Day One Biopharmaceuticals delivered exceptional commercial performance for its pediatric cancer therapy OJEMDA (tovorafenib) in the second quarter of 2025, with net product revenue surging 310% year-over-year to $33.6 million. The clinical-stage biopharmaceutical company, which focuses on developing therapies for pediatric cancers and rare tumor types, reported total quarterly revenue of $33.9 million, narrowly missing analyst consensus expectations of $34.9 million.
Strong Commercial Momentum Drives Prescription Growth
The company achieved significant milestones in OJEMDA adoption, writing more than 1,000 prescriptions during the quarter—a 15% sequential increase and a remarkable 346% rise compared to the prior year period. Management attributed this strong underlying momentum to on-label prescription growth, wider acceptance across high-priority treatment centers, and particularly deep adoption among pediatric oncologists.
OJEMDA's unique positioning as the only systemic, once-weekly therapy for pediatric low-grade glioma patients has reinforced its strong market fit despite traditionally conservative physician prescribing habits in pediatric oncology. The U.S. commercial rollout has benefited from expanding the pool of experienced prescribers and more patients staying on therapy for longer durations.
Operational Efficiency and Cost Management
Operating expenses declined sharply compared to the prior year period, with research and development expenses falling 60.8% to $36.1 million from $92.1 million in Q2 2024. This decrease was primarily attributed to the absence of the MabCare Therapeutics license agreement upfront payment of $55.0 million that occurred in the prior year period.
Selling, general, and administrative expenses also decreased slightly to $29.0 million, reflecting lower employee compensation and continued efficiency measures. The normalized loss level remains consistent with ongoing investment in commercialization and future pipeline growth.
Pipeline Development and Strategic Focus
Pipeline development advanced on multiple fronts during the quarter. DAY301, a targeted antibody-drug conjugate for solid tumors, continues enrolling patients in its early-stage clinical trial. Two pivotal trials for OJEMDA—FIREFLY-1 (long-term follow-up) and FIREFLY-2 (designed to support full regulatory approval)—remain on track.
Strategically, Day One decided to end its VRK1 inhibitor collaboration, prioritizing resources for its most promising programs. The company also strengthened its leadership team by bringing in a new head of research and development in June.
Financial Position and Future Outlook
Day One ended the quarter with $453.1 million in cash, cash equivalents, and short-term investments, down from $531.7 million at year-end 2024. Management reiterated that available cash is expected to fund both commercial and research activities for the foreseeable future, with no need for external financing anticipated.
The company reaffirmed net product revenue guidance for OJEMDA between $140 million and $150 million for 2025, signaling management's confidence in continued U.S. market expansion. Key clinical data from OJEMDA is expected to be available in late 2025 and early 2026, with key inflection points including the three-year FIREFLY-1 data and completion of FIREFLY-2 enrollment.
OJEMDA is an oral inhibitor that targets specific genetic alterations commonly found in pediatric low-grade glioma, a type of brain tumor in children. The company's approach involves licensing, developing, and commercializing innovative oncology drugs through strategic partnerships, including collaborations with Ipsen for non-U.S. markets and MabCare for pipeline expansion.
