Overview
- The FDA accepted Replimune’s resubmitted BLA for RP1 given with nivolumab and set April 10, 2026 as the decision date under a Class II review.
- Acceptance signals the filing is complete for review but does not constitute approval.
- Replimune shares roughly doubled on the news, with the stock trading near $9 by late Monday.
- Wedbush and Leerink upgraded the stock following the announcement, lifting price targets to $18 and $13, respectively.
- The application seeks use in advanced melanoma for patients who progressed on anti–PD-1 therapy, using the RP1 and Opdivo combination.