
The US Food and Drug Administration (FDA) and clinical-stage biotech Replimune (Nasdaq: REPL) have aligned on a path forward for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.
The news sent Replimune’s shares soaring nearly 86% to $8.69 by close of trading Friday.
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