Emiltatug Ledadotin (XMT-1660) - (Emi-Le)

Jan. 11, 2026: Day One Biopharmaceuticals, Inc. (NASDAQ: DAWN) reported preliminary unaudited 2025 OJEMDA (tovorafenib) net product revenue of ~$52.8 million for Q4 2025 and ~$155.4 million for full-year 2025, citing ~37% quarter-over-quarter growth and ~172% year-over-year growth; Q4 prescription volumes were 1,394. The company guided to 2026 U.S. OJEMDA net product revenue of $225–$250 million.

Key 2026 milestones:

• OJEMDA (pediatric low-grade glioma, pLGG): complete enrollment in the pivotal Phase 3 FIREFLY-2 trial in first-line pLGG in 1H 2026; company targets a mid-2027 data readout and cites a potential approval in 2028. Also plans ex-U.S. expansion via a partner.
• Emi-Le (emiltatug ledadotin; B7-H4 ADC, adenoid cystic carcinoma): deliver Phase 1 clinical data by mid-2026 and progress toward registration.
• DAY301 (PTK7-targeted ADC): provide initial Phase 1a clinical trial data in 2H 2026.

Day One also disclosed ~$441.1 million in cash/cash equivalents/short-term investments as of Dec. 31, 2025 (prior to the Mersana acquisition) and said it expects to report full Q4/FY 2025 financial results in February 2026. CEO Jeremy Bender is scheduled to present at the J.P. Morgan Healthcare Conference on Jan. 12, 2026 (5:15 pm PT).