Overview
- The FDA sent a Complete Response Letter refusing approval of RP1 with nivolumab for advanced melanoma, marking a second rejection of the filing.
- Regulators questioned the strength of the evidence and consistency of tumor assessments, raising issues with how responses were measured under RECIST 1.1 for RP1, an engineered herpes virus designed to attack tumors and spark immune responses.
- Replimune pointed to its single‑arm IGNYTE results showing a 34% response rate and a 24.8‑month median duration of response, arguing prior FDA feedback suggested this could support accelerated approval.
- The company said the FDA reassigned the review team during resubmission and declined meeting requests, while analysts downgraded the stock after the decision and shares fell about 64% to roughly $1.71.
- CEO Sushil Patel said the company will cut jobs and scale back U.S. manufacturing, and investors now question whether data from the ongoing IGNYTE‑3 trial will meet FDA expectations for a rigorous, controlled test.