-- Replimune Group's (REPL) biologics license application for vusolimogene oderparepvec was rejected by the US Food and Drug Administration, the regulator said in a complete response letter on Friday.
The application was for vusolimogene oderparepvec plus nivolumab to treat adults with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 blocking antibody-based therapy, the letter said.
The regulator and experts unanimously decided that the data presented in the application were "insufficient" to show that the treatment is effective for advanced melanoma, the letter added.
Shares of Replimune Group were down 19.5% before being halted on Nasdaq at about 11:02 a.m. ET.
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