FDA approves AUVELITY for treating agitation in Alzheimer's dementia, Axsome hosts investor event.

Axsome Therapeutics announced FDA approval of AUVELITY, a first-in-class oral treatment for agitation associated with dementia due to Alzheimer's disease. AUVELITY targets NMDA and sigma-1 receptors and was previously approved for major depressive disorder. The company held a virtual investor event featuring expert Dr. Jeffrey Cummings to discuss the drug's clinical benefits and commercial plans. This approval addresses a significant unmet need, as agitation affects up to 76% of Alzheimer's patients and contributes to faster cognitive decline and caregiver burden.