Replimune expects to complete the layoffs by Friday.
Woburn-based drug developer Replimune is set to lay off 80 employees at its Framingham manufacturing facility after the U.S. Food and Drug Administration rejected its cancer treatment.
Replimune expects to complete the layoffs by Friday at its facility at 33 New York Ave. in Framingham, according to a Worker Adjustment and Retraining Notification Act notice filed with the state.
The Framingham terminations are part of a companywide workforce reduction. Replimune expects to lay off 144 workers at its Woburn headquarters, according to WARN filings.
Replimune employed 479 workers as of March 31, 2025, according to its annual report filed on May 22 with the U.S. Securities and Exchange Commission.
The layoffs are directly tied to Replimune, a clinical-stage company, receiving a second rejection of its lead cancer-fighting drug, RP1, used to treat advanced melanoma, said Arleen Goldenberg, Replimune's vice president of corporate communications.
The FDA said the clinical trial data provided by Replimune was not sufficient enough to bring the drug to market. Replimune's CEO Sushil Patel said in an April 10 announcement that without accelerated approval, the development of RP1 will not be viable.
“Unfortunately, for patients and physicians in the melanoma community, we have had no choice but to stop our compassionate use program and adjust the planned expansion of our Phase 3 clinical trial program,” Goldenberg said in the email.
This decision puts not only the company’s RP1 therapy at risk, but its RP2 drug and the entire company at risk, she said.
Mica Kanner-Mascolo is a staff writer at Worcester Business Journal, who primarily covers the healthcare, manufacturing, and higher education industries.