FDA Fast-Tracks Axsome's Alzheimer's Agitation Drug, Stock Soars

Core Viewpoint - The FDA has accepted Axsome Therapeutics Inc.'s supplemental New Drug Application for AXS-05 for Alzheimer's disease agitation, granting it Priority Review status with a target action date of April 30, 2026 [1][2]. Group 1: AXS-05 Development - The supplemental NDA is based on a comprehensive clinical development program, which includes four randomized, double-blind, controlled Phase 3 clinical trials and a long-term safety trial [3]. - A Priority Review designation means the FDA aims to act on the application within 6 months, compared to 10 months under standard review [2]. Group 2: AXS-12 Regulatory Update - Axsome received formal pre-NDA meeting minutes from the FDA, supporting an NDA submission for AXS-12 in narcolepsy, a chronic neurological condition [4][5]. - The company anticipates completing the NDA submission for AXS-12 in January 2026, with the acceptance of the final NDA subject to FDA review [6]. - AXS-12's clinical development program includes three controlled efficacy trials and a completed long-term safety trial [6]. Group 3: Market Reaction - Axsome Therapeutics shares increased by 18.18% to $175.84, reaching a new 52-week high [7]. - Needham has maintained a Buy rating on Axsome Therapeutics and raised the price forecast from $154 to $169 [6].