OJEMDA (tovorafenib) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, recommending conditional marketing authorization for relapsed or refractory BRAF-altered pediatric low-grade glioma (pLGG). Ipsen Pharma SAS holds exclusive license rights to commercialize OJEMDA outside of the United States, as per an agreement from July 2024. U.S. net product revenue for OJEMDA reached $155.4 million in 2025, a 172% increase from 2024, with 4,635 prescriptions. The company projects 2026 U.S. net product revenue for OJEMDA to be between $225 million and $250 million, representing over 50% growth from 2025. Three-year follow-up data from the FIREFLY-1 pivotal Phase 2 trial for OJEMDA reinforced its durability, showing a median duration of response of 19.4 months and a median time to next treatment of 42.6 months. 77% of patients in the post-treatment observation period were treatment-free for at least 12 months, with no new safety signals observed. The FIREFLY-2 pivotal Phase 3 trial for front-line pLGG is expected to complete enrollment in the first half of 2026, with topline data anticipated mid-2027, potentially leading to approval in 2028. The pipeline includes Emi-Le (emiltatug ledadotin), a B7-H4-targeted antibody-drug conjugate (ADC) for Adenoid Cystic Carcinoma (ACC), with Phase 1 data expected mid-2026. DAY301, a PTK7-targeted ADC, is also in development with Phase 1a data expected in the second half of 2026. Cash, cash equivalents, and short-term investments totaled $441.1 million as of December 31, 2025. The net loss for the full year ended December 31, 2025, was $107.3 million, compared to a net loss of $95.5 million in 2024.