By Christy Santhosh – Reuters News –
Sarepta Therapeutics (SRPT.O), failed to win the European drug regulator’s backing for its muscle disorder gene therapy on Friday, as the company faces intense regulatory scrutiny after two recent patient deaths tied to the treatment.
Shares of the Cambridge, Massachusetts-based company slumped 11%. They have lost 88.8% so far this year. The EU committee’s negative opinion for Elevidys is yet another major setback for the company, which was directed by the U.S. health regulator earlier this month to stop all shipments of the gene therapy — the only one approved by it for treating Duchenne muscular dystrophy (DMD).
