(Reuters) -Europe’s medicines regulator did not recommend the approval of Sarepta Therapeutics’ gene therapy Elevidys for a type of rare muscular dystrophy, the health agency said on Friday.
Shares of the company were down nearly 17% at $10.70 in premarket trading.
The EU committee’s negative opinion comes as yet another setback for the company that is facing increasing regulatory scrutiny after two recent deaths of patients who received Elevidys.
Sarepta and its partner outside the U.S., Roche, did not immediately respond to Reuters’ requests for comment.
(Reporting by Christy Santhosh in Bengaluru; Editing by Shilpi Majumdar)
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