Net loss increased to $512.5 million in 2025, up from $422.8 million in 2024 and $145.2 million in 2023. Cash, cash equivalents, and marketable securities totaled $966.2 million as of December 31, 2025. The Biologics License Application (BLA) for tividenofusp alfa (DNL310) for Hunter syndrome is under priority review by the FDA, with a PDUFA target action date extended to April 5, 2026, due to updated clinical pharmacology data. Preliminary Phase 1/2 data for DNL126 (ETV:SGSH) for Sanfilippo syndrome Type A showed robust reductions in CSF heparan sulfate (80%) and CSF GM3 (61%) at Week 49, with a safety profile consistent with other enzyme replacement therapies. The Investigational New Drug (IND) application for DNL952 (ETV:GAA) for Pompe disease was initially placed on clinical hold but was lifted in January 2026 after protocol amendments. A Clinical Trial Application (CTA) for DNL628 (OTV:MAPT) for Alzheimer's disease was approved, with a Phase 1b study underway. Biogen completed enrollment in the Phase 2b LUMA study for BIIB122/DNL151 (LRRK2 inhibitor) for Parkinson's disease, with data expected in mid-2026. The Phase 2/3 HEALEY ALS Platform Trial evaluating DNL343 for ALS did not meet primary and key secondary endpoints, leading to the discontinuation of the active treatment extension. Collaborations with Biogen and Takeda saw terminations of the ATV:Abeta program license and the ATV:TREM2 program, respectively. A synthetic royalty funding agreement with Royalty Pharma plc was entered into in December 2025, providing up to $275.0 million in funding in exchange for a 9.25% royalty on future net sales of tividenofusp alfa, contingent on FDA accelerated approval by June 30, 2026. The company opened a clinical biomanufacturing facility in Salt Lake City, Utah, in early 2025.