AXSM Up on FDA Priority Review to AXS-05 sNDA in Alzheimer's Agitation

Core Viewpoint - Axsome Therapeutics' shares surged 22.8% following the FDA's acceptance of the supplemental new drug application for AXS-05, aimed at treating agitation in Alzheimer's disease [1][7]. Group 1: FDA Approval Process - The FDA has granted a priority review for the sNDA, with a decision expected by April 30, 2026, reducing the review period to six months [2][7]. - The sNDA is supported by a comprehensive clinical program, including data from four pivotal late-stage studies and a long-term safety study [3][7]. Group 2: Product Performance and Market Potential - AXS-05 is already approved for major depressive disorder and marketed as Auvelity, which generated $352 million in sales during the first nine months of 2025, reflecting a 77.1% year-over-year increase [8]. - Axsome is also exploring additional indications for Auvelity, including smoking cessation, with plans to initiate a pivotal study soon [9][10]. Group 3: Pipeline Developments - Axsome has received FDA feedback on AXS-12, a candidate for treating cataplexy in narcolepsy, with plans to submit a new drug application by January 2026 [11][12].