Nuvalent progressing with OnTarget 2026 plan for zidesamtinib, with FDA NDA accepted; PDUFA target action date set for Sept 18, 2026 and neladalkib NDA submission planned for first half 2026.
The FDA has approved the New Drug Application (NDA) for zidesamtinib to treat advanced ROS1-positive NSCLC patients who have previously undergone TKI treatment. The Prescription Drug User Fee Act (PDUFA) target action date for this drug is September 18, 2026. Furthermore, an NDA submission for neladalkib, intended for the TKI pre-treated advanced ALK-positive NSCLC population, is scheduled for the first half of 2026.
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