Crizotinib

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, 2025 Company to present at 44 th Annual J.P. Morgan Healthcare Conference tomorrow, January 13, at 3:45 p.m. PT/6:45 p.m. ET NEW YORK--(BUSINESS WIRE)--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 44 th Annual J.P. Morgan Healthcare Conference in San Francisco, CA . Preliminary Fourth Quarter and Full Year 2025 Financial Results and IBTROZI Commercial Results In the third quarter, the company’s first full quarter of sales, 204 new patients started treatment on IBTROZI for advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) In the fourth quarter, 216 new patients started treatment on IBTROZI for advanced ROS1+ NSCLC, exceeding internal projections and in spite of the holiday-adjacent weeks where new patient starts can be limited in this rare disease With 432 new patients started since launch in the second half of June, the treatment adoption rate is approximately six times greater than that of prior recent ROS1 tyrosine kinase inhibitor (TKI) launches based on IQVIA data Preliminary fourth quarter and full year 2025 IBTROZI net product revenue was $15.7 million and $24.7 million, respectively Received $25 million milestone payment from Nippon Kayaku as a result of establishment of the reimbursement price in Japan in Q4 Preliminary unaudited cash, cash equivalents and marketable securities are expected to be approximately $529.2 million as of December 31, 2025 2026 Priorities and Upcoming Milestones Continue to grow IBTROZI new patient starts in advanced ROS1+ NSCLC, particularly in the first-line setting, while supporting continuity of therapy for current patients to achieve maximum potential benefits Entered exclusive license and collaboration agreement with Eisai Co., Ltd. on January 11, 2026 to develop, register and commercialize taletrectinib for the treatment of ROS1+ NSCLC in Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam and India Advance the pipeline, including: Continue enrollment of G203 as a phase 3, registration-enabling study evaluating safusidenib in high-grade and high-risk IDH1 -mutant gliomas Ongoing evaluation of preclinical candidates from our drug-drug conjugate (DDC) platform Pursue business development opportunities to expand the pipeline and further our mission of tackling some of the toughest challenges in cancer treatment Maintain a robust cash position and strong balance sheet that can support continued investment in future growth “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 urgency.” 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 44 th 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. About ROS1+ NSCLC Each 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. About IBTROZI 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-naïve 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. Indication IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC). IMPORTANT SAFETY 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. ADVERSE REACTIONS 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%). ​ DRUG INTERACTIONS Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use. Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI. OTHER CONSIDERATIONS Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity. ​ Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose. Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible. Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established. Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation. Please see accompanying full Prescribing Information . About Nuvation Bio 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 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 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 contained in this press release. Contacts Media and Investor Contacts Nuvation Bio Investor Contact JR DeVita ir@nuvationbio.com Nuvation Bio Media Contact Kaitlyn Nealy media@nuvationbio.com

SOUTH SAN FRANCISCO, Calif., Jan. 11, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, provided a business update including an overview of key corporate objectives for 2026. The company will review these updates during its presentation at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026 at 3:45pm PST. "2025 was a year of execution, marked by broad pipeline advancement, commercial readiness activities for darovasertib, and the filing of four INDs resulting in nine clinical programs. Our deep pipeline and cash runway into 2030 enable IDEAYA to advance key combinations and to address multiple indications with high unmet need, including uveal melanoma, small cell lung cancer, neuroendocrine cancer, breast cancer, and MTAP-deleted lung, pancreatic, and urothelial cancers. In 2026, we plan to advance four registrational trials, including for IDE849, our Phase 1 DLL3 TOP1 ADC, as a monotherapy agent in neuroendocrine cancer, and darovasertib in both pre-metastatic and metastatic settings of uveal melanoma. These trials for darovasertib are central to our strategy to save eyes, preserve vision, and extend lives for patients with uveal melanoma - one of the poorest prognosis indications in oncology where the majority of patients have no available FDA approved therapies," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences. 2026 Corporate Objectives Darovasertib in uveal melanoma (UM) Topline results, including progression free survival (PFS) data, from ongoing registrational Phase 2/3 OptimUM-02 trial of the darovasertib and crizotinib combination in first line (1L) patients with HLA*A2-negative metastatic UM (mUM) are expected in Q1 '26 Randomized PFS analysis is based on the first 130 PFS events from the intent-to-treat population (ITT) enrolled in the Phase 2b/3 portion of the trial, which comprises approximately 313 patients randomized 2:1 to the treatment versus control arm. The topline PFS results, if positive, are anticipated to enable a potential accelerated approval filing in the United States Darovasertib is anticipated to be in three randomized, Phase 3 registrational trials across all stages of uveal melanoma by H1 '26 OptimUM-02 (mUM): full enrollment of 437 patients complete; overall survival (OS) data expected to support a filing for full approval in 1L HLA*A2-negative mUM OptimUM-10 (neoadjuvant): complete full enrollment of approximately 450 patients across enucleation and plaque brachytherapy cohorts by H1 '27 OptimUM-11 (adjuvant): initiate trial in collaboration with Servier in Q2 '26 Complete enrollment of approximately 80 HLA*A2-positive mUM patients in ongoing single-arm, Phase 2 OptimUM-01 trial of darovasertib in combination with crizotinib by Q2 '26; data to support a potential real world evidence (RWE) submission to the U.S. Food and Drug Administration (FDA) and/or NCCN/compendia listing in this patient subset Antibody-drug Conjugate (ADC) + DNA damage response (DDR) combinations IDE849 (DLL3 TOP1 ADC): target to initiate a monotherapy registrational study in the second line/refractory setting (2L+) of small cell lung cancer (SCLC) and/or neuroendocrine carcinomas (NEC) by the end of 2026 IDE034 (B7H3/PTK7 bispecific TOP1 ADC): initiate Phase 1 dose escalation trial in Q1 '26 IDE161 (PARG): initiate clinical combination studies with IDE849 in SCLC, NEC and other DLL3-overexpressing solid tumors in Q2 '26 MTAP Pathway IDE397 (MAT2A): provide updated data from Phase 1/2 combination trial with Trodelvy in MTAP-deleted urothelial cancer (UC) at a medical conference in 2026 IDE892 (PRMT5): initiate a Phase 1 monotherapy dose escalation trial in Q1 '26 to enable a combination trial with IDE397 in MTAP-deleted non-small cell lung cancer (NSCLC) in Q2 '26 Submit an investigational new drug (IND) application for a potential first-in-class program targeting CDKN2A, the most common co-alteration of MTAP, by the end of 2026. With the CDKN2A candidate, IDEAYA plans to enable wholly owned combinations with IDE892 and IDE397 in MTAP-deleted non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and with IDE574, IDEAYA's dual KAT6/7 inhibitor Next Generation Therapies IDE574 (KAT6/7): obtained clearance of an IND application with the U.S. FDA in January 2026; target to initiate Phase 1 dose escalation trial in Q1 '26 Corporate ~$1.1 billion in cash, cash equivalents and marketable securities as of 9/30/25; expected to fund current operating plan into 2030 Darovasertib commercial readiness activities advancing in the United States and globally with their partner, Servier IDEAYA's updated corporate presentation reflecting its 2026 corporate guidance is available on its website under the Investor Relations section: . About IDEAYA Biosciences IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer. Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to: i) the potential therapeutic benefits of IDEAYA therapeutics; (ii) the timing and content of clinical program updates, regulatory updates and clinical trial data readouts, including those at medical conferences; (iii) the potential and timing for an accelerated approval filing for darovasertib; (iv) the timing of darovasertib in three Phase 3 registrational trials across all stages of UM; (v) the utilization of OS data to support a potential full approval filing for darovasertib; (vi) the timing of initiating registrational studies and other clinical trials for IDEAYA therapeutics; (vii) the timing of patient enrollments in clinical trials; (viii) the timing of IND submissions for IDEAYA therapeutics; and (iv) the extent to which IDEAYA's existing cash, cash equivalents, and marketable securities will fund its current operating plan. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's current and future filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K filed on February 18, 2025. Investor and Media Contact IDEAYA Biosciences Joshua Bleharski, Ph.D. Chief Financial Officer [email protected] SOURCE IDEAYA Biosciences, Inc. 21% more press release views with Request a Demo