Replimune is axing 144 employees at its Woburn headquarters and 80 at its Framingham manufacturing site. The cuts follow the FDA’s second rejection of the biotech’s advanced melanoma candidate.
Replimune’s path forward following the FDA’s second rejection of advanced melanoma drug RP1 includes cuts affecting 224 employees in Massachusetts, according to Worker Adjustment and Retraining Notification Act (WARN) notices. Most of the layoffs are hitting the biotech’s Woburn headquarters.
The first cuts in Woburn involved 63 employees, with terminations effective April 13–24, according to a notice dated April 13. On April 17, two more WARN alerts outlined further layoffs: 81 people in Woburn and 80 at Replimune’s manufacturing facility in Framingham. The latest rounds of cuts are effective April 17–24.
Arleen Goldenberg, Replimune’s vice president of corporate communications, told Fierce Biotech the company will have 40% of its workforce left after the Massachusetts cuts are complete.
In the April 10 announcement regarding the FDA’s rejection of RP1, the biotech’s lead product candidate, Replimune CEO Sushil Patel said the agency’s decision left the business with no choice but to eliminate jobs, including substantially scaling back its U.S.-based manufacturing operations. BMO Capital Markets wrote in a note to investors that day that the company faced “a challenging path forward” and needed to secure funding, referencing its $269.1 million cash position as of Dec. 31.
Regarding the fate of RP1, Patel said in the announcement that without timely accelerated approval, development of the drug won’t be viable. He called the FDA’s decision “deeply disappointing,” while Replimune noted that the agency in 2021 had agreed that if the data proved sufficiently compelling, a single-arm trial would be acceptable for consideration under accelerated approval. The complete response letter (CRL), however, stated that such a study was not considered adequate nor well-controlled.
BMO analysts sided with the FDA, stating that the CRL made it clear that Replimune and the agency had not truly aligned on the use of a single-arm study nor on the biotech’s methods to assess the drug’s efficacy.
