Replimune is saying goodbye to a further 161 employees across two Massachusetts sites as the company continues to reel from another FDA rejection for its lead melanoma candidate.
The latest layoffs, affecting 81 employees in Woburn and 80 employees in Framingham, are “a direct result of the FDA action,” Arleen Goldenberg, Replimune’s vice president of corporate communications, told Fierce Biotech. The roles are spread across the entire company, including Replimune’s manufacturing operation.
They follow the loss of 63 roles—which were focused on the biotech’s commercial organization—announced the same day that the FDA published its rejection letter of Replimmune’s melanoma drug RP1.
All told, Replimune will be left with just 40% of its employees remaining after the two layoff rounds have been completed, Goldenberg said. But even with its workforce winnowed down by 60%, Replimune is not throwing in the towel.
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“At this time, the company is continuing its operations,” Goldenberg said, noting that Replimmune has another candidate, RP2, in a phase 2/3 trial for metastatic uveal melanoma and a phase 2 study for hepatocellular carcinoma.
The FDA initially rejected RP1, an oncolytic virus also known as vusolimogene oderparepvec, in July 2025. The biotech enjoyed a stock boost after submitting RP1 for approval again in October along with some additional data. But the second time was not the charm, and the agency remained unconvinced that Replimune had run an “adequate and well-controlled” trial.
Reviewers from the FDA’s Office of Therapeutic Products and Oncology Center of Excellence “unanimously determined data presented are insufficient to conclude substantial evidence of effectiveness,” the agency wrote in its letter.
Replimune disagreed with this assessment in an April 10 release, with CEO Sushil Patel, Ph.D., accusing the FDA of “inconsistent communication and a fragmented and slow-moving regulatory process.”
“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,” Patel said in an April 10 statement. “A treatment desperately needed by patients will not be available. Not because the medicine failed. Because the system did.”
