India, July 22 -- Shares of Replimune Group Inc. (REPL) are down more than 76 percent in the pre-market activity on the Nasdaq after the clinical stage biotechnology company focused on oncolytic immunotherapies announced Tuesday that it has received a Complete Response Letter or CRL from the U.S. Food and Drug Administration.
The CRL is regarding the Biologics License Application or BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.
The company said it plans to request a Type A meeting and expects it will be granted within 30 days. Replimune plans to urgently interact with the FDA to find a path forward for the timely accelerated approval of RP1 without which the development of RP...