Replimune to Resubmit Skin Cancer Drug Application to FDA
Replimune reached an agreement with the FDA to resubmit its marketing application for the skin cancer drug RP1 after two previous rejections. Shares rose nearly 68% following the news that the regulator will prioritize the review of the therapy when used with Bristol Myers Squibb's Opdivo.
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REPLIMUNE GROUP INC shares rose nearly 68% Friday after reaching an agreement to resubmit its skin cancer drug application to the United States regulator. The FDA twice declined to approve the therapy, most recently in April, citing the lack of a well-controlled trial. A successful resubmission would mark the drug's third regulatory attempt and provide a new combination therapy option for the estimated 112,000 Americans diagnosed with melanoma annually.
