Sarepta Reports Negative CHMP Opinion For EXONDYS - Quick Facts

(RTTNews) - Sarepta Therapeutics, Inc. (SRPT) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a negative opinion for EXONDYS (eteplirsen). The company previously reported that a negative opinion was anticipated following the oral explanation trend vote. Sarepta will request a re-examination of the opinion, which will result in the assignment of a new rapporteur and co-rapporteur. The re-examination process is expected to be completed by year-end 2018.

EXONDYS is designed to treat patients with Duchenne muscular dystrophy amenable to skipping exon 51 of the dystrophin gene.