Replimune reports fiscal 2026 results and BLA progress for RP1
- Replimune (NASDAQ:REPL) reported fiscal 2026 net loss of $313.9 million with cash of $268.9 million as of March 31, 2026.
- The FDA accepted the resubmitted BLA for RP1 plus nivolumab in advanced melanoma as a Class 1 response with August 2, 2026 goal date.
- RP1 3-year data showed 47.8% survival at 3 years and 83.5% among responders in anti-PD-1 failed melanoma.
Replimune (NASDAQ:REPL) reported fiscal 2026 results with a net loss of $313.9 million, research and development expenses of $221.2 million, and selling, general and administrative expenses of $98.7 million.
The company ended the year with cash, cash equivalents and short-term investments of $268.9 million, down from $483.8 million a year earlier, which is expected to fund operations into the first quarter of 2027.
The FDA accepted the resubmitted Biologics License Application for RP1 plus nivolumab in advanced melanoma as a Class 1 response, with a target action date of August 2, 2026 and an advisory committee meeting expected in late July.
RP1 3-year data in anti-PD-1-failed melanoma showed 47.8% of treated patients alive at 3 years with median overall survival of 32.9 months, and 83.5% 3-year survival among responders.
RP2 Phase 1 data yielded a 19% objective response rate as monotherapy and in combination with nivolumab across advanced solid tumors, supporting advancement into the REVEAL Phase 2/3 trial in metastatic uveal melanoma.
