$REPLJun 26, 2026, 12:01 PMAI processed
FDA accepts Replimune RP1 BLA resubmission for advanced melanoma; PDUFA Aug 2
AI Summary
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.
Positives
- FDA accepted the BLA resubmission as a complete Class 1 response
- Regulatory goal/PDUFA date set for August 2, 2026
- Advisory committee is expected in late July and the filing seeks accelerated approval based on IGNYTE trial in patients with progression on anti‑PD‑1 therapy
Negatives
- Acceptance for review is not an approval and regulatory risk remains
- Press release provides no efficacy or safety data to gauge likelihood of approval
- Advisory committee meeting introduces additional timing and review uncertainty