Replimune’s Pivotal Year: All Eyes on 2026 FDA Decision

For Replimune and its investors, 2026 is shaping up to be a defining period. After a significant regulatory setback in mid-2025, the company’s prospects are now revitalized, centered on a crucial upcoming decision from the U.S. Food and Drug Administration. The potential approval of its lead candidate, RP1 for advanced melanoma, alongside compelling new clinical data, could mark a dramatic turnaround for the biotech firm.

A major positive development occurred on October 20, 2025, when the FDA accepted the company’s resubmitted Biologics License Application (BLA) for RP1. This action represents a critical reversal of fortune following a Complete Response Letter the agency issued in July of the same year. The regulator has assigned Read more...