Vusolimogene oderparepvec

iStock, Yutthana Gaetgeaw Investors had been “holding out hope” that there remained a regulatory path forward for RP1, but results of Replimune’s Type A meeting with the FDA do not appear to support this, according to BMO Capital Markets. Replimune does not yet see a clear path forward for its investigational cancer therapy RP1—even after wrapping up a post-rejection meeting with the FDA. In a brief press announcement on Thursday, the Massachusetts-based biotech said that RP1’s path forward under the accelerated approval pathway “has not been determined.” Replimune met with the FDA on Sept. 16 for a Type A meeting to discuss the regulator’s complete response letter in July for RP1. Replimune closed Thursday’s trading session at $3.46, down nearly 40% from its ending price of $5.71 the previous day. Thursday’s news gives BMO Capital Markets “further pause and concern for the long-term viability of the RP1 program,” analysts wrote in a note to investors. Some shareholders had been “holding out hope,” they continued, for the possibility of restructuring the RP1 program or using the data already available to build toward future approval. “These hopes do not appear to be supported today,” BMO said. “The lack of reassurance at a time when investors need it most paints a bleak picture of the company’s future,” the analysts added. RP1, also named vusolimogene oderparepvec, uses an engineered HSV virus that targets cancer cells and replicates inside them, in turn making them more vulnerable to an immune response. Replimune backed its application with data from the Phase III IGNYTE trial, which demonstrated a 32.9% confirmed objective response rate , including a 15% complete response rate. The FDA’s rejection of RP1 in July came as a surprise to those who were following the drug, with BMO analysts at the time suggesting that new leadership at the FDA might have new expectations for data submitted to it. "[Center for Biologics Evaluation and Research head Vinay] Prasad has previously been critical of the approvability of uncontrolled data, and today we see that opinion underscored,” the analysts wrote. Indeed, the FDA’s complete response letter argued that IGNYTE was not an “adequate and well-controlled clinical investigation.” In a statement following the rejection, Replimune CEO Suhil Patel said he was “surprised” and “disappointed,” particularly given that the agency had not raised the issues enumerated in the rejection letter at prior meetings. “We had also aligned on the design of the confirmatory study,” Patel said at the time. The researchers behind IGNYTE, alongside other experts in the field, bristled at the rejection. Last month, a group of 22 scientists penned an open letter to the FDA, urging the agency to “re-review” RP1’s application. Among other contentions, the researchers argued in their letter that the heterogeneity of IGNYTE’s population, which the FDA had flagged as a methodological weakness, more accurately reflects RP1’s real-world patient population. “Multiple treatment pathways in both the adjuvant and advanced disease setting [funnel] to the point of IGNYTE eligibility,” they wrote.

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