FDA approves Nuvation Bio IBTROZI sNDA, NUVB jumps 6%
The FDA approved Nuvation Bio’s supplemental New Drug Application for IBTROZI (taletrectinib), updating the label for the ROS1 inhibitor ahead of the PDUFA target date. NUVB shares rose more than 6% to $6.130.
S. ’s supplemental New Drug Application for IBTROZI (taletrectinib) on Thursday, and the stock rose more than 6%. The approval came four months before the PDUFA date. The agency updated the label for the ROS1 inhibitor, which is used to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC), to highlight a longer median duration of response.
7 months for TKI-naïve patients in the TRUST-I clinical trial. The company said the result reflects more than four years of sustained clinical benefit for patients. The regulatory update also said the drug’s safety profile remains unchanged. The extended follow-up period found no new safety signals, and the safety sections of the labeling were left unchanged.
The supplemental application includes a 51-month median follow-up from the TRUST-I trial and adds 14 months of data from the TRUST-I and TRUST-II studies as of August 2025. Nuvation Bio said taletrectinib originally received full approval in June 2025. The drug is also approved in Japan and China, where Nippon Kayaku and Innovent Biologics market it, respectively. The company said it and partner Eisai are continuing to expand the therapy’s regulatory reach globally.
The European Medicines Agency validated the Marketing Authorization Application (MAA) for taletrectinib in March 2026, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency validated the MAA in June 2026. 130 at the time of publication on Thursday, according to Pro data.