Axsome data ‘should be adequate’ for FDA approval, says Needham

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.