The FDA accepted Axsome Therapeutics’ supplemental new drug application for AXS‑05 (Auvelity) to treat agitation in Alzheimer’s disease and granted priority review, setting an April 30 PDUFA date. The agency’s acceptance reflects regulators’ view that the submission could address a serious unmet need in dementia care. Axsome’s shares rose sharply on the news. The filing is a label expansion of an existing product and leverages prior clinical data supporting agitation endpoints. A priority review shortens the regulatory timeline and signals the agency sees potential for substantial benefit over available therapies.