Shares of drug developer Replimune REPL.O fall 6% to $12.10
Late Thursday, the U.S. FDA granted accelerated approval to Replimune's Tudriqev for advanced melanoma 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
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
Piper Sandler analyst Allison Bratzel says the lower ORR is also below rival Iovance's IOVA.O Amtagvi's labeled 31.5% ORR, but doesn't view it as "a huge deal"
Replimune told investors on a conference call that it does not expect the label language to affect adoption of the therapy
Shares are more than 7x above the 52-week low of $1.50 in April 2026
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