Replimune Group reports 2024 EPS ($3.24), consensus ($3.27)

“We have exciting milestones in the coming months, including sharing the investigator-assessed 12-month IGNYTE data at ASCO and then the official primary analysis by independent central review later in the second quarter,” said Sushil Patel, Ph.D., CEO of Replimune. “Importantly, the design of our Phase 3 confirmatory IGNYTE-3 clinical trial has been agreed with the FDA, with patient enrollment planned to initiate in the second half of the year prior to the submission of our BLA for RP1. We also completed a successful Type C meeting with the FDA to align on our CMC plans ahead of the intended BLA. These are all critical steps as we plan for our next phase as a commercial stage company and, pending FDA approval, prepare to bring our first oncolytic immunotherapy to patients with advanced skin cancer.”