Replimune reports a wider fiscal 2026 net loss as the FDA accepts its RP1 application for review.

Replimune, a clinical-stage biotechnology company, reported no revenue for its fourth quarter or fiscal year 2026. The company posted a net loss of $73.7 million for the fourth quarter and a full-year net loss of $313.9 million, or ($3.38) per share. Replimune ended the fiscal year with $268.9 million in cash and short-term investments.

Key Highlights

• The U.S. FDA accepted the resubmission of the Biologics License Application (BLA) for its lead candidate RP1, setting an action goal date of August 2, 2026.
• Cash, cash equivalents, and short-term investments decreased to $268.9 million from $483.8 million a year prior, with the current balance expected to fund operations into the first quarter of calendar 2027.
• Full-year research and development expenses increased to $221.2 million from $189.4 million in the prior year, driven by costs related to preparations for a potential commercial launch of RP1.