Replimune, a Woburn, Massachusetts-based biotech developing oncolytic immunotherapies, announced on April 21, 2026 that it would cut 161 employees, roughly 60% of its workforce, across its two Massachusetts sites. The cuts include 81 positions at its Woburn headquarters and 80 at its Framingham manufacturing facility. These layoffs come on top of 63 jobs already cut on April 13, bringing total reductions above 200 employees in a single month.
The trigger was a second rejection by the FDA of the company's lead melanoma drug candidate, RP1. The FDA's complete response letter, dated April 10, stated that reviewers had "unanimously determined data presented are insufficient to conclude substantial evidence of effectiveness." CEO Sushil Patel said in a statement that without timely accelerated approval, continued development of RP1 "will not be viable." After the cuts, Replimune will have approximately 40% of its original workforce.
Replimune is one of several clinical-stage biotechs that have been forced into dramatic restructurings in 2026 after FDA setbacks on lead candidates. Bicycle Therapeutics cut 30% in March after a similar accelerated-approval rebuff for a bladder cancer drug. Gossamer Bio cut 48% after a Phase 3 failure. Disc Medicine cut 20% after its own FDA rebuff in February. The pattern is the same each time: one regulatory setback removes the pipeline's near-term commercial path and the company has no choice but to slash headcount and retrench.
For Massachusetts, Replimune's Woburn and Framingham cuts are a blow to a regional biotech cluster already contending with Takeda's 634-job restructuring and Vertex's Mass-based functional reorganization. The Boston Globe noted that the biotech industry's relationship with the FDA under RFK Jr.'s HHS has grown increasingly uncertain, with shifting approval standards complicating already-risky clinical development bets.