Nuvation Bio Inc.

Updated label reflects TRUST-I TKI-naïve median duration of response of nearly 50 months No changes to the safety sections of labeling with longer follow-up and no new safety signals identified Approval comes four months ahead of PDUFA date NEW YORK, Sept. 16, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for IBTROZI® (taletrectinib), a ROS1 inhibitor approved for the treatment of locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC).

Nuvation Bio Inc. (NUVB) Presents at 12th Annual Cantor Fitzgerald Global Healthcare Conference Transcript

Long-term pooled data from the pivotal TRUST-I and TRUST-II studies showed similar efficacy, including duration of response and progression-free survival, between CD74 and non-CD74 ROS1 fusion-partner subgroups Among patients who received IBTROZI after prior chemotherapy, response rates remained consistent, offering reassurance for patients who begin chemotherapy before a ROS1 fusion is identified NEW YORK, Sept. 15, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced new subgroup analyses from the pivotal TRUST-I and TRUST-II studies evaluating IBTROZI® (taletrectinib) in both TKI- naïve and TKI-pretreated patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC).

Nuvation Bio Inc. (NUVB) Presents at Citigroup's Biopharma Back to School Summit 2026 Transcript