Axsome Therapeutics Inc AXSM shares are trading higher Monday morning after the company announced AXS-05 achieved its primary endpoint in the ACCORD Phase 3 trial in Alzheimer's disease agitation.
AXS-05 is Axsome's novel, oral, investigational NMDA receptor antagonist with multimodal activity. It met its primary endpoint as well as key secondary endpoints in the ACCORD (Assessing Clinical Outcomes in Alzheimer's Disease Agitation) Phase 3 trial by substantially and statistically significantly delaying the time to relapse and preventing relapse of agitation in patients with Alzheimer's disease.
"The ACCORD results complement, and are consistent with, those from the previously completed positive ADVANCE-1 trial. We intend to discuss these findings with the FDA in the context of the ongoing clinical development of AXS-05 in this indication," said Herriot Tabuteau, CEO of Axsome.
Axsome is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders.
AXSM Price Action: Axsome has a 52-week high of $71.98 and a 52-week low of $20.63.
The stock was up 17.1% at $66.55 at time of publication, according to Benzinga Pro.
Photo: Konstantin Kolosov from Pixabay.
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