Day One Announces Preliminary 2025 OJEMDA™ Net Product Revenue And Provides 2026 Net Product Revenue Guidance

Core Insights - Day One Biopharmaceuticals reported preliminary 2025 net product revenue of $155.4 million, reflecting a 172% year-over-year growth, with 2026 U.S. net product revenue projected to be between $225 million and $250 million [1][6] - The company is set to present its corporate progress and priorities for 2026 at the J.P. Morgan Healthcare Conference on January 12, 2026 [1][6] 2025 OJEMDA Commercial Performance - OJEMDA net product revenue for Q4 2025 was approximately $52.8 million, contributing to the full-year revenue of $155.4 million, marking a 37% quarter-over-quarter growth and a 172% year-over-year growth [6] - The increase in revenue was driven by rising patient demand, with prescription volumes reaching 1,394 in Q4 2025 [6] 2026 Corporate Priorities and Key Milestones - The company aims to achieve 2026 OJEMDA net product revenue guidance, focusing on increasing persistency and driving new patient starts to establish OJEMDA as the standard of care in second-line pediatric low-grade glioma (pLGG) [6] - Plans include global expansion of OJEMDA beyond the U.S. through partnerships [6] - Completion of enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial for first-line pLGG is expected in the first half of 2026, with data readout anticipated in mid-2027 and potential approval in 2028 [6] - The Emi-Le program is set to deliver Phase 1 clinical data by mid-2026, progressing towards registration [6] - Initial data from the Phase 1a clinical trial for DAY301, a PTK7-targeted antibody drug conjugate, is expected in the second half of 2026 [6] Financial Position - As of December 31, 2025, prior to the acquisition of Mersana, Day One had approximately $441.1 million in cash, cash equivalents, and short-term investments [5]