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Replimune RP1 BLA Resubmission Accepted by FDA; PDUFA Date Set for April 10, 2026 | FDA Rejects Replimune Skin Cancer Therapy RP1: What This Means for Patients | Replimune RP1 BLA Resubmission Accepted by FDA; PDUFA Date Set for April 10, 2026 | FDA Rejects Replimune Skin Cancer Therapy RP1: What This Means for Patients

News / FDA Approvals

Replimune RP1 BLA Resubmission Accepted by FDA; PDUFA Date Set for April 10, 2026

Replimune (NASDAQ: REPL) announced that the FDA has accepted the Biologics License Application (BLA) resubmission for RP1, in combination with nivolumab, for the treatment of advanced melanoma. The FDA has set a PDUFA target action date of...

PDUFA Apr 10, 2026: Replimune's BLA Resubmission for RP1 Accepted by FDA for Advanced Melanoma
Replimune RP1 BLA Resubmission Accepted by FDA; PDUFA Date Set for April 10, 2026 Image via Stock Titan
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News / FDA

FDA Rejects Replimune Skin Cancer Therapy RP1: What This Means for Patients

The FDA has rejected Replimune Group's RP1, a viral-based therapy intended for advanced skin cancer, due to inadequate trial data. This decision highlights the agency's increasingly stringent approach to new drug approvals and raises concer...

Replimune skin cancer therapy rejected by FDA