Nuvation Bio (NYSE:NUVB) executives highlighted the company’s first full year of commercial activity for IBTROZI and outlined late-stage development plans for safusidenib during the company’s fourth-quarter and full-year 2025 results call. Management emphasized accelerating patient uptake for IBTROZI following its June 2025 U.S. approval, progress on global partnering, and the initiation of a pivotal Phase III trial for safusidenib in IDH1-mutant glioma.
IBTROZI launch: patient starts and adoption trends
CEO Dr. David Hung described 2025 as a “pivotal year” driven by the June 11 full U.S. FDA approval of IBTROZI for advanced ROS1-positive non-small cell lung cancer (NSCLC). By year-end, the company reported 432 new patients started on IBTROZI, including 216 in the fourth quarter. Hung said the company believes IBTROZI is becoming a new standard of care, citing feedback from key opinion leaders and prescribers as well as market research.
Chief Commercial Officer Colleen Sjogren said IBTROZI has been prescribed in all 47 sales territories, with repeat prescribers across the footprint. She added that by the end of 2025, the company had engaged all “top-tier target accounts,” and that per IQVIA the company has shown “significant growth in market share of new patients treated with a ROS1 TKI.”
Market access, discontinuations, and the shift toward first-line use
On payer coverage and access, Sjogren said engagement has been “constructive and effective,” and that Nuvation has achieved “broad coverage to label” nationwide. The company’s patient support program, NuvationConnect, is used to help eligible patients access IBTROZI while reimbursement is secured.
Executives repeatedly addressed the difference between strong early patient-start metrics and near-term revenue growth, attributing it to the early mix skewing toward later-line patients. Sjogren said that within the subset of patients visible through the hub and specialty pharmacy channels, about 75% of discontinuations in 2025 came from later-line populations. Management argued that as use shifts upstream, discontinuations should decrease and the relationship between new patient starts and revenue should tighten.
Sjogren also described a shift in prescribing sites. As of the end of 2025, approximately 70% of new patient starts came from academic centers or integrated delivery networks (IDNs) and 30% from community centers, compared with a 75%/25% split at the end of the third quarter. She said broader community adoption is expected over time because many ROS1 patients are treated outside academic centers.
In discussing patient identification, Sjogren said DNA-based testing should identify roughly 3,000 advanced ROS1-positive NSCLC patients annually in the U.S., and that increased use of RNA-based testing could potentially expand detection by about 30%, to roughly 4,000 advanced patients annually.
Clinical positioning: durability, CNS disease, and TRKB discussion
Hung reiterated previously disclosed long-term data, noting that as of an August 2025 cutoff, IBTROZI’s median duration of response reached 50 months in a pooled analysis of TKI-naive patients in the TRUST-I and TRUST-II studies, alongside a previously reported 89% confirmed overall response rate in that population. He said the company plans to present additional long-term data and analyses in 2026, including further scientific characterization of IBTROZI’s activity against ROS1 and TRKB.
Hung argued that controlling brain metastases is critical in ROS1-positive lung cancer, citing that 36% of newly diagnosed patients present with brain metastases and that in an additional 50% the first site of progression will be in the brain. He described IBTROZI as 11–20 fold more selective for ROS1 over TRKB while retaining measured TRKB inhibitory activity, and referenced a Journal of Thoracic Oncology commentary that hypothesized this selectivity could support tolerability.
During Q&A, Hung criticized the continued first-line use of crizotinib due to its lack of blood-brain barrier penetration, and said the company is evaluating strategies to have IBTROZI’s differentiation reflected in NCCN guidelines, adding “stay tuned” on that effort.
Safusidenib: pivotal SIGMA study launched, additional cohort added
Nuvation also outlined progress for safusidenib, an inhibitor of mutant IDH1 being developed for IDH1-mutant glioma. Hung framed the market by noting approximately 2,400 new U.S. cases annually, split almost evenly between low-grade and high-grade disease, and contrasted survival expectations by grade.
The company highlighted published Phase II data in low-grade IDH1-mutant glioma (27 patients) showing a median progression-free survival not reached, a 12% progression rate at 24 months, and a confirmed overall response rate of 44%. Management compared those figures to vorasidenib’s INDIGO study results in grade 2 disease (median PFS of 27.7 months, 41% progression at 24 months, and 11% ORR), while also cautioning about limitations of cross-trial comparisons. Hung also cited a Phase I safusidenib experience in a high-grade enhancing population showing a 17% confirmed ORR, including two complete responses lasting multiple years.
Hung said the company began enrolling the global pivotal Phase III SIGMA trial in February. The randomized study will evaluate safusidenib versus placebo as maintenance treatment following standard of care, enrolling 300 patients including grade 2/3 astrocytoma with high-risk features and all grade 4 astrocytoma patients. The company expects a 2029 readout and said there are no current plans for an interim analysis. A separate, non-pivotal cohort in grade 3 oligodendroglioma is expected to enroll about 40 patients and read out in 2027 with overall response rate as the primary endpoint; Hung said that if ORR is “anywhere north of 20%,” the company would view that as extremely interesting for potential accelerated approval discussions, given vorasidenib’s reported 0% confirmed ORR in a high-grade enhancing population.
Financial results, partnerships, and cash runway
CFO Philippe Sauvage reported fourth-quarter 2025 total revenue of $41.9 million and full-year 2025 revenue of $62.9 million. The company posted IBTROZI net U.S. product revenue of $15.7 million in Q4 and $24.7 million for the full year. Sauvage said the company believes channel inventory is approximately two to four weeks, which he characterized as standard, and noted that prescriptions filled through the free trial program convert to full commercial revenue by the second month on therapy at the latest.
Sauvage said gross-to-net was around 25% and is expected to increase slightly before stabilizing over the long term. On expenses, the company reported R&D of $34.3 million in Q4 and $115.1 million for 2025, and SG&A of $40.3 million in Q4 and $151.6 million for 2025, primarily driven by commercialization. He said Nuvation does not expect material increases in commercial headcount going forward.
Nuvation ended 2025 with $529.2 million in cash, cash equivalents, and marketable securities, which Sauvage said increased by roughly $60 million following an upfront payment tied to its Europe-focused partnership with Eisai. Management also referenced $50 million remaining available under a term loan agreement with Sagard Healthcare Partners through June 30, 2026. Based on its operating plan, revenue trajectory, and expense management, the company said it does not anticipate needing additional external financing to reach profitability.
On partnering, management noted royalty revenue from China partner Innovent Biologics and the start of royalty revenue from Japan partner Nippon Kayaku following regulatory approval and reimbursement in November, an event tied to a $25 million milestone payment. Executives also discussed the January partnership with Eisai to develop IBTROZI in Europe and select ex-U.S. territories outside China and Japan, with plans to submit for European approval in the first half of 2026; Hung said the company does not believe additional clinical trials will be required for Europe, with more details expected after submission.
Finally, Hung addressed the company’s drug-drug conjugate (DDC) platform, confirming that development of NUV-1511 was discontinued in Q4, but said the program generated learnings now being applied to new preclinical candidates, with updates targeted by year-end.
About Nuvation Bio (NYSE:NUVB)
Nuvation Bio is a clinical-stage biotechnology company dedicated to discovering and developing small-molecule therapies for patients with cancer. The company employs an integrated research and development platform that spans target identification, preclinical evaluation, process chemistry, and early-stage clinical trials. By centralizing these capabilities, Nuvation Bio aims to accelerate the translation of promising drug candidates from laboratory research to first-in-human studies.
The company’s pipeline comprises multiple oncology programs, with small-molecule kinase inhibitors and targeted agents in Phase 1 development for both hematologic malignancies and solid tumors.
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