Full Press Release Details
Nuvation Bio Reports Preliminary Fourth Quarter and Full Year 2025 Financial Results and Provides 2026
Outlook Ahead of 44th Annual J.P. Morgan Healthcare Conference
Successfully started 216 patients on IBTROZI (taletrectinib) in the fourth quarter of 2025, for a total of 432 new patient starts since launch in the second half of June 2025
Preliminary IBTROZI net product revenue of approximately $15.7 million in the fourth quarter and $24.7 million since launch
Preliminary unaudited cash, cash equivalents and marketable securities of approximately $529.2 million as of December 31,
Company to present at 44th Annual J.P. Morgan Healthcare
Conference tomorrow, January 13, at 3:45 p.m. PT/6:45 p.m. ET
NEW YORK-January 12, 2026- 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
Preliminary Fourth Quarter and Full Year 2025 Financial Results and IBTROZI Commercial Results
2026 Priorities and Upcoming Milestones
"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
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.
J.P. Morgan Healthcare Conference Presentation and Webcast
David Hung, M.D. will present at the 44th Annual J.P. Morgan Healthcare Conference tomorrow, Tuesday,
January 13, 2026, at 3:45 p.m. PT (6:45 p.m. ET) in San Francisco, CA. A live webcast of the presentation will be available on the Investor Relations section of the Nuvation Bio website. An archived recording will be available for 30
days following the event.
year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+
disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central
nervous system (CNS) metastases.
IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025,
following Priority Review and Breakthrough Therapy designations for both TKI-na ve and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved IBTROZI for the treatment of adult patients with locally advanced or metastatic
ROS1+ NSCLC. Learn more at IBTROZI.com.
About the TRUST Clinical Program
The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of IBTROZI.
TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating IBTROZI for the
treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in
the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring
TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating IBTROZI versus crizotinib in 138 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs.
IBTROZI is indicated for the treatment of
adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).
INFORMATION FOR IBTROZI (taletrectinib)
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased
AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).
Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was
caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients.
Concurrent elevations in AST or ALT 3 times the
ULN and total bilirubin 2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.
Interstitial Lung Disease
(ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time
to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months).
ILD/pneumonitis led to dose interruption in 1.1% of patients, dose
reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients.
QTc Interval Prolongation: QTc interval prolongation
can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.
In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec
occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade 3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction
each occurred in 2.8% of patients.
Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A
inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.
Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade 3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.
Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of
patients. Median time to first onset was 11 days (range: 2 days to 10 months).
Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.
Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures.
3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption
occurred in 0.3% of patients.
Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can
cause fetal harm when administered to a pregnant woman.
Among patients who received IBTROZI, the most frequently reported adverse reactions ( 20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness
(22%), rash (22%), constipation (21%), and fatigue (20%).
The most frequently reported Grade 3/4 laboratory abnormalities ( 5%) were increased ALT
(13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).
OTHER CONSIDERATIONS
Please see accompanying full Prescribing Information.
Nuvation Bio is a global oncology
company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib (IBTROZI ), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; NUV-868, a BD2-selective BET
inhibitor; and an innovative drug-drug conjugate (DDC) program.
Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who
previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit
www.nuvationbio.com or follow the company on LinkedIn and X (@nuvationbioinc).
Forward-Looking Statements
The preliminary financial results presented herein are estimates and subject to the completion of the Company's financial closing and other procedures
and finalization of the Company's consolidated financial statements for its quarter ended December 31, 2025 and for its full year 2025, and subsequent events may occur that require adjustments to these results. These preliminary
financial results have not been reviewed by the Company's independent auditors. Accordingly, actual financial and operating results that will be reflected in the Company's Annual Report on Form
10-K for the quarter ended December 31, 2025 and for the full year 2025, including in its financial statements, may differ materially from these preliminary results. In addition, any statements regarding
the Company's estimated financial results for the quarter ended December 31, 2025 and for the full year 2025 included herein do not present all information necessary for an understanding of the Company's financial condition and
results of operations as of and for the quarter ended December 31, 2025 and for full year 2025.
Certain statements included in this press release
that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as
"believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan,"
"predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical
matters. These forward-looking statements include, but are not limited to, statements about IBTROZI and safusidenib's therapeutic and commercial potential, our 2026 corporate priorities and upcoming milestones, IBTROZI becoming the new
standard of care in advanced ROS1+ NSCLC across treatment lines, and the need for new therapeutic options in IDH1-mutant gliomas. These statements are based on various assumptions, whether or not identified in this press release, and on the current
expectations of the management team
of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from
those anticipated by the forward-looking statements, including but not limited to whether Nuvation Bio is successful in commercializing IBTROZI; the challenges associated with conducting drug discovery and initiating or conducting clinical studies
due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with
preliminary and interim data, which may not be representative of more mature data; whether Nuvation Bio meets its post-marketing requirements and commitments for IBTROZI; and competitive developments. Risks and uncertainties facing Nuvation Bio are
described more fully in its Form 10-Q filed with the SEC on November 3, 2025 under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. You
are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements