FDA Accepts RP1 BLA with August 2 Decision Date, Cash Falls to $268.9M
REPL•FDA accepted the RP1 plus nivolumab BLA, granting a class 1 review with a target decision on August 2, 2026 and scheduling an advisory committee meeting in late July. Cash fell to $268.9 million from $483.8 million, providing runway into Q1 2027; R&D expenses rose to $221.2 million.
1. FDA Acceptance of RP1 BLA
The FDA accepted the RP1 plus nivolumab BLA for advanced melanoma, granting a complete class 1 review with a target decision date of August 2, 2026 and notifying the company of an advisory committee meeting in late July.
2. Clinical Program Progress
Data presented at the ASCO meeting showed RP1 plus nivolumab achieved 47.8% overall survival at three years and a median overall survival of 32.9 months, including an 83.5% three-year survival rate among responders; the global Phase 3 IGNYTE-3 confirmatory study is actively enrolling, and the Phase 2/3 REVEAL trial of RP2 in metastatic uveal melanoma is underway.
3. Financial Position and Expenditures
As of March 31, 2026, cash and short-term investments stood at $268.9 million, down from $483.8 million a year earlier, providing funding into the first quarter of 2027; research and development expenses rose to $221.2 million for the fiscal year ended March 31, 2026.
