FDA grants priority review for AXS‑05 – Alzheimer’s agitation on an expedited clock

The FDA accepted and granted priority review to Axsome Therapeutics’ supplemental NDA for AXS‑05 to treat agitation in Alzheimer’s disease, setting a PDUFA target date of April 30. The agency’s priority designation reflects the filing’s perceived potential to address an unmet neuropsychiatric need in dementia care. Market response followed immediately, with Axsome shares rising on the filing announcement. Axsome’s submission rests on clinical data the company characterizes as pivotal for agitation endpoints. Priority review shortens the FDA review window and increases regulatory focus; the April PDUFA will be a near‑term readout for clinicians and investors tracking dementia therapeutics.