Axsome Therapeutics, Inc.
AUVELITY
agitation associated with dementia due to Alzheimer’s disease
Date
TBD
FDA decision · Date TBD estimated
What's at stake
The FDA's approval decision on AUVELITY for agitation associated with dementia due to Alzheimer’s disease is due Date TBD. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 15h ago
“The FDA approval of AUVELITY for agitation associated with dementia due to Alzheimer’s disease is supported by a comprehensive clinical program which included the Phase 3 ADVANCE-1 and ACCORD-2 studies.”