Sarepta Therapeutic (SRPT) NDA Submission Marks 'Significant De-risking Event', Roth Capital Says

Roth Capital analyst Debjit Chattopadhyay said news that Sarepta Therapeutic (NASDAQ: SRPT) completed the rolling submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for eteplirsen is a "significant de-risking event.' The firm maintained its Buy rating and price target of $45.00.

Chattopadhyay commented, "Sarepta announced the completion of its NDA submission ahead of our mid-July expectation, setting itself up for a late fall panel meeting, and 1Q16, conditional approval. Recall that Sarepta is seeking accelerated and not full approval, which would be contingent upon the ongoing studies. Importantly, despite its poor data and lack of mechanistic rationale (dystrophin), BioMarin is not conducting additional studies, indirectly ceding competitive advantage to Sarepta, in our view."

For an analyst ratings summary and ratings history on Sarepta Therapeutic click here. For more ratings news on Sarepta Therapeutic click here.

Shares of Sarepta Therapeutic closed at $31.26 yesterday.

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