Overview

• The FDA’s Complete Response Letter said RP1’s IGNYTE trial was not an adequate and well-controlled study due to an overly heterogeneous patient population and design issues.
• The FDA noted no safety concerns for RP1, preserving the therapy’s potential if Replimune can resolve its efficacy questions.
• Replimune’s shares plunged roughly 75% to about $3 following the FDA’s rejection, underscoring investor uncertainty about RP1’s development path.
• Replimune plans to request a Type A meeting with the FDA within 30 days to discuss trial modifications and pursue an accelerated approval pathway for RP1.
• RP1 uses an engineered herpes simplex virus to attack tumors and stimulate immunity, achieving a 32.9% response rate in anti–PD-1–refractory melanoma, and sits atop a pipeline that includes second-generation candidate RP2.