The FDA approved Axsome Therapeutics’ Auvelity (AXS-05) for Alzheimer’s disease agitation, expanding the therapy’s label beyond major depressive disorder. The approval gives Auvelity access to a large commercial indication and places a second treatment option on the Alzheimer’s agitation market, alongside existing therapies with different safety profiles. Axsome’s label update also arrives as the company works to defend competitiveness in a crowded neuropsychiatric space where payers and clinicians increasingly distinguish on efficacy and tolerability by patient subgroup.