Immuno-Oncology Drug Receives FDA Resubmission Acceptance…Decision Expected by August Next Year

Nasdaq-listed biotech Replimune Group, Inc. (NASDAQ: REPL) has officially begun the U.S. Food and Drug Administration’s formal review of its resubmitted Biologics License Application (BLA) for RP1, an advanced melanoma candidate being tested in combination with nivolumab. The FDA has classified the resubmission as a Class 1 complete response and set the PDUFA target date for August 2, 2026. An advisory committee meeting to review the benefit–risk profile is scheduled for late July.

In its fiscal 2026 fourth-quarter and full-year results, Replimune reported smooth enrollment in the RP1 confirmatory Phase 3 IGNYTE-3 trial and in the RP2 Phase 2/3 REVEAL trial in metastatic uveal melanoma. As of March 31, 2026, the company held $268.9 million (approximately KRW 350 billion) in cash and short-term investments and recorded a net loss of $313.9 million (approximately KRW 410 billion) for the year. Management said the current cash position is expected to fund operations into the first quarter of 2027.

At the American Society of Clinical Oncology (ASCO) 2026 meeting in May, Replimune presented final safety and efficacy data from the initial RP2 first-in-human solid tumor trial, demonstrating meaningful response rates and durability in uveal melanoma and other indications. Based on these results, the company is advancing the Phase 2/3 REVEAL trial combining RP2 with nivolumab in metastatic uveal melanoma. In April, it received a second Complete Response Letter (CRL) for the RP1 BLA, submitted additional data, and consequently secured acceptance of its resubmission for FDA reevaluation.

Replimune is a clinical-stage biotech developing next-generation oncolytic immunotherapies using genetically engineered herpes simplex virus to selectively destroy tumor cells and induce systemic immune responses. Oncolytic virus therapies are emerging as a promising option for treatment-refractory solid tumors with limited responses to checkpoint inhibitors, although they require significant time and investment to complete large-scale Phase 3 trials and satisfy stringent manufacturing and quality standards.