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Sarepta ‘confident’ on 2014 eteplirsen NDA; no FDA handshake on dystrophin surrogate

This article was originally published in Scrip

Executive Summary

The confidence expressed by Sarepta Therapeutics' CEO on 24 July the firm would be able to submit a new drug application (NDA) to the US FDA in the first half of 2014 for eteplirsen in Duchenne muscular dystrophy (DMD) had early-morning investors wild with excitement – with shares rising 21% in premarket trading.

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