NUVB News & Events

Nuvation Bio announced new patient-reported outcomes data from the pivotal TRUST-II study of Ibtrozi - taletrectinib - in patients with advanced ROS1-positive non-small cell lung cancer, or NSCLC. The new data will be presented on May 31 at the ASCO Annual Meeting 2026. TRUST-II is a global Phase 2 study evaluating the safety and efficacy of IBTROZI in patients with advanced ROS1+ NSCLC. Mean changes from baseline improved or remained stable for most domains across both questionnaires. Quality-of-life and cognitive function scores improved from baseline or remained stable over time in both TKI-naive and TKI-pretreated patients. At the first assessment, 88% of patients reported improved or stable global health quality-of-life scores. The majority of patients in both subgroups improved or remained stable across subsequent time points throughout treatment. 84-96% of patients reported improved or stable scores for coughing and shortness of breath, and these improvements were sustained through eight months of treatment. In May 2026, the FDA accepted a supplemental New Drug Application with updated data for Ibtrozi with a target action date of January 4, 2027.

Nuvation Bio (NUVB) announced the completion of process tech transfer and product introduction to Thermo Fisher (TMO) for Ibtrozi - taletrectinib - to treat advanced or metastatic ROS1-positive non-small cell lung cancer, or NSCLC. The transition was submitted as a supplement to the IBTROZI New Drug Application held by Nuvation Bio and is now complete.

Nuvation Bio announced that the U.S. FDA has accepted a supplemental New Drug Application with updated data for IBTROZI in both TKI-naive and TKI-pretreated advanced ROS1-positive non-small cell lung cancer with a target action date of January 4, 2027.

Reports Q1 revenue $83.23M, consensus $62.34M. "We are pleased with IBTROZI's ongoing launch trends in the first quarter of 2026, as we continue to deepen its adoption across lines of therapy and make significant progress in becoming the standard of care for people living with advanced ROS1-positive NSCLC. The newly updated long-term follow-up data from our pivotal studies presented at AACR demonstrated an unprecedented durability for IBTROZI of now more than four years in TKI-naive patients, further supporting healthcare providers and their patients' confidence in selecting IBTROZI. With our partners, we are well on our way to bringing this important medicine to patients in need around the world," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We are also thrilled to have secured exclusive global development and commercialization rights to safusidenib. We look forward to advancing the pivotal Phase 3 SIGMA study for patients with high-risk IDH1-mutant glioma, where targeted treatment options are incredibly limited. Additionally, we are well on track to provide updates on our drug-drug conjugate platform later this year as we further our mission to tackle some of the toughest challenges in cancer treatment."