FDA granted accelerated approval to Replimune’s oncolytic viral therapy Tudriqev for advanced melanoma, after the program previously faced twice-spurned FDA feedback. The approval followed a resubmission and a positive advisory committee vote within a four-month window. The regulator’s decision positions Tudriqev as a potentially more convenient option versus Iovance Biotherapeutics’ cell therapy, which had been the primary treatment in this setting. Replimune is effectively resetting the clinical and regulatory narrative for its platform as it moves into commercialization and follow-on evidence generation.