Core Viewpoint - Axsome Therapeutics has received priority review designation from the FDA for its supplemental new drug application to expand the indication of AXS-05 for the treatment of agitation associated with Alzheimer's disease [1][2] Group 1: Company Developments - Axsome Therapeutics announced that the FDA has set a target review completion date of April 30, 2026, for the supplemental new drug application for AXS-05 [1] - Following the announcement, Axsome's stock rose over 7% in pre-market trading [1] - AXS-05 was previously approved by the FDA in 2022 for the treatment of major depressive disorder in adults [1] Group 2: Drug Mechanism and Potential - AXS-05 is an oral NMDA receptor antagonist, sigma-1 agonist, and CYP2D6 inhibitor, combining dextromethorphan and bupropion in a patented formulation [2] - The drug aims to improve symptoms characterized by emotional distress, verbal and physical aggression, irritability, and disinhibition in Alzheimer's disease agitation [2] - The CEO of Axsome expressed optimism about the FDA's acceptance and priority review designation, indicating a commitment to collaborate with the FDA during the review process [2]