NasdaqGS:REPLBiotechs
Why Replimune Group (REPL) Is Down 75.0% After FDA Rejects RP1 Melanoma Application And What's Next
Replimune Group, Inc. recently received a complete response letter from the FDA rejecting its Biologics License Application for RP1 plus nivolumab in advanced melanoma, despite earlier breakthrough therapy designation and priority review based on the IGNYTE trial data set.
The company is publicly challenging what it calls inconsistent FDA processes and shifting review teams, highlighting broader tensions around accelerated approvals for oncology drugs.
Next, we’ll examine how the FDA’s...