Nuvalent, Inc. (NUVL) announced that the U.S. Food and Drug Administration 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 1 prior ROS1 tyrosine kinase inhibitor (TKI). The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Nuvalent's NDA submission is based on results for TKI pre-treated patients with advanced ROS1-positive NSCLC enrolled in the global registrational ARROS-1 Phase 1/2 clinical trial.
Zidesamtinib is currently being investigated in the ARROS-1 trial (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced ROS1-positive NSCLC and other solid tumors.
NUVL closed Wednesday's regular trading at $107.13, up $2.89 or 2.77%. But in after-hours trading, the stock dropped $2.13 or 1.99%.
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