Axsome shares rocket up on a surprise win for late-stage Alzheimer’s agitation study — but this is no easy layup
Shares of Axsome Therapeutics $AXSM shot up Monday morning on the surprise news that its lead drug scored statistically significant results for Alzheimer’s agitation, a relatively green field in drug R&D, in what’s billed as a pivotal Phase II/III trial. But the company will have plenty of high-risk work to do before it can expect an FDA approval.
Coming off the ropes of a late-stage fail for AXS-05 in treatment-resistant depression, the biotech reports that their drug scored well against a placebo based on a caregiver-rated scale of Alzheimer’s patients’ behavior, which includes tracking episodes of screaming or hitting. At week 5 researchers tracked mean reductions from baseline of 15.4 points for AXS-05 and 11.5 points for placebo, giving them a p value of 0.010.
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