Replimune Group

Rule Changes

Won FDA accelerated approval for Tudriqev on August 6 and is preparing a commercial launch within about 60 days.

The FDA granted accelerated approval on August 6 to Replimune's tumor-injected virus therapy, now sold as Tudriqev, after rejecting it twice. An advisory panel had voted 10-3 on July 30 that the trial data were reliable enough to support approval, despite FDA staff's earlier doubts.

Updated Aug 8