Axsome building body of evidence in Alzheimer’s agitation

Although doubts remain that Axsome’s second positive readout in its Phase III program in Alzheimer’s agitation will be enough to gain approval, the public markets rewarded the biotech by adding almost $780 million to its market cap Monday.

Axsome Therapeutics Inc. (NASDAQ:AXSM) announced results from the downsized Phase III ACCORD study of AXS-05, its formulation of dextromethorphan and buproprion, to treat agitation associated with Alzheimer’s disease. Compared with placebo, the therapy significantly delayed time to relapse, meeting the study’s primary endpoint (HR=0.275; p=0.014); it also met a secondary endpoint by reducing the likelihood of relapse (25.9% vs. 7.5%, p=0.018)...