Replimune tumbles after FDA declines to approve melanoma drug

Bristol-Myers Squibb Co

10/04/2026 23:13

** Shares of biotech firm Replimune REPL.O fall 59% to $1.98 in extended trading

** FDA says it declined to approve REPL's experimental treatment for advanced melanoma, a serious form of skin cancer

** FDA says data from the two studies were not strong enough to support approval of the treatment in combination with Bristol Myers Squibb's BMY.N Opdivo

** Regulator says the filing relied mainly on a single-arm study, making it hard to isolate the drug's benefit when used in combination

** CEO Sushil Patel says co has no choice but to eliminate jobs and substantially scale back its U.S.-based manufacturing operations

** Trading in REPL shares was halted ahead of the announcement on Friday

** Stock down ~51% YTD

(Reporting by Sahil Pandey and Christy Santhosh in Bengaluru)

((Sahil.Pandey@thomsonreuters.com))