The FDA accepted Axsome Therapeutics’ supplemental NDA for AXS-05 (Auvelity) to treat agitation in Alzheimer’s disease and granted priority review, setting a PDUFA target of April 30. The designation reflects the agency’s view of the unmet need for treatments for Alzheimer’s agitation and could accelerate regulatory timing if Axsome addresses outstanding questions. Investors responded with sizable share movement upon the filing acceptance.