Sarepta Therapeutics, Inc. Loss Form

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    On August 19, 2019, Sarepta announced receipt of a Complete Response Letter (“CRL”) from the U.S. Food & Drug Administration regarding the Company’s New Drug Application seeking accelerated approval of golodirsen injection for the treatment of Duchenne muscular dystrophy. Sarepta disclosed that “[t]he CRL generally cites two concerns: the risk of infections related to intravenous infusion ports and renal toxicity seen in pre-clinical models of golodirsen and observed following administration of other antisense oligonucleotides.”

    Following this news, Sarepta’s stock price fell over 15%.