Baird Upgrades SRPT After Positive Signal That FDA Is Ready To Review

In a report published Wednesday, Baird analysts upgraded Sarepta Therapeutics, Inc. (NASDAQ: SRPT). The price target was raised from $16 to $20. The upgrade follows the NDA submission by the company's competitor BioMarin Pharmaceutical, Inc. (NASDAQ: BMRN)."We think this signals that the FDA is ready to review both applications and expect Sarepta to be able to solidify a mid-2015 submission following a 2Q meeting with the agency," the analysts said.The analysts believe that an NDA submission would offer upside to the stock. The fact that the FDA has accepted BioMarin's drisapersen NDA suggests that the FDA is now open to reviewing exon skipping medication. This could be a positive for Sarepta when it files an NDA in a few months. Baird also believes that the FDA is likely to allow Sarepta's NDA submission for eteplirsen given that the agency did not publicly raise any objection to Sarepta conducting a fourth biopsy on 11 children in its Phase 2 study. This is especially significant because of the invasive nature of the surgery involved and the amount of muscle sample needed from children who were also losing muscle mass due to their disease.