Business

Woburn biotech cuts more than 200 jobs after FDA setback

The layoffs follow the agency’s decision not to approve the company’s advanced melanoma treatment.

April 22, 2026 | 1:58 PM

1 minute to read

Replimune is cutting 223 jobs across its headquarters in Woburn and manufacturing facility in Framingham after the FDA failed to approve its latest treatment for advanced melanoma earlier this month.

According to the company, the first round of layoffs was announced on April 10, affecting 63 positions at its commercial organization. A subsequent round of layoffs occurred last Friday, affecting another 160 employees at the U.S. headquarters in Woburn and at the Framingham manufacturing facility.

As of March 31, 2025, the company, in its annual report, said it employed 479 people, meaning it is laying off about half of its workforce.

“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 program,” the company said in a statement.

It continued, “This decision has not only put much-needed therapies at risk, including RP1 and RP2, but it has also put the company at risk.”

RP1 and RP2 are experimental cancer treatments that use a modified virus to help the body fight tumors. In declining to approve RP1 treatments, the FDA cited “insufficient data to prove efficacy.”

In a statement following the FDA’s decision not to move forward with the RP1 treatment, the company said that about 8,500 Americans with advanced melanoma die every year.

Melanoma is the fifth most common cancer, with about 112,000 new cases estimated in the U.S. in 2026, and it is the most lethal form of skin cancer. Melanoma becomes advanced when it spreads beyond the primary tumor to other parts of the body.

“Patients and caregivers pleaded for urgency,” said Sushil Patel, Ph.D., CEO of Replimune, in a statement. “All of it was met with inconsistent communication and a fragmented and slow-moving regulatory process, which clearly puts U.S. innovations at risk.”

A group of industry experts in oncolytic immunotherapy founded Replimune in 2015 to create the next generation of cancer treatments.