BofA lowered the firm’s price target on Sarepta to $164 from $169 and keeps a Buy rating on the shares after the company announced that the FDA has changed its prior stance and now intends to hold an advisory committee meeting, or ad com, for SRP-9001. This “quick pivot gives us a bit of whiplash,” but the firm had always assumed an ad com was likely and thinks Sarepta is “well-prepared,” the analyst tells investors. The logistics of scheduling an ad com increases the burden on the agency for what is already a short review timeline, so the firm thinks the likelihood of a three month PDUFA extension is higher post the ad com for logistical reasons, though this does not change BofA’s view on the approvability of ‘9001.
Published first on TheFly
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