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FDA accepts Replimune RP1 BLA resubmission for advanced melanoma; PDUFA Aug 2
The FDA has accepted for review Replimune's resubmitted Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for advanced melanoma, classifying it as a complete Class 1 response with a target action date of August 2, 2026 and an advisory committee expected in late July. The resubmission seeks accelerated approval based on IGNYTE trial data in patients who progressed on anti‑PD‑1 therapy; the company did not disclose efficacy or safety numbers in this release, so near‑term market reaction will hinge on the advisory committee and FDA review.
Replimune to resubmit RP1 BLA after FDA agrees to prioritized review
Replimune said it will resubmit the BLA for RP1 (vusolimogene oderparepvec) plus nivolumab for advanced melanoma in the coming days after collaborative discussions with the FDA. The agency told the company it will treat the resubmission as urgent and prioritize review; the application is supported by IGNYTE trial data in patients who progressed on anti‑PD‑1 therapy, a population with limited treatment options.