Breakthrough Therapy Designation
RP1 received Breakthrough Therapy Designation with priority review from the FDA, with a PDUFA date set for July 22, 2025.
Strong Clinical Data for RP1
Data from the Ignite Study shows that roughly one-third of patients achieve durable response in a high unmet need setting, with a median duration of response over 20 months and more than 55% of patients alive at 3 years.
Launch Readiness for RP1
The company is fully prepared for the commercial launch of RP1, with a trained customer-facing team, established distribution model, and patient support hub ready to ensure broad and rapid adoption.
Financial Stability and Cash Runway
Replimune ended the fiscal year with $483.8 million in cash and equivalents, projecting a cash runway into the fourth quarter of 2026.
Commercial Infrastructure Developed
Built a commercial organization comprising approximately 60 people focused on demand generation and support for RP1 launch.