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 Updates
** Shares of drug developer Replimune REPL.O fall 32% to $5.86
** 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
** FDA staff reviewers say results from a trial lacking a randomized control group could not establish whether longer survival was due to the treatment rather than patient selection or other factors
** 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
** Including session's move, stock was down 40% YTD
(Reporting by Christy Santhosh)
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