Replimune Group, Inc. (REPL) announced on Tuesday that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application for RP1 in combination with Nivolumab to treat advanced melanoma. As a result of this announcement, Replimune's stock has surged, rising 26.09% to $12.78 on the Nasdaq market.
RP1 is engineered to enhance tumor-killing efficacy, boost the immune response triggered by tumor cell death, and stimulate a systemic anti-tumor immune response. The FDA's acceptance relies on the primary analysis data from the IGNYTE trial, which evaluated this combination therapy in adults whose melanoma had not responded to anti-PD-1 treatment.
Additionally, Replimune has been granted Breakthrough Therapy designation for the RP1-Nivolumab combination, underlining its potential to significantly improve the treatment of advanced melanoma.
