BioCentury
ARTICLE | Financial News

Sarepta shares spike on eteplirsen news

May 21, 2015 1:56 AM UTC

Sarepta Therapeutics Inc. (NASDAQ:SRPT) soared $9.86 (60%) to $26.24 on Wednesday after the company said late Tuesday it had agreed with FDA on a rolling NDA submission for eteplirsen ( AVI-4658) to treat Duchenne muscular dystrophy (DMD). The company will begin the submission this week and plans to complete the NDA by mid-year (see BioCentury Extra, May 19).

Eteplirsen, a phosphorodiamidate morpholino oligomer (PMO) targeting exon 51, has Orphan Drug designation in the U.S. and EU and Fast Track designation int he U.S. to treat DMD. ...