Replimune Shares Soar 80% After FDA Agrees to Prioritize RP1 BLA
REPL•Replimune shares jumped 80% after the FDA agreed to prioritize review of its resubmitted BLA for RP1 combo with nivolumab to treat advanced melanoma. The agreement follows two prior rejections and a leadership shake-up at the FDA with head Marty Makary stepping down, and Replimune plans to resubmit the application.
1. FDA Agreement Secured and Review Prioritized
Replimune reached an agreement with the FDA to resubmit its BLA for RP1 in combination with nivolumab to treat advanced melanoma. The regulator will treat the resubmission as urgent and prioritize its review under an accelerated timeline.
2. Prior Rejections and Operational Impact
The application faced two Complete Response Letters in July 2025 and April 2026, prompting CEO Sushil Patel to criticize inconsistent review processes and warn of potential job cuts and scaled-back U.S. manufacturing following the second rejection.
3. Leadership Shake-Up and Next Steps
Agency head Marty Makary stepped down earlier this month, intensifying industry concerns over unpredictable approvals. Replimune plans to resubmit the application in the coming days, with traders expecting this path forward to accelerate the therapy’s regulatory timeline.
