We first wrote about the prospect of the company addressing this unmet need here Agitation in Alzheimer's Disease - An Unmet Need. The therapy, if approved could allow easier caregiver services, that keep patients in their home setting, avoiding institutional care. The company completed all phases of clinical trials, and filed a new drug application recently (NDA) for AXS-05 for the indication of Alzheimer's Disease Agitation. Axsome was notified by the FDA that the application has been accepted with priority review and a decision date (PDUFA) of April 30th, 2026. This is great news as it could be the only non-antipsychotic drug to be approved for this indication. Receiving priority review, which includes a shortened time frame for review, increases the chances of approval significantly. The stocks reaction as anticipated, is very positive chart below.
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