan neurological condition, potentially reinforcing the company’s focus on differentiated central nervous system therapies.
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