Replimune is reducing its workforce by 224 employees across its Massachusetts operations following the U.S. Food and Drug Administration’s (FDA) second rejection of its advanced melanoma candidate, RP1. The layoffs include 144 roles at the company’s Woburn headquarters and 80 positions at its manufacturing facility in Framingham, according to Worker Adjustment and Retraining Notification (WARN) notices.
The job reductions were carried out in multiple stages during April. An initial notice dated April 13 outlined layoffs affecting 63 employees in Woburn, with terminations scheduled between April 13 and April 24. Additional WARN notices issued on April 17 detailed further reductions, including 81 employees in Woburn and 80 at the Framingham manufacturing site. These later terminations were also set to occur between April 17 and April 24.
Arleen Goldenberg, Replimune’s vice president of corporate communications, stated that after the Massachusetts layoffs are completed, the company will have 40% of its workforce remaining. She also said the layoffs affect roles across the company, including its manufacturing operations, and described them as a direct result of the FDA’s action.
The workforce reductions follow the FDA’s issuance of a complete response letter (CRL) rejecting RP1, also known as vusolimogene oderparepvec, for the second time. The agency had previously rejected the treatment in July 2025. Replimune resubmitted the application in October with additional data, but the FDA again concluded that the study did not meet the standard of an “adequate and well-controlled” trial. Reviewers from the Office of Therapeutic Products and the Oncology Center of Excellence stated that the data presented were insufficient to establish substantial evidence of effectiveness.
Replimune had indicated that in 2021, the FDA agreed that a single-arm trial could be considered for accelerated approval if the data were sufficiently compelling. However, the CRL stated that the study design used was not considered adequate or well-controlled. Analysts from BMO Capital Markets wrote that the response letter showed that the company and the FDA were not aligned on the use of a single-arm study or on how the drug’s efficacy was assessed. The firm also referenced Replimune’s $269.1 million cash position as of December 31 and noted that the company needed to secure funding.
In an April 10 announcement, Replimune CEO Sushil Patel said the FDA’s decision left the company with no choice but to eliminate jobs and substantially scale back its U.S.-based manufacturing operations. He also stated that without timely accelerated approval, development of RP1 would not be viable.
Replimune disagreed with the FDA’s assessment. Patel said, “It is deeply disappointing that the FDA has not exercised regulatory flexibility to meet patients’ needs given the data supporting strong efficacy and the favorable safety profile.”
Despite the layoffs and regulatory setbacks, the company stated that it is continuing its operations. Goldenberg noted that Replimune has another candidate, RP2, currently in a phase 2/3 trial for metastatic uveal melanoma and in a phase 2 study for hepatocellular carcinoma.
Details Behind Replimune Job Cuts
The layoffs will impact approximately 224 employees in Massachusetts, representing a substantial portion of Replimune workforce. The move reflects how Replimune is restructuring operations to conserve resources and focus on priority programs amid ongoing uncertainty around RP1.
The repeated rejection raises questions about the robustness of the clinical data submitted for RP1. Regulatory authorities typically require clear evidence of both safety and efficacy, and any gaps in trial design, endpoints, or statistical significance can lead to delays or denials. Addressing these concerns often requires additional studies, which can be both time-consuming and costly.
Financial Pressure on Biotech Firms
Setbacks like this can place significant financial strain on mid-stage biotech companies. Without near-term product approvals, firms may struggle to maintain investor confidence and secure additional funding. Cost-cutting measures, including workforce reductions, are often implemented to extend cash runway and maintain operational stability.
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