Nuvation Bio Inc. (NYSE:NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced preliminary fourth quarter and full year 2025 net product revenue for IBTROZI® (taletrectinib) and provided a 2026 outlook ahead of its presentation at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, CA.
Preliminary Fourth Quarter and Full Year 2025 Financial Results and IBTROZI Commercial Results
- In the third quarter, the company's first full quarter of sales, 204 new patients started treatment on IBTROZI for advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)
- In the fourth quarter, 216 new patients started treatment on IBTROZI for advanced ROS1+ NSCLC, exceeding internal projections and in spite of the holiday-adjacent weeks where new patient starts can be limited in this rare disease
- With 432 new patients started since launch in the second half of June, the treatment adoption rate is approximately six times greater than that of prior recent ROS1 tyrosine kinase inhibitor (TKI) launches based on IQVIA data
- Preliminary fourth quarter and full year 2025 IBTROZI net product revenue was $15.7 million and $24.7 million, respectively
- Received $25 million milestone payment from Nippon Kayaku as a result of establishment of the reimbursement price in Japan in Q4
- Preliminary unaudited cash, cash equivalents and marketable securities are expected to be approximately $529.2 million as of December 31, 2025
2026 Priorities and Upcoming Milestones
- Continue to grow IBTROZI new patient starts in advanced ROS1+ NSCLC, particularly in the first-line setting, while supporting continuity of therapy for current patients to achieve maximum potential benefits
- Entered exclusive license and collaboration agreement with Eisai Co., Ltd. on January 11, 2026 to develop, register and commercialize taletrectinib for the treatment of ROS1+ NSCLC in Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam and India
- Advance the pipeline, including:
- Continue enrollment of G203 as a phase 3, registration-enabling study evaluating safusidenib in high-grade and high-risk IDH1-mutant gliomas
- Ongoing evaluation of preclinical candidates from our drug-drug conjugate (DDC) platform
- Pursue business development opportunities to expand the pipeline and further our mission of tackling some of the toughest challenges in cancer treatment
- Maintain a robust cash position and strong balance sheet that can support continued investment in future growth
"2025 was a defining year for Nuvation Bio as we evolved into a commercial-stage company with the mid-June FDA approval of IBTROZI in the U.S.," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "In just two full quarters of commercial launch, IBTROZI is now the preferred TKI for people living with advanced ROS1+ NSCLC and their healthcare providers, becoming the new standard of care across treatment lines. This rapid adoption reflects confidence in IBTROZI's impressive duration of response of over four years and its manageable safety profile.
"We are also incredibly excited about the potential of safusidenib, which delivered promising clinical results in grade 2 IDH1-mutant gliomas and is now in a pivotal trial for high-grade disease as well as low-grade disease with high-risk features, where significant patient needs are unaddressed by the current standard of care. We believe that 2026 will be another important year for our company with a continued focus on bringing IBTROZI to even more patients in the U.S. and around the world, and progressing our promising pipeline with urgency."
The 2025 net product revenues and cash, cash equivalents and marketable securities included in this release are preliminary and are therefore subject to adjustment. The preliminary net product revenue results are based on management's initial analysis of operations for the year ended December 31, 2025. The Company expects to issue full financial results for the fourth-quarter and full-year 2025 in March 2026.
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