FDA rejected Replimune’s RP1 for advanced melanoma a second time, and 224 Massachusetts employees are now paying for it. WARN notices filed this month show most of the cuts hitting Woburn headquarters, with 80 more positions eliminated at the Framingham manufacturing facility.
The layoffs hit in three waves. Sixty-three Woburn employees got termination notices effective April 13–24. On April 17, two more WARN alerts covered 81 in Woburn and 80 in Framingham, effective that same week. When it’s all done, just 40% of Replimune’s workforce will remain, VP of corporate communications Arleen Goldenberg confirmed.
CEO Sushil Patel called the FDA’s decision “deeply disappointing” and said it left the company no choice but to eliminate jobs and scale back U.S. manufacturing. In 2021, FDA had acknowledged that a single-arm trial would be acceptable for accelerated approval consideration if data proved sufficiently compelling. The CRL reversed that, stating the study wasn’t adequate nor well-controlled. BMO Capital Markets analysts sided with FDA, writing that Replimune and the agency hadn’t truly aligned on study design or efficacy measurement.
Without timely accelerated approval, Patel said, RP1’s development isn’t viable. BMO noted the company held $269.1 million in cash as of December 31 but flagged a “challenging path forward” and the need to secure additional funding.
Remaining WARN-covered terminations are effective April 17–24.
Sarah Chen