Replimune Announces FDA Acceptance of RP1 Biologics License Application Resubmission for Advanced Melanoma (Form 8-K)

Replimune Announces FDA Acceptance of RP1 Biologics License Application Resubmission for Advanced Melanoma

FDA decision expected by August 2, 2026

WOBURN, Mass., June 26, 2026 (GLOBE NEWSWIRE) - Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. The FDA considers this a complete, class 1 response with a goal date of August 2, 2026, and has notified the company to expect an advisory committee meeting in late July.

"We are pleased that the FDA has demonstrated urgency in reconsidering the RP1 BLA with an expeditious action date in recognition of the significant unmet need for advanced melanoma patients and support from the broader melanoma community," said Sushil Patel, Ph.D., CEO of Replimune. "We look forward to a productive scientific and clinical discussion on the risk/benefit profile of RP1 in this difficult to treat setting."

The resubmission seeks accelerated approval of RP1 in advanced melanoma based on data from the IGNYTE clinical trial, which evaluated RP1 combined with nivolumab in patients with confirmed progression on an anti-PD-1 containing regimen.

About Advanced Melanoma

Melanoma is the fifth most common cancer in the United States, with approximately 112,000 new cases estimated in 2026 and the most lethal form of skin cancer, accounting for nearly 8,500 deaths annually. Melanoma is considered advanced when the cancer has spread beyond the primary tumor. Standard of care therapy includes immune checkpoint blockade, to which approximately half of patients will not respond or will progress after treatment, leaving a significant population in need of effective therapeutic alternatives.

About RP1

RP1 (vusolimogene oderparepvec) is Replimune's lead product candidate, based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R⁻) and GM-CSF. RP1 is designed to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, 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. The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to then activate a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.