The FDA accepted and granted priority review of Axsome Therapeutics’ supplemental NDA for AXS-05 to treat agitation in Alzheimer's disease, assigning a PDUFA date of April 30. The agency’s designation accelerates regulatory timing for a large unmet psychiatric indication and immediately moved Axsome’s shares higher. The filing is based on the company’s clinical program that the company says supports efficacy for agitation in dementia; detailed data disclosures are expected ahead of the PDUFA. Investors and specialty care groups will watch labeling discussions and postapproval risk-management commitments as the review proceeds.