Sarepta Therapeutics (SRPT) will submit an NDA in H1 2014 for eteplirsen. The company says it...

|About: Sarepta Therapeutics, Inc. (SRPT)|By:, SA News Editor

Sarepta Therapeutics (SRPT) will submit an NDA in H1 2014 for eteplirsen. The company says it had "productive interactions with the FDA" this week, but notes the regulator "requested additional information related to the methodology and verification of dystrophin quantification." Furthermore, the FDA "would not commit to declaring dystrophin an acceptable surrogate endpoint," although TheStreet's Adam Feuerstein notes the agency "could easily approve the drug instead based on the convincing and positive benefit observed in walking ability." Conference call going on now. Shares +4.6% premarket. Also watch RNA today.