Axsome Therapeutics, Inc.
Auvelity
agitation associated with dementia due to Alzheimer’s disease
Resolved
68days ago
Approval decision · Apr 30, 2026
What's at stake
A final FDA approval decision on Auvelity for agitation associated with dementia due to Alzheimer’s disease is expected Apr 30, 2026.
Primary source
· SEC 8-K
verified 15h ago
“The U.S. Food and Drug Administration (FDA) has approved AUVELITY (dextromethorphan HBr and bupropion HCl) for the treatment of agitation associated with dementia due to Alzheimer’s disease.”