Axsome Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) for AXS-05 seeking approval for the treatment of agitation associated with Alzheimer’s disease, and has granted Priority Review designation to the filing. The regulatory body has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026, underlining the importance of this potential new therapy in an area of high unmet need.
AXS-05, a combination of dextromethorphan hydrobromide and bupropion hydrochloride, is already known for its role in Axsome’s Auvelity therapy and is now being evaluated for its utility in managing agitation symptoms in Alzheimer’s disease, a condition that affects a large majority of patients and significantly complicates care and quality of life. With current treatment options limited, the FDA’s Priority Review designation signals that AXS-05 could represent a meaningful advancement in therapeutic options if approved.
In financial markets, Axsome’s stock responded robustly to the news, with shares rising sharply upon announcement as investors welcomed the accelerated regulatory pathway and the commercial potential of a first-in-class therapy for Alzheimer’s agitation. It is noted that achieving a Priority Review status often correlates with heightened investor confidence in a company’s late-stage pipeline and regulatory execution.
Beyond Alzheimer’s agitation, Axsome continues to advance its broader pipeline of CNS therapies. The company also released positive feedback from the FDA supporting its planned New Drug Application submission for AXS-12 in narcolepsy later this month, and remains engaged in multiple clinical programs across migraine, depression, and other neurologic conditions.
With the April 30, 2026 action date approaching, stakeholders will be closely watching the FDA’s review outcomes for AXS-05, which, if approved, would address a significant clinical gap and potentially extend Axsome’s footprint in the neuropsychiatric treatment landscape.
