Axsome Therapeutics’ Auvelity gained U.S. FDA approval for treating agitation in Alzheimer’s disease, expanding the drug’s label beyond its existing major depressive disorder indication. The approval establishes Auvelity as the second FDA-approved therapy for Alzheimer’s agitation, following Rexulti (brexpiprazole). The update comes with a reported wholesale acquisition cost of $1,248 for a 30-day supply and is scheduled for launch in June. For Axsome, the decision adds access to a large market segment, where labeling and safety positioning can materially influence adoption. The approval follows a competitor’s existing boxed warning context in the agitation space, which may affect prescribing dynamics. The label expansion keeps Axsome’s lead small-molecule combination strategy in the spotlight while reinforcing competitive pressure on other behavioral symptom treatments in neurodegenerative disease.