Breakthrough Therapy Designation and Priority Review for RP1
RP1 has been recognized as a breakthrough therapy with priority review, with a PDUFA date set for July 22, 2025. The company has completed late-cycle meetings and manufacturing inspections with the FDA, indicating substantial regulatory progress.
Strong Commercial Readiness for RP1 Launch
Replimune has completed the build-out of its commercial infrastructure, including a customer-facing team of approximately 60 people, a patient support hub, and a distribution model ready for next-day delivery.
Financial Stability and Cash Position
The company ended the fiscal year with $483.8 million in cash and cash equivalents, providing a cash runway into the fourth quarter of 2026, supporting commercial launch plans and ongoing operations.
Potential for Broad and Rapid Adoption of RP1
Significant interest from medical oncologists and interventional radiologists, with over 90% willing to utilize RP1 routinely upon approval, suggests strong market potential for RP1 in advanced melanoma.