Replimune's BLA For RP1-Nivolumab Combo Gets FDA Approval For Advanced Melanoma, Stock Surges

(RTTNews) - Replimune Group, Inc. (REPL), Tuesday announced that the U.S. Food and Drug Administration has accepted the Biologics License Application for RP1 in combination with Nivolumab for the treatment of advanced melanoma.

Following the announcement, Replimune's stock is currently climbing 26.09 percent, to $12.78 on the Nasdaq.

Replimune said RP1 is intended to maximize tumor-killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

The acceptance is based on the primary analysis data of the IGNYTE trial, investigating the combined therapy in adults with anti-PD-1 failed melanoma.

Replimune had received Breakthrough Therapy designation for RP1 in combination with nivolumab for the treatment of advanced melanoma.