Clinical-stage biopharmaceutical company Nuvalent Inc (Nasdaq:NUVL) said on Wednesday that the US Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for zidesamtinib, an investigational ROS1-selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least one prior ROS1 tyrosine kinase inhibitor (TKI).

The Prescription Drug User Fee Act (PDUFA) target action date for the application is 18 September 2026.

Nuvalent's NDA submission is based on results in TKI pre-treated patients with advanced ROS1-positive NSCLC enrolled in the global registrational ARROS-1 Phase 1/2 clinical trial. These data were reported along with preliminary data from the ongoing Phase 2 TKI-naive cohort of ARROS-1, and presented as part of the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer in September 2025.

Zidesamtinib is an investigational, novel brain-penetrant ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors.