AXSM Gets Positive FDA Feedback for Alzheimer's Agitation Drug Filing

Core Viewpoint - Axsome Therapeutics is progressing towards submitting a supplemental new drug application (sNDA) for AXS-05 as a treatment for agitation in Alzheimer's disease, with expectations to file in Q3 2025 [1][2]. Group 1: Regulatory and Clinical Developments - The FDA has provided formal feedback indicating that Axsome's regulatory data package is sufficient for the sNDA submission for AXS-05 in agitation associated with Alzheimer's disease [1]. - The sNDA will be supported by data from four pivotal late-stage studies demonstrating a statistically significant delay in the time to relapse of agitation in Alzheimer's patients compared to placebo [3]. Group 2: Product Performance and Market Potential - AXS-05 is already approved for treating major depressive disorder (MDD) and has generated $291 million in sales since its launch, reflecting a 124% year-over-year increase [4][7]. - The company is also exploring the expansion of Auvelity's label for other CNS disorders, including smoking cessation, with plans to initiate a pivotal study later this year [8][9]. Group 3: Stock Performance - Shares of Axsome Therapeutics have increased by over 50% in the past year, significantly outperforming the industry growth of 6% [5].