WOBURN, Mass. — September 18, 2025 — Leads & Copy — Replimune Group, Inc. (NASDAQ: REPL) announced the completion of a Type A meeting with the U.S. Food and Drug Administration (FDA) on September 16th regarding the complete response letter (CRL) for its Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma.
The company is evaluating feedback from the FDA to determine its next steps. A path forward under the accelerated approval pathway has not been determined at this time.
“The feedback from the melanoma community, including patients and physicians, clearly highlights the unmet need in advanced melanoma and the compelling risk-benefit profile of RP1 observed in the IGNYTE trial,” said Sushil Patel, Ph.D., CEO of Replimune. “We remain committed to working with the FDA to determine an expeditious path forward for RP1.”
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate, engineered with a fusogenic protein (GALV-GP R-) and GM-CSF to maximize tumor killing potency, immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.
Replimune Group, Inc. was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response.
Investor Inquiries:
Chris Brinzey
ICR Healthcare
339.970.2843
chris.brinzey@icrhealthcare.com
Media Inquiries:
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com
Source: Replimune Group, Inc.
