After Axsome Therapeutics (AXSM) reported that its ACCORD-2 trial in Alzheimer’s disease agitation met its the primary endpoint, but that the ADVANCE-2 trial with AXS-05 did not, Leerink called this “the outcome that we were hoping to avoid” as well as “the one that creates the most confusion going forward.” While Auvelity has a chance to be approved in Alzheimer’s disease agitation with the positive data from ADVANCE-1 along with ACCORD-1 and ACCORD-2, it is unclear how the FDA will view the withdrawal studies, says the analyst, who believes that investors “will be somewhat skeptical of approval,” but maintains an Outperform rating on Axsome shares.
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