Jun. 11 at 4:38 AM
$REPL I "The resubmission, described as imminent,"
Massachusetts-based Replimune Group (Nasdaq: REPL) has announced plans to resubmit a Biologics License Application (BLA) to the US FDA for Rp1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 based therapy. The resubmission, described as imminent, follows what the company characterized as productive dialogue with the agency and represents a renewed attempt to secure approval for an oncolytic immunotherapy in a patient population with limited post-checkpoint options.
When will be the Resubmission?