Axsome Therapeutics won FDA approval expanding Auvelity’s label to include treatment of agitation in Alzheimer’s disease. The approval provides an additional indication for the dextromethorphan-bupropion combination, which has already been used for major depressive disorder. The decision places Auvelity as the second FDA-approved option for Alzheimer’s agitation, following an approval in 2023 for Rexulti (brexpiprazole). Axsome characterized the new label as supportive for broader access in a patient group where available therapies have been limited. As Axsome prepares the launch, investors will be watching uptake speed and safety profile management versus competing options that carry boxed warnings.