NUVB News & Events

Nuvation Bio announced the company has amended its existing exclusive license agreement for safusidenib with Daiichi Sankyo to include Japan rights, effectively securing exclusive global development and commercialization rights of the investigational medicine. The agreement, as amended, enables Nuvation Bio to expand its ongoing pivotal SIGMA study of safusidenib into Japan, and provides rights to all previously generated and future data to support further publication of safusidenib results in IDH1-mutant glioma. Safusidenib is a novel, oral, potent, brain-penetrant, selective inhibitor of mutant IDH1 that is currently being evaluated in the ongoing Phase 3 SIGMA study for the maintenance treatment of patients with IDH1-mutant astrocytoma who have high-risk features following standard-of-care. In Phase 1 and Phase 2 single arm studies, safusidenib has shown encouraging efficacy signals across all IDH1-mutant glioma grades and treatment lines, including durable responses and prolonged progression-free survival that show tumor shrinkage and disease control.

Nuvation Bio (NUVB) and Eisai Co. (ESAIY) announced that the European Medicines Agency, or EMA, has validated the Marketing Authorisation Application, or MAA, for taletrectinib for the treatment of advanced ROS1-positive non-small cell lung cancer, or NSCLC. The filing will follow a standard review timeline. In January, Eisai and Nuvation Bio announced they had entered into an exclusive licensing and collaboration agreement in Europe and additional countries outside the U.S., China and Japan to extend the global reach of taletrectinib. Following this filing to the EMA, additional filings are planned for the U.K., Canada and other regions included in Eisai's licensed territories. The application is based on data from the two pivotal Phase 2 clinical studies, TRUST-I and TRUST-II, evaluating taletrectinib in patients globally. The accepted MAA will be considered to support full approval. In June 2025, the FDA granted full approval to taletrectinib for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy. Taletrectinib is also approved for patients with advanced ROS1+ NSCLC in Japan and in China.

Nuvation Bio is down -25.3%, or -$1.48 to $4.36.

Nuvation Bio is down -25.3%, or -$1.48 to $4.36.