RP1 (vusolimogene oderparepvec) and OPDIVO (nivolumab) - (IGNYTE-3)

June 29, 2026: Replimune Group, Inc. (NASDAQ: REPL) reported fiscal Q4 and full-year (ended March 31, 2026) results and provided a business update, highlighting regulatory and clinical catalysts for its oncolytic immunotherapy programs.

RP1 (vusolimogene oderparepvec) + nivolumab (advanced melanoma): The FDA accepted for review Replimune’s BLA resubmission, deemed a complete Class 1 response, with a goal date of August 2, 2026; the agency also notified the company to expect an advisory committee meeting in late July 2026. At ASCO 2026, an IGNYTE trial 3-year overall survival analysis in anti–PD-1-failed melanoma showed 47.8% alive at 3 years and median OS of 32.9 months, including 83.5% 3-year survival among responders. The Phase 3 IGNYTE-3 confirmatory trial (RP1+nivolumab vs physician’s choice) is actively enrolling; primary endpoint is OS.

RP2 (solid tumors / metastatic uveal melanoma): ASCO 2026 final Phase 1 data showed a 19% objective response rate for RP2 monotherapy and RP2+nivolumab, with durable responses (median duration not reached for monotherapy). The registration-directed Phase 2/3 REVEAL trial in metastatic uveal melanoma (RP2+nivolumab vs ipilimumab+nivolumab; ~280 patients) is enrolling; Phase 2/3 transition is expected in Q1 2027.

Financials: Cash/cash equivalents/short-term investments were $268.9M (March 31, 2026); company expects funding into calendar Q1 2027. Net loss was $73.7M (Q4) and $313.9M (FY).