Replimune falls after FDA staff flags efficacy concerns about skin cancer therapy
BUZZ-Replimune falls after FDA staff flags efficacy concerns about skin cancer therapy ** Shares of drug developer Replimune REPL.O fall 21% to $6.93 premarket
** U.S. FDA staff says 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 say the way the tumor responses were measured may have inflated the study's reported response rate and durability of responses
** FDA staff says the trial could not determine whether RP1, rather than nivolumab alone, drove the observed benefit
** In April, the health regulator declined to approve the drug for a second time, citing insufficient data from studies
** Up to last close, stock was down 11.2% YTD
(Reporting by Christy Santhosh)
Recent news on Replimune
See all newsTrump picks White House adviser Heidi Overton to run FDA, source says (updated)
Brief: Replimune Group, Inc. Files For Mixed Shelf Size Not Disclosed
Brief: Replimune Reports Fiscal First Quarter 2027 Financial Results And Provides Corporate Update
Replimune Q1 net loss narrows as expenses decline
U.S. STOCKS ON THE MOVE-Microsoft, Coastal Financial, Eli Lilly