Sarepta completes NDA submission for Duchenne drug eteplirsen
US RNA-based drug developer Sarepta Therapeutics (Nasdaq: SRPT) says it has completed the rolling submission of a New Drug Application to the US Food and Drug Administration for eteplirsen on June 26, 2015.
Roth Capital analyst Debjit Chattopadhyay, quoted by StreetInsider, said the news on eteplirsen is a "significant de-risking event.” The firm maintained its Buy rating and price target of $45.00. Notwithstanding, Sarepta’s shares dropped 4.1% to $29.98 in morning trading today.
Eteplirsen, Sarepta’s lead drug candidate, targets the underlying cause of Duchenne muscular dystrophy (DMD) and is designed to enable the production of a functional internally truncated dystrophin protein in patients with mutations amenable to exon 51 skipping. Approximately 13% of people with Duchenne muscular dystrophy are estimated to have a mutation targeted by Eteplirsen/exon 51 skipping.
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