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.
Scientists have identified SLAMF6 as a key suppressor of T cell immunity against cancer and developed monoclonal antibodies that neutralize it in mice, published in Nature. Biotechnology company Replimune Group has reported its 2026 financial position, with a market value of approximately $234.5 million and ongoing clinical trials.
The FDA has approved Pfizer's BRAFTOVI for BRAF V600E metastatic colorectal cancer and VEPPANU for ESR1 mutated breast cancer. The oncolytic virus cancer therapy pipeline expands with over 120 companies developing 125+ drugs. Positive late-stage data for other Pfizer oncology programs was also reported.
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.
