Replimune falls more than 70% as US FDA declines to approve skin cancer drug

Iovance Biotherapeutics

22/07/2025 15:00

Updates

** Shares of drug developer Replimune Group REPL.O fall 75.3% to $3.05

** Co says the U.S. FDA declined to approve its experimental skin cancer drug, RP1, for patients with advanced melanoma

** FDA in its complete response letter said the clinical trial "was not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness"

** FDA said trial cannot be adequately interpreted due to the heterogeneity of the patient population - REPL

** Co plans to urgently interact with FDA to find a path forward

** Co was testing RP1 in combination with Bristol Myers Squibb's BMY.N Opdivo in patients with advanced skin cancer

** Shares of rival Iovance IOVA.O rise 11.9% to $2.79; Jefferies says FDA's rejection of REPL's drug "was technically not an overhang to IOVA stock per se, the situation does mean one less competitor in the nearer term"

** Including session moves, REPL down 76% YTD

 (Reporting by Sneha S K)

 ((Sneha.SK@thomsonreuters.com))