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NUVB 資訊
NUVB 事件
Vir Biotechnology Appoints Dr. David Liu as Chief Medical Officer
Vir Biotechnology (VIR) announced the appointment of David Liu, M.D., Ph.D., as Executive Vice President and Chief Medical Officer, effective October 12, 2026. Dr. Liu will be responsible for leading the clinical development, medical affairs and regulatory affairs functions. Liu joins Vir Biotechnology from Nuvation Bio (NUVB), where he served as CMO.
Nuvation Bio's Ibtrozi Approved by FDA
Nuvation Bio announced that the U.S. FDA has approved a supplemental New Drug Application for Ibtrozi, a ROS1 inhibitor approved for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer. The updated Ibtrozi label now reflects updated median duration of response for the TRUST-I study, with a median DOR of 49.7 months in TKI-naive patients in TRUST-I, reflecting more than four years of sustained clinical benefit. This update came with no changes to the safety sections of labeling, with no new signals identified with longer follow-up, confirming the safety profile.
Nuvation Bio Releases New Data on Ibtrozi Showing Consistent Efficacy
Nuvation Bio announced new subgroup analyses from the pivotal TRUST-I and TRUST-II studies evaluating Ibtrozi - taletrectinib - in both TKI- naive and TKI-pretreated patients with advanced ROS1-positive non-small cell lung cancer, or ROS1+ NSCLC. The data, presented at the IASLC 2026 World Conference on Lung Cancer in Seoul, demonstrated that Ibtrozi delivered consistent efficacy regardless of prior chemotherapy exposure or ROS1 fusion partner, providing additional evidence supporting its use across a broad range of patients with advanced ROS1+ NSCLC. Previously at AACR 2026, the pooled analysis of all TKI-naive patients in the TRUST-I and TRUST-II studies presented showed a confirmed objective response rate of 89.8% and a median duration of response of 49.7 months. At WCLC, one of the new analyses presented in the poster revealed consistent response rates regardless of prior chemotherapy exposure. Additionally, both TKI-naive and TKI-pretreated patients consistently benefited from Ibtrozi regardless of ROS1 fusion partner. The FDA approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC in June 2025.
Nuvation Bio Receives FDA Fast Track Designation
Nuvation Bio announced that the FDA has granted Fast Track Designation for safusidenib, the company's investigational, oral, brain-penetrant selective inhibitor of mutant IDH1. The designation was granted based on favorable data from the safusidenib clinical program to date. Most recently, Nuvation Bio announced updated data from the Phase 2 J201 study demonstrating durable responses and a favorable risk-benefit profile over long-term follow-up. No new safety signals have been identified with longer-term follow-up.
Nuvation Bio Q2 Revenue $31.7M Beats Expectations
Reports Q2 revenue $31.7M, consensus $27.47M. "IBTROZI is now the most prescribed ROS1 TKI in both first-line and overall new patient starts in 2026, based on IQVIA claims data from the first five months of the year, reflecting the medical community's growing conviction that IBTROZI's durability profile belongs at the front of the treatment sequence. Consistent with this, approximately 85% of new prescriptions this quarter were for TKI-naive patients who have the potential to be on therapy for many years. The continued shift toward TKI-naive use highlights the increasing recognition of our long-term follow-up data in TRUST-I, which show a confirmed 90% response rate and a median duration of response of 50 months," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "This efficacy profile, combined with a generally tolerable safety profile and as the only brain-penetrant ROS1 inhibitor today without a CNS warning and precaution in its label, reinforces our belief that IBTROZI is becoming the standard of care for patients with advanced ROS1-positive NSCLC." Dr. Hung continued, "We are equally excited about the progress of safusidenib, with our updated Phase 2 data showing further deepening and durable responses in IDH1-mutant gliomas. We now plan to evaluate the potential of this investigational medicine across the broad spectrum of patients in hopes of fulfilling our ultimate goal of providing an effective therapy for nearly every patient with this disease. During the second quarter, we also strengthened our balance sheet through our convertible notes offering, providing us with the financial flexibility to continue to invest in growing our portfolio."
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