BUZZ-Replimune falls after FDA staff flags efficacy concerns about skin cancer therapy
REPL•Prior rejection and stock performance
In April, the health regulator declined to approve the drug for a second time, citing insufficient data from studies.
Up to last close, the stock was down 11.2% year to date.
FDA staff raises efficacy concerns on RP1 trial
Shares of drug developer Replimune REPL.O fell 21% to $6.93 premarket after U.S. FDA staff said the clinical trial conducted for Replimune's therapy, RP1, did not provide substantial evidence that it works when combined with Bristol Myers Squibb's BMY.N nivolumab in advanced melanoma.
The staff's findings were published in briefing documents released ahead of an advisory committee meeting on Thursday, where a panel of outside experts will discuss the therapy's benefits.
Reviewers question how tumor responses were measured
Reviewers said the way the tumor responses were measured may have inflated the study's reported response rate and durability of responses.
FDA staff also said the trial could not determine whether RP1, rather than nivolumab alone, drove the observed benefit.
