Replimune slides as FDA approval label tempers enthusiasm
BUZZ-Replimune slides as FDA approval label tempers enthusiasm ** Shares of drug developer Replimune REPL.O fall 5% to $12.21 premarket
** Late Thursday, the U.S. FDA granted accelerated approval to Replimune's drug Tudriqev for advanced melanoma in patients whose tumors grew despite prior treatment
** Wedbush analyst Robert Driscoll says the stock's weakness is likely tied to the FDA-approved label citing a 24% objective response rate, ORR, below the 33% figure highlighted previously
** ORR measures the percentage of patients whose tumors shrink or disappear after treatment
** The lower ORR reflects data from patients with at least one non-injected target lesion, Driscoll says
** Replimune told investors on a conference call that it does not expect the label language to affect adoption of the therapy
** Co says an average course of Tudriqev will cost about $450,000, with shipments expected to begin in roughly 60 days
** As of last close, stock up 32.3% YTD
(Reporting by Kamal Choudhury in Bengaluru)
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