Zidesamtinib (NVL-520) is a Nuvalent Inc. program in ROS1 Non-small cell lung cancer (NSCLC). The FDA approved it on Jul 22, 2026. 1 FDA decision on record below. Every date links its source.
Zidesamtinib (NVL-520) is marketed as JIDEYTRO (zidesamtinib); the events below include those tracked under the brand name. Indication under review: ROS1 Non-small cell lung cancer (NSCLC). Sponsor: Nuvalent Inc. (NUVL). Market-cap tier at the time we tracked it: Mid. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
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