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, or 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
Company says label should not affect adoption
Replimune told investors on a conference call that it does not expect the label language to affect adoption of the therapy
The company said an average course of Tudriqev will cost about $450,000, with shipments expected to begin in roughly 60 days
As of last close, the stock was up 32.3% year to date
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