Nuvation Bio (NYSE:NUVB) reported second-quarter total revenue of $31.7 million, including $23.2 million in net U.S. product revenue from IBTROZI, as the company said use of the ROS1-targeted lung cancer therapy continued to shift toward first-line patients.
IBTROZI revenue increased 25% from the first quarter, while approximately 160 patients began treatment during the period, Chief Executive Officer David Hung said. About 85% of those new starts were in the first-line setting, compared with roughly 30% at launch less than a year earlier. The company said first-line starts rose about 30% sequentially.
IBTROZI adoption shifts toward first-line use
“We expected first-line patients to become the main driver of long-term growth due to the much longer duration of treatment in the first-line setting, and we see this dynamic happening in real time,” Hung said.
Chief Commercial Officer Colleen Sjogren said IQVIA claims data from January through May showed IBTROZI was the most prescribed ROS1 tyrosine kinase inhibitor, or TKI, across all treatment lines in 2026. She added that physicians chose IBTROZI for more than half of newly treated first-line patients during that period.
The company cited data from its TRUST-I study in TKI-naive patients, where IBTROZI demonstrated a 90% objective response rate and median duration of response and progression-free survival of 50 months. Hung also pointed to patient-reported outcomes from TRUST-II presented at the American Society of Clinical Oncology meeting, where 88% of patients reported improved or stable global health and quality-of-life scores at the first assessment.
Nuvation said adverse-event-driven discontinuations have remained low, with discontinuations concentrated among later-line patients with more extensive disease and prior treatment exposure. The company also said IBTROZI is the only brain-penetrant ROS1 TKI without central nervous system warnings in its label.
During the question-and-answer session, management discussed a newly approved competing ROS1 therapy from GSK, referred to on the call as zidesamtinib. Hung said Nuvation was surprised by CNS warnings and other adverse events included in that therapy’s label, while Chief Financial Officer Philippe Sauvage characterized its pricing as consistent with a later-line treatment strategy. Nuvation said the earlier-than-expected approval of the competing drug did not alter its commercial plan.
Sjogren said demand for IBTROZI has grown across academic centers, community practices and integrated delivery networks. Academic accounts represented about 50% of the company’s business, she said.
Company targets broader testing and treatment uptake
Management said more ROS1-positive lung cancer patients are receiving targeted therapy in the first-line setting, though some patients continue to receive chemotherapy and immunotherapy despite current treatment guidelines.
According to Sjogren, the number of patients receiving any ROS1 TKI in the first-line setting increased nearly 20% from IBTROZI’s launch through May 2026 compared with the prior-year period, based on IQVIA claims data.
Hung said the company has worked with community oncology organizations to improve testing rates and awareness of treatment patterns. He said some centers were unaware that their genetic testing rates were lower than expected and that Nuvation had helped certain centers more than double their testing rates. The company is also advocating for RNA-based testing, which management said is more sensitive than DNA testing for identifying ROS1 fusions.
Safusidenib program expands across glioma settings
Nuvation also outlined an expanded clinical development plan for safusidenib, its investigational therapy for IDH1-mutant glioma. The company recently reported updated Phase II J201 results in 27 patients with chemotherapy- and radiotherapy-naive Grade 2 IDH1-mutant glioma.
With median follow-up of 39 months, centrally assessed objective response rate rose to 52% from 44% at 28 months of follow-up, while median progression-free survival had not been reached and the 36-month progression-free survival rate was 79%, Hung said. No new safety signals were observed with additional follow-up.
The company announced two additional studies for lower-grade, lower-risk disease:
- G307: A randomized Phase III trial enrolling 140 patients with newly diagnosed Grade 2 IDH1-mutant glioma who have not received chemotherapy or radiation. The study will be conducted outside the U.S. in regions where vorasidenib is not approved or accessible, with progression-free survival as the primary endpoint.
- G209: A U.S. Phase II study enrolling up to 40 patients with Grade 2 or Grade 3 IDH1-mutant glioma whose disease progressed after vorasidenib treatment but who do not yet require chemotherapy or radiation. The primary endpoint is objective response rate.
Hung said the company expects data from its Phase III SIGMA and G307 studies in 2029. Nuvation also plans to assess tumor growth rate as a possible earlier indicator of activity in exploratory studies, though management noted it is not a validated regulatory endpoint.
Balance sheet strengthened through convertible notes offering
Operating expenses totaled $73.3 million in the second quarter, including $30.7 million in research and development expense and $42.6 million in selling, general and administrative expense. For the first six months of 2026, Nuvation reported total revenue of $114.9 million, including $41.7 million of IBTROZI net U.S. product revenue.
Cash, cash equivalents and marketable securities totaled $661 million as of June 30. During June, Nuvation completed an offering of 0.75% convertible senior notes due 2032, generating approximately $279.1 million in net proceeds before the subsequent overallotment exercise. The company used proceeds to repay its outstanding term loan with Sagard and said the transaction reduced expected cash interest expense.
Sauvage said Nuvation continues to believe its capital is sufficient to reach profitability and support the anticipated launch of safusidenib. The company also said it remains on track to provide an update on its drug-drug conjugate platform by the end of 2026.
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.
