APR 10 2026
Replimune Group — RP1 $REPL
for advanced melanoma after prior anti-PD-1 therapy
FDA issued a Complete Response Letter on the RP1 BLA resubmission, citing trial-design concerns. Stock fell ~75% on the news.
About
Melanoma is an aggressive form of skin cancer that can spread rapidly to other organs when untreated. RP1 is a genetically modified cold sore virus (HSV-1) designed to infect and kill cancer cells while also releasing immune-stimulating proteins (GM-CSF and GALV-GP-R-) to alert the body's defenses. This dual attack could help the immune system recognize and fight melanoma that has stopped responding to standard immunotherapies.
Pivotal trial
This is a randomized, controlled, multicenter, open-label Phase 3 clinical study comparing VO in combination with nivolumab versus Physician's Choice treatment for patients with unresectable Stage IIIb-IV cutaneous melanoma whose disease progressed on an anti PD-1 and an anti-CTLA-4 containing regimen (administered either as a combination regimen or in sequence) or who are not candidates for treatment with an anti-CTLA-4 therapy.
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on RP1
- Indonesia aims to boost returns from Rp1.2 trillion jamu industry - ANTARA News
- Replimune Group (REPL) Is Up 77.0% After FDA Prioritizes RP1 Melanoma BLA Resubmission Path - Has The Bull Case Changed? - simplywall.st
- Replimune plans RP1 BLA resubmission - The Pharma Letter
- US FDA Consistency Questions Remain As Replimune Eyes Third Shot At RP1 Approval - Citeline News & Insights
- RP1/Nivolumab Shows OS Benefit in Anti-PD-1-Progressed Melanoma - CancerNetwork