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Zidesamtinib (NVL-520)

TKI pre-treated advanced ROS1+ NSCLC

Phase 2PDUFA target action 2H 2026NCT05118789

Key Facts

Indication
TKI pre-treated advanced ROS1+ NSCLC
Phase
Phase 2
Status
PDUFA target action 2H 2026
Company

About Nuvalent

Nuvalent leverages deep expertise in chemistry and structure-based drug discovery to create precisely targeted therapies that address the dual challenges of kinase resistance and selectivity in oncology. The company's lead programs include zidesamtinib (NVL-520) for ROS1+ NSCLC with PDUFA target action in 2H 2026, and neladalkib (NVL-655) for ALK+ NSCLC currently in Phase 3 trials. With a robust pipeline targeting validated kinase targets and a strong commercial organization, Nuvalent is positioned to deliver durable responses for cancer patients with limited treatment options.

View full company profile

About Nuvalent

Nuvalent leverages deep expertise in chemistry and structure-based drug discovery to create precisely targeted therapies that address the dual challenges of kinase resistance and selectivity in oncology. The company's lead programs include zidesamtinib (NVL-520) for ROS1+ NSCLC with PDUFA target action in 2H 2026, and neladalkib (NVL-655) for ALK+ NSCLC currently in Phase 3 trials. With a robust pipeline targeting validated kinase targets and a strong commercial organization, Nuvalent is positioned to deliver durable responses for cancer patients with limited treatment options.

View full company profile

About Nuvalent

Nuvalent leverages deep expertise in chemistry and structure-based drug discovery to create precisely targeted therapies that address the dual challenges of kinase resistance and selectivity in oncology. The company's lead programs include zidesamtinib (NVL-520) for ROS1+ NSCLC with PDUFA target action in 2H 2026, and neladalkib (NVL-655) for ALK+ NSCLC currently in Phase 3 trials. With a robust pipeline targeting validated kinase targets and a strong commercial organization, Nuvalent is positioned to deliver durable responses for cancer patients with limited treatment options.

View full company profile