Sarepta FDA panel switch not a negative, says William Blair

William Blair analyst Tim Lugo keeps an Outperform rating on Sarepta Therapeutics after the company announced that the FDA intends to hold an Advisory Committee for the ongoing review of SRP-9001 ahead of the March 29 action date. This reverses commentary from two weeks ago where management announced during the Q4 call that the FDA had informed the company it was not planning to hold a panel meeting during its mid-cycle review, the analyst tells investors in a research note. With shares trading down, the change is likely being viewed in a negative light as a panel can suggest the FDA has unresolved questions about the clinical package for which it is seeking the input of external experts, but that does not appear to be the case here, contends Blair. On the call, management highlighted that to the best of its knowledge, the decision was solely to discuss the surrogate endpoint, and that there were no new outstanding issues, it says.