Replimune

Replimune Group, Inc. filed a WARN notice saying it will lay off 63 employees at its Woburn location, with the cuts scheduled to occur between April 13 and April 24. The layoffs follow the FDA's April 10 complete response letter rejecting Replimune's biologics license application for its lead investigational cancer therapy RP1 (vusolimogene oderparepvec), the company's second regulatory rejection after a July 2025 refusal. CEO Sushil Patel said the company must eliminate jobs and substantially scale back U.S.-based manufacturing operations, and Replimune is exploring strategic alternatives. The WARN filing lists Woburn as the affected site and it is unclear whether additional layoffs beyond the 63 are planned.

Company, a biotech firm based in Woburn, is set to lay off more than 200 employees following a second rejection from the FDA regarding its skin cancer treatment. The decision comes as the company faces significant challenges in bringing its product to market, which has led to a reevaluation of its workforce needs. The layoffs are a direct response to the setbacks in regulatory approval and are part of a broader strategy to streamline operations. This move underscores the difficulties faced by biotech companies in navigating the complex landscape of drug approval processes.