Also known as: Replimune
Replimune is a clinical-stage biotechnology company developing and commercializing oncolytic immunotherapies for cancer. Its pipeline includes RP1, RP2, and RP3 candidates designed to activate anti-tumor immune responses.
Replimune said the FDA issued a complete response letter for its RP1 plus nivolumab application in advanced melanoma. The company disputed the agency’s assessment and said it will cut jobs and scale back U.S. manufacturing.
The FDA accepted Replimune’s BLA resubmission for RP1 plus nivolumab in advanced melanoma. The agency set an April 10, 2026 PDUFA date under a Class II resubmission timeline.
Replimune Group Inc. approaches a critical regulatory milestone as the FDA is scheduled to decide on its RP1 melanoma therapy by April 10, 2026, with cash reserves extending into early 2027.
