The FDA approved AUVELITY (dextromethorphan HBr and bupropion HCl) for treating agitation in patients with Alzheimer's disease dementia. AUVELITY is a first-in-class treatment targeting NMDA and sigma-1 receptors. Approval is supported by the Phase 3 ADVANCE-1 and ACCORD-2 clinical trials. The drug demonstrated statistically significant improvement in agitation symptoms and a longer time to relapse compared to placebo. The company will host a conference call on May 1, 2026, to discuss the approval.