Replimune slips as FDA accepts skin cancer drug review, but advisory panel adds risk

Bristol-Myers Squibb Co

26/06/2026 14:17

** Shares of Replimune REPL.O fall 4.7% to $10.61 premarket
** Replimune says the U.S. FDA has accepted co's resubmitted application to review its cancer drug for advanced skin cancer
** Replimune is seeking approval for vusolimogene oderparepvec, also known as RP1, in combination with Bristol Myers Squibb's BMY.N immunotherapy Opdivo for the treatment of advanced melanoma
** "The FDA considers this a complete, class 1 response with a goal date of August 2, 2026, and has notified the company to expect an advisory committee meeting in late July," co says
** Advisory committee meetings "always bring risk to approval," said Wedbush analyst Robert Driscoll, adding that the data should hold up to scrutiny and that the relatively quick turnaround is positive overall for Replimune 
** Last month, co said it would submit the drug for approval a third time and that the FDA would treat the resubmission as an urgent matter and prioritize its review
** In April, the health regulator declined to approve the drug for a second time, citing insufficient data from studies
** As of last close, stock up 14.5% YTD

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