Replimune Cancer Therapy Rejected Again, Layoffs Follow Replimune received second FDA CRL. Cancer therapy faced regulatory rejection. Company initiated multiple layoff rounds. Future viability now faces serious concerns. Replimune's unnamed cancer therapy received a second Complete Response Letter (CRL) from the FDA. This follows an initial CRL, signaling persistent regulatory hurdles. The therapy, in late-stage clinical trials, aimed to address a critical unmet need in oncology. The FDA's decision was likely triggered by unresolved manufacturing issues or insufficient efficacy data from the pivotal study. The FDA's repeated CRL indicates significant deficiencies, preventing drug approval under 21 CFR Part 314. This typically requires Replimune to resubmit a comprehensive response addressing all concerns. Without a clear path forward, the company faces a prolonged delay or potential abandonment of the asset. No EMA action for this specific drug is currently recorded in the BrunoSan database. This rejection severely impacts Replimune's market position and investor confidence. Competitors like Amgen and Merck, with established oncology pipelines, stand to benefit from Replimune's setback. The company's future hinges on its ability to address FDA concerns, with a critical board meeting scheduled for Q3 2026 to reassess strategy.