Sarepta shares fall on potential regulatory delay for experimental Duchenne drug

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Shares of Sarepta Therapeutics Inc. were down 0.7% in premarket trading on Thursday, the day after the company said it had submitted a written response to the Food and Drug Administration for its investigational Duchenne muscular dystrophy treatment. The regulator had asked Sarepta to use an additional assay before patients are dosed in the trials. Analysts say the regulatory request will slow down Sarepta’s timeline for seeking approval for its gene therapy, with some saying the lag time for the initiation of the Phase 3 trial could give a competitive boost to Pfizer Inc. experimental DMD therapy, according to Raymond James analyst Danielle Brill. “We don’t think Sarepta will have trouble getting through this; and we expect just a limited delay,” Bernstein’s Vincent Chen wrote in a note to investors on Thursday. “Our sense is Sarepta has plenty of options for potential potency release assays; it’s just a matter of aligning with the FDA, and validating the assays.” Sarepta’s stock is up 1.1% so far this year, while the S&P 500 has gained 5.2%.
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