Needham believes this morning’s data from Axsome Therapeutics (AXSM) “should be adequate for an approvable regulatory package” as management indicated previously that all they need beyond ADVANCE-1 and ACCORD-1 was the safety dataset. However, based on feedback from investors, the ADVANCE-2 miss will be viewed as “falling short of a very solid efficacy package,” the analyst tells investors in a research note. As such, the firm expects pressure on the shares today. However, AXS-05 was not associated with increased rim k of falls, cognitive decline, or sedation, which was one of the concerns in this older patient population, contends Needham. It keeps a Buy rating on Axsome with a $130 price target The stock in premarket trading is down 7% to $80.40.
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