TUDRIQEV approved after two CRLs, now commercial — survival depends on IGNYTE-3 confirming benefit

Replimune is a commercial-stage company with an approved oncolytic virus therapy combined with an immunotherapy drug for melanoma, though the approval is conditional and depends on an ongoing confirmatory trial demonstrating a survival benefit.

TUDRIQEV (vusolimogene oderparepvec-wtpg plus nivolumab) reached accelerated approval in August 2026 after two Complete Response Letters, an FDA adcom vote overriding staff concerns, and a 24.2% ORR on single-arm data. The confirmatory burden now defines the investment: if IGNYTE-3 verifies overall survival benefit, the approval converts to full; if it fails, withdrawal risk is real. Cash of $195M post-financing supports roughly one year of operations at current burn, making the runway tight relative to a 2030 OS readout.