Replimune slides as FDA approval label tempers enthusiasm

Iovance Biotherapeutics

07/08/2026 18:14

Updates
** 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
** As of last close, stock up 32.3% YTD

 (Reporting by Kamal Choudhury in Bengaluru)
 ((Kamal.Choudhury@thomsonreuters.com;))