Nuvation Bio NYSE: NUVB executives said the company made continued commercial progress with ROS1-positive non-small cell lung cancer (NSCLC) therapy Ibtrozi during the first quarter of 2026, pointing to steady new patient demand, a shifting mix toward first-line use, and rising product revenue as more patients remain on treatment longer.
Commercial launch trends for Ibtrozi
Founder, President and CEO Dr. David Hung said the company treated “approximately 200 new patients” with Ibtrozi during the quarter, marking “3 consecutive quarters of about 200 new patient starts,” and bringing the total to “over 600 since launch.” Hung emphasized that the mix of new starts continued to move toward earlier treatment, noting that for the first time since launch “more than half of the new patients who started Ibtrozi in the quarter were TKI naive.”
Hung said the move into earlier lines matters financially because of longer durability when Ibtrozi is used earlier, adding that the company is “just beginning to see revenue stacking this quarter.” He also said that over time the company expects to focus more on revenue growth and “at some point in the future… no longer report new patient starts.”
Chief Commercial Officer Colleen Sjogren said internal data show Nuvation’s launch is tracking ahead of prior ROS1 targeted therapy launches, stating the company has generated “more new patient starts than the prior ROS1 launches combined over the same time period.” She also highlighted broad adoption across settings, citing market research showing aided awareness of Ibtrozi among target physicians has reached “97%,” and that “100% of the top 50 historical TKI accounts in the country have prescribed Ibtrozi.”
Updated data and guideline developments
Hung pointed to updated clinical results presented at AACR from TRUST-I and TRUST-II, including in TKI-naive patients where median duration of response and median progression-free survival “have both now increased to approximately 50 months or more than 4 years” in TRUST-I, as published in the Journal of Clinical Oncology. In TKI pre-treated patients, he said median duration of response was “nearly 20 months” in TRUST-II, and overall survival in the pooled TKI pre-treated population was “nearly 30 months,” which he described as “unprecedented in this space.”
Hung said longer follow-up continued to show a “manageable and consistent safety profile,” including “low rates of neurologic adverse events and no new safety signals.” He reiterated discontinuation data from the prescribing information, stating that 6.5% of 337 patients in the pivotal TRUST studies discontinued due to any adverse reaction, and that only 0.3% discontinued due to any of the six most common adverse events listed.
The company also highlighted the addition of Ibtrozi to the latest CNS National Comprehensive Cancer Network (NCCN) guidelines as a systemic therapy option for ROS1-positive NSCLC patients with brain metastases. Hung said the CNS discussion is important given disease characteristics, noting that “36% of ROS1 begins in the brain at first diagnosis, and then another 50% will progress in the brain upon first progression.”
During Q&A, Hung contrasted Ibtrozi’s CNS profile with crizotinib, which he said “doesn't even get into the brain,” and argued that the NCCN CNS guideline language reinforces the importance of selecting CNS-penetrant therapy. Sjogren added the company has received early healthcare provider feedback indicating the guideline inclusion will “enhance Ibtrozi’s profile and really impact their treatment decision.”
Testing initiatives and first-line adoption
Executives repeatedly returned to molecular testing rates as a key driver of future growth. Sjogren estimated there should be “approximately 3,000 patients” with advanced ROS1-positive NSCLC diagnosed annually in the U.S. based on DNA testing, and said the addressable population could expand to “approximately 4,000” as RNA and DNA-based testing are used together, which she said may detect an additional 30% of fusions.
However, she said testing is “significantly lower in parts of the community, including below 50% in some centers.” Sjogren said Nuvation is partnering with community oncology practices, investing in educational initiatives, and working with testing platforms to make comprehensive molecular testing “the standard of care and not the exception.” Hung added that diagnoses are currently higher in academic sites “because that's where more testing is being done,” though he said the company has already seen improvement in multiple community centers.
Financial results and cash position
Chief Financial Officer Philippe Sauvage reported $83.2 million in total revenue for the first quarter, including $18.5 million in Ibtrozi net U.S. product revenue. Sauvage said Ibtrozi net product revenue increased 18% from the prior quarter, driven by both continued new patient starts and a “growing population of active patients remaining on Ibtrozi due to increasing frontline use.” He described a quarter-to-quarter shift in first-line starts from approximately 30% to 40% to “now more than 50%,” alongside net product revenue growth from $7.7 million to $15.7 million to $18.5 million.
In addition to product revenue, Nuvation recognized $64.7 million in collaboration and license revenue, including “an upfront payment of nearly $60 million from Eisai” tied to a partnership announced in January. The company also received about $1.7 million in royalty payments from partnerships in Japan and China, which Sauvage said are “exceeding initial expectations on a new patient start and net revenue basis.”
Nuvation reported total operating expenses of $73.5 million, including $35 million in R&D expenses and $38.3 million in SG&A expenses. The company ended the quarter with $533.7 million in cash, cash equivalents, and marketable securities. Sauvage said $50 million remains available under a term loan agreement with Sagard Healthcare Partners through June 30, and the company expects a milestone payment of approximately $30 million from ASI upon Ibtrozi approval in Europe in the first half of 2027.
On gross-to-net dynamics, Sauvage said the company saw an “expected uptick” at the start of the year and expects gross-to-net expansion to “gradually stabilize,” later indicating it could stabilize “around” 30% based on launch dynamics and inflation-related mechanics.
Pipeline updates: safusidenib and development plans
Hung said Nuvation remains “very excited” about safusidenib for IDH1 mutant glioma. He described the ongoing Phase III SIGMA trial evaluating safusidenib as maintenance treatment for patients with IDH1 mutant astrocytoma with high-risk features following standard of care, along with a non-pivotal cohort in Grade 3 oligodendroglioma following surgery. Hung said prior Phase I and Phase II single-arm studies have shown “durable responses and prolonged progression-free survival” across low- and high-grade IDH1 mutant gliomas.
He also highlighted a Neuro-Oncology publication from November 2025 summarizing a Phase II study in chemotherapy- and radiotherapy-naive Grade 2 IDH1 glioma patients, noting that as of February 2026, 12 of 27 patients remained on treatment with a median follow-up of more than five years.
In April, Nuvation acquired exclusive rights to safusidenib in Japan from Daiichi Sankyo. Hung said the company plans to expand the SIGMA Phase III trial into Japan and pursue additional presentation and publication of longer-term Phase II data.
During Q&A, Hung said SIGMA is placebo-controlled and described current high-grade glioma standard of care as surgery, radiation, and chemotherapy, adding that response rates are “very low.” He said the company would view “anything north of 20%” response rate as potentially meaningful for discussions with the FDA in settings with no approved therapies.
Looking ahead, Hung said the company plans to present additional TRUST data at ASCO in June, including patient-reported outcomes and information from the TRUST-IV adjuvant study, and said Nuvation remains on track to provide an update on its drug-drug conjugate platform 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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