Sarepta Priority Review confirms FDA ‘amenability to approval,’ says RBC Capital

After Sarepta announced that the efficacy supplement for Elevidys to expand its label and convert its approval in 4-5 year olds to a broader traditional approval has been granted a Priority Review with a PDUFA date of June 21 and the company also noted that the FDA confirmed its plan not to hold a related Advisory Committee meeting, RBC Capital analyst Brian Abrahams views the Priority Review “favorably aligning” with CBER head Peter Marks’ recent remarks reflecting permissiveness of the Agency in evaluating gene therapies. The FDA Priority Review with no AdComm looks to support the narrative of FDA amenability to an expanded label for Elevidys, says the analyst, who has an Outperform rating and $151 price target on Sarepta shares.