The FDA granted Replimune Group Inc. accelerated approval for its oncolytic immunotherapy, TUDRIQEV. The drug treats patients with advanced cutaneous melanoma that progressed despite anti-PD-1 therapies.
This approval transitions Replimune into a commercial-stage company. The decision validates the proprietary RPx platform, which uses an engineered herpes simplex virus to stimulate anti-tumor immune responses.
The launch of TUDRIQEV establishes a new revenue stream for the company. Replimune reported a net loss of $69.8 million for the quarter ending June 30, 2026.