6 June 2016 - Sarepta Therapeutics today announced that the U.S. FDA has requested that Sarepta provide dystrophin data, as measured by western blot, from biopsies already obtained from the ongoing confirmatory study of eteplirsen (Promovi), as part of its ongoing evaluation of the eteplirsen new drug application.
The Company plans to submit data from thirteen patient biopsy samples, at baseline and Week 48, to the FDA over the coming weeks to facilitate a prompt decision on the new drug application by the FDA.
For more details, go to: http://investorrelations.sarepta.com/phoenix.zhtml?c=64231&p=irol-newsArticle&ID=2175522