Vusolimogene oderparepvec

WOBURN, Mass., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the company completed a Type A meeting with the U.S. Food and Drug Administration (FDA) on September 16th to discuss the complete response letter (CRL) for the Company’s Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma. The company is evaluating the feedback from the FDA provided during the meeting to determine next steps. At this time, a path forward under the accelerated approval pathway has not been determined. “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.” About RP1RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response. About ReplimuneReplimune 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. Forward Looking StatementsThis press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about our cash runway, the content of our interactions with the FDA at our Type A Meeting, the outcome and timing of any resolutions following such meeting, the viability of the continuation of our confirmatory trial in advanced melanoma, and other statements identified by words such as “could,” “expects,” “intends,” “hope,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, if any, our ability to resolve the issues identified in the CRL and the Type A meeting in a manner satisfactory to the FDA and to us and the timing thereof, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of a global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements. Investor InquiriesChris BrinzeyICR Healthcare339.970.2843chris.brinzey@icrhealthcare.com Media InquiriesArleen GoldenbergReplimune917.548.1582 media@replimune.com

Replimune’s shares fell by more than 40% on Thursday after the Massachusetts-based company raised fresh questions about the path forward for its melanoma drug under the FDA’s accelerated approval pathway. The company $REPL said such a path for approval “has not been determined” after a follow-up meeting with the FDA to discuss its July rejection of the drug. Replimune’s treatment, called RP1, was tested in combination with Bristol Myers Squibb’s PD-1 inhibitor Opdivo for advanced melanoma. An accelerated approval seemed to be all but certain leading up to the July 22 decision date. The FDA hadn’t requested an advisory committee and the biotech said it was in label negotiations with the agency, and had already completed manufacturing and clinical trial site inspections — the usual final steps ahead of an approval. Replimune’s open-label trial tested 140 patients who had previously progressed on an anti-PD-1 drug. The trial saw an overall response rate, the study’s primary endpoint, of 32.9%. The three-year survival rate was 54.8%. PD-1s became the new standard of care in the first-line setting for advanced melanoma about a decade ago. Upon receiving a complete response letter, Replimune said the issues FDA raised hadn’t been part of its dialogue with the agency. According to the company, the FDA said the CRL was the result of the “heterogeneity” of the patient population in the pivotal trial, and the potential that Opdivo might be driving patients’ responses. But the idea that size of the effect could be from Opdivo alone “just doesn’t hold water,” Replimune’s founder and executive chairman Philip Astley-Sparke told Endpoints News in August.