26 June 2020 - Axsome now granted two breakthrough therapy designations for AXS-05 for separate CNS indications.
Axsome Therapeutics, today announced that the U.S. FDA has granted breakthrough therapy designation for AXS-05 for the treatment of Alzheimer’s disease agitation.
AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity. There is currently no approved treatment for Alzheimer's disease agitation.