Replimune Group Completes Type A Meeting With FDA On RP1 BLA For Advanced Melanoma; Path Forward for Accelerated Approval Still Undetermined

Replimune Group, Inc. (NASDAQ:REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the company completed a Type A meeting with the U.S. Food and Drug Administration (FDA) on September 16th to discuss the complete response letter (CRL) for the Company's Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma.

The company is evaluating the feedback from the FDA provided during the meeting to determine next steps. At this time, a path forward under the accelerated approval pathway has not been determined.

"The feedback from the melanoma community, including patients and physicians, clearly highlights the unmet need in advanced melanoma and the compelling risk-benefit profile of RP1 observed in the IGNYTE trial," said Sushil Patel, Ph.D., CEO of Replimune. "We remain committed to working with the FDA to determine an expeditious path forward for RP1."