Replimune announced on Aug. 7 that it has received approval from the Food and Drug Administration for Tudriqev, its therapy for advanced melanoma, following a challenging regulatory process marked by two prior rejections. The company is now preparing to launch the treatment commercially, shifting its focus from regulatory hurdles to market execution.
“We are incredibly grateful to those internally and externally who fought so hard for patient access to this innovative and important therapy,” CEO Sushil Patel said during a Thursday afternoon conference call.
BMO Capital Markets projects $1.3 billion in peak revenue for Tudriqev by 2035, citing the broad label granted by the FDA with few restrictions. Replimune will be entering the PD-1-refractory melanoma market, where limited options exist, and BMO expects Tudriqev to become a preferred treatment option. “We expect Tudriqev to eventually command a meaningful share in the U.S. refractory melanoma market, shifting the REPL story from binary approval risk toward commercial execution,” BMO wrote in a Friday morning note.
The FDA's decision followed an advisory committee meeting at the end of July that ultimately supported approval of Tudriqev despite some reservations among committee members. The agency had previously described data from Replimune’s Phase 1/2 IGNYTE clinical trial as “not interpretable.” Patel addressed concerns about whether issues raised during this process would affect future studies or product launch plans: “One of the benefits of the adcomm was just the tremendous public and physician support and awareness it’s created for RP1,” he said. “When you listen to the open public forum, it was very clear that this is a treatment that patients very much need and physicians want.”
Patel also said he does not believe concerns about response criteria in earlier trials will impact ongoing confirmatory Phase 3 research: “The response criteria and assessment really has no impact on whether the patient ultimately lives longer or not,” Patel explained. Chief Medical Officer Kostas Xynos said enrollment is underway with about one-third completed; topline data are expected in 2030.
Replimune plans an initial rollout targeting 200 early adopter accounts within six months, expanding further over time as part of what Patel called a slow and steady launch strategy. The company aims to begin shipping product within approximately two months at an average round cost of $450,000 per patient—though actual costs may vary depending on tumor burden and number of treatments required.
