Replimune Group Inc. (NASDAQ: REPL) announced it will resubmit its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma treatment following discussions with the U.S. Food and Drug Administration.

The Woburn, Massachusetts-based biotechnology company said the FDA indicated it would treat the BLA resubmission as urgent and prioritize its review. The resubmission will occur in the coming days, according to a company statement.

RP1, also known as vusolimogene oderparepvec, is an oncolytic immunotherapy based on a genetically engineered herpes simplex virus. The treatment is designed for patients with advanced melanoma who have progressed on prior anti-PD-1 based therapy.

"We are grateful to the FDA leadership for their willingness to engage in a collaborative dialogue towards finding a meaningful path forward for RP1," said Sushil Patel, Chief Executive Officer of Replimune.

The application is supported by data from the IGNYTE clinical trial, which evaluated RP1 combined with nivolumab in patients with confirmed progression on an anti-PD-1 containing regimen. The company stated that standard checkpoint inhibitor therapy fails approximately half of patients who receive it.

According to the company, approximately 8,500 Americans with advanced melanoma die each year, with an estimated 112,000 new melanoma cases expected in 2026. Melanoma is considered advanced when the cancer has spread beyond the primary tumor.

RP1 is engineered with a fusogenic protein and GM-CSF, designed to maximize tumor killing and activate systemic anti-tumor immune response. Replimune was founded in 2015 and focuses on developing oncolytic immunotherapies.