FDA Fast-Tracks Axsome's Alzheimer's Agitation Drug, Stock Soars
On Wednesday, the U.S. Food and Drug Administration (FDA) accepted Axsome Therapeutics Inc.’s (NASDAQ:AXSM) supplemental New Drug Application (NDA) for AXS-05 (dextromethorphan HBr and bupropion HCl) for Alzheimer’s disease agitation.
The FDA granted the application Priority Review designation and set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026.
A Priority Review designation means the FDA’s goal is to take action on an application within 6 months, compared to 10 months under standard review.
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The supplemental NDA is the culmination of a comprehensive clinical development program of AXS-05 in Alzheimer’s disease agitation, including four randomized, double-blind, controlled Phase 3 clinical trials and a long-term safety trial.
AXS-12 Regulatory Update
On Wednesday, Axsome Therapeutics received formal pre-New Drug Application (NDA) meeting minutes from the FDA supporting an NDA submission for AXS-12 in narcolepsy.
Narcolepsy is a chronic neurological condition causing uncontrollable daytime sleepiness, sudden sleep attacks, and fragmented nighttime sleep.
The purpose of the meeting was to reach an 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.
AXS-12’s clinical development program in narcolepsy includes three controlled efficacy trials and a completed long-term safety trial.
Needham maintains a Buy rating on Axsome Therapeutics and raises the price forecast from $154 to $169.
AXSM Price Action: Axsome Therapeutics shares were up 18.18% at $175.84 at the time of publication on Wednesday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
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