Nuvation Bio (NYSE:NUVB) reported $45 million in third-quarter 2026 revenue as U.S. sales of lung cancer treatment IBTROZI rose 18% from the previous quarter, even as the company said new patient starts declined across the broader ROS1 treatment market.
IBTROZI generated $27.5 million in net U.S. product revenue during the quarter, with approximately 160 new patients starting treatment, Chief Executive Officer David Hung said on the company’s earnings call. About 65% of those patients were receiving the drug as their first treatment for ROS1-positive lung cancer.
Hung said IQVIA claims data showed a 15% decline in new patient starts across the ROS1 tyrosine kinase inhibitor, or TKI, market during the quarter. The company also saw fewer alerts from laboratory partners identifying ROS1-positive patients. Management said it was too early to determine whether the decline represented a lasting trend.
“Quarterly new patient activity will not always move in a straight line,” Hung said, adding that Nuvation Bio was monitoring treatment patterns while working to improve patient identification and biomarker testing.
IBTROZI Gains Active Patient Share
Chief Commercial Officer Colleen Sjogren said IQVIA claims data showed IBTROZI became the leading ROS1 TKI by total active patients across all lines of therapy during the quarter. The drug also held more than 60% of first-line new patient starts at quarter-end, management said.
Sjogren said the pool of patients available to switch from older ROS1 treatments has narrowed since IBTROZI’s launch, making newly diagnosed patients increasingly important to future growth. She said the company sees opportunities to increase testing and help physicians incorporate molecular results before starting treatment.
During the question-and-answer session, Hung said Nuvation Bio expected IBTROZI revenue growth to continue at roughly the pace seen previously. He did not explicitly endorse an analyst’s question about whether $108 million in full-year sales was an appropriate estimate.
Management also addressed competition, including the potential for zidesamtinib to receive a first-line indication. Hung pointed to IBTROZI’s clinical data and tolerability profile, while Sjogren said the company would continue competing on the totality of evidence and commercial execution rather than assuming its market share was permanent.
Safusidenib Studies Advance
Nuvation Bio is advancing four studies of safusidenib in patients with IDH1-mutant glioma. The U.S. Food and Drug Administration granted the drug Fast Track designation in August, Hung said.
In July, the company reported updated results from a phase 2 study involving 27 patients with grade 2 IDH1-mutant glioma who had not received chemotherapy or radiotherapy. The centrally assessed objective response rate was 52% at a median follow-up of 39 months, up from 44% at 28 months of follow-up. Median progression-free survival had not been reached, and the 36-month progression-free survival rate was 79%, Hung said.
Two studies—in grade 3 oligodendroglioma and in patients whose disease progressed after vorasidenib—use objective response rate as a primary endpoint. Hung said the company could begin seeing data from the oligodendroglioma study around mid-2027 and expected responses in the post-vorasidenib study during 2027. He did not specify which study would read out first.
The other two randomized studies use progression-free survival as their primary endpoint and are not expected to produce data until 2029 or later. Tumor growth rate is a secondary endpoint in the response-rate studies, but Hung cautioned that the FDA had not accepted it as an endpoint and that the company was not assuming it would do so.
Hung said more detailed phase 2 data on the depth and durability of responses would be presented at the Society for Neuro-Oncology Annual Meeting the following week. The company also expects to provide an update on its drug-drug conjugate platform by year-end.
Cash Position and Spending
Third-quarter revenue included $17.5 million from collaborations and licenses in addition to IBTROZI’s U.S. sales. For the first nine months of 2026, total revenue was $159.9 million, including $69.2 million in U.S. IBTROZI sales.
Chief Financial Officer Philippe Sauvage said launches by partners in China and Japan were progressing ahead of company expectations. Nuvation Bio anticipates a potential European approval in the first half of 2027, which would trigger an approximately $30 million milestone payment from partner Eisai, he said.
Quarterly operating expenses were $75.2 million, including $32.7 million in research and development expenses and $42.6 million in selling, general and administrative expenses. Sauvage said the company did not expect material changes to its general spending patterns for the remainder of the year.
Nuvation Bio held $663.4 million in cash equivalents and marketable securities as of Sept. 30, including proceeds from its summer convertible debt offering. Based on its internal revenue projections and current operating plan, management said it continued to believe it had sufficient capital to reach profitability.
About Nuvation Bio (NYSE:NUVB)
Nuvation Bio, Inc is a biopharmaceutical company focused on discovering, developing and commercializing medicines for patients with cancer. The company seeks to address areas of significant unmet need, with an emphasis on targeted therapies for solid tumors.
Nuvation Bio’s lead product is taletrectinib, a next-generation tyrosine kinase inhibitor designed for patients with ROS1-positive non-small cell lung cancer (NSCLC), including certain tumors that have developed resistance to earlier ROS1-targeted treatments.
