Replimune to resubmit melanoma therapy RP1 to FDA after two prior rejections

Replimune announced on Friday that it will again submit its advanced melanoma candidate, RP1, to the U.S. Food and Drug Administration for review. The company says the filing follows new discussions with the agency.

RP1 has previously been rejected twice by the FDA, but Replimune believes the latest data and dialogue address the concerns that led to those decisions. The company hopes the re‑submission will move the therapy closer to potential approval.

The move underscores Replimune's continued focus on developing immuno‑oncology treatments despite regulatory setbacks, and it will be closely watched by investors and industry observers.