Quarterly ResultJun 29, 2026, 08:17 AM
Replimune Q4/FY26 Results; FDA Accepts RP1 BLA Resubmission
AI Summary
Replimune Group, Inc. announced its fiscal fourth quarter and year-end 2026 financial results, reporting a net loss of $313.9 million for the year. The company also provided a corporate update, highlighting the FDA's acceptance of the Biologics License Application (BLA) resubmission for RP1 in combination with nivolumab for advanced melanoma, with a goal date of August 2, 2026. Clinical trials for RP1 and RP2 continue to progress, with positive durability data for RP1 and promising efficacy for RP2 in solid tumors. Cash reserves stood at $268.9 million, projected to fund operations into Q1 2027.
Key Highlights
- FDA accepted BLA resubmission for RP1 in advanced melanoma with August 2, 2026 goal date.
- IGNYTE trial (RP1 + nivolumab) showed 47.8% 3-year overall survival in anti-PD-1-failed melanoma.
- RP2 Phase 1 trial demonstrated 19% objective response rate in advanced solid tumors.
- Cash, cash equivalents, and short-term investments were $268.9 million as of March 31, 2026.
- Net loss for fiscal year 2026 was $313.9 million, up from $247.3 million in 2025.
- R&D expenses increased to $221.2 million for fiscal year 2026 from $189.4 million.
- SG&A expenses rose to $98.7 million for fiscal year 2026 from $72.2 million.
- Existing cash is expected to fund operations into the first quarter of calendar 2027.
Price Impact
More from REPL