Axsome Therapeutics Soars on FDA Accelerated Review for Alzheimer’s Drug
Axsome Therapeutics shares surged nearly 23% after the FDA granted priority review for AXS-05, a potential treatment for Alzheimer's agitation. The agency set an April 2026 PDUFA date, signaling accelerated regulatory momentum for the dextromethorphan-bupropion combination therapy.
Analysts raised price targets to $217, citing both the drug's market potential in a condition affecting up to 76% of Alzheimer's patients and Axsome's broader pipeline strength. Trading volume hit 3.1 million shares despite holiday market closures, reflecting strong investor conviction.
The therapy's existing approval for depression under the Auvelity brand provides commercial infrastructure for rapid Alzheimer's indication rollout if approved. Market watchers now track execution risks against macro conditions in biotech investing.
