Axsome leaps on positive AXS-05 Phase III results in Alzheimer's

US central nervous system specialist Axsome Therapeutics (Nasdaq: AXSM) saw its shares rocket more than 32% to $74.84 yesterday, after it announced positive late-stage clinical results with its drug candidate in Alzheimer’s disease agitation.

The company said that AXS-05 (dextromethorphan bupropion), a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the primary and key secondary endpoints in the ACCORD (Assessing Clinical Outcomes in Alzheimer’s Disease Agitation) Phase III trial, by substantially and statistically significantly delaying the time to relapse and preventing relapse of agitation in patients with Alzheimer’s disease, as compared to placebo.

In August this year, AXS-05 was approved in the USA for the treatment of depression under the trade name Auvelity and moving into Alzheimer’s agitation would be an important expansion. Chris Howerton, an analyst at Jefferies, previously predicted the drug could generate as much as $1.8 billion in peak yearly sales.