Zidesamtinib (NVL-520)
TKI pre-treated advanced ROS1+ NSCLC
Key Facts
About Nuvalent
Nuvalent is a $7.69 billion precision oncology company developing next-generation, brain-penetrant kinase inhibitors to address the dual challenges of treatment resistance and poor CNS activity in cancers driven by ROS1, ALK, and HER2. The company has advanced two lead assets into pivotal studies: zidesamtinib (NVL-520) for ROS1+ NSCLC with a PDUFA target in 2H 2026, and neladalkib (NVL-655) for ALK+ NSCLC, which is in a Phase 3 head-to-head trial against alectinib. Nuvalent's strategy leverages deep structure-based drug design to create therapies with optimized selectivity profiles, aiming to improve durability of response and outcomes for patients with limited treatment options.
View full company profileAbout Nuvalent
Nuvalent is a $7.69 billion precision oncology company developing next-generation, brain-penetrant kinase inhibitors to address the dual challenges of treatment resistance and poor CNS activity in cancers driven by ROS1, ALK, and HER2. The company has advanced two lead assets into pivotal studies: zidesamtinib (NVL-520) for ROS1+ NSCLC with a PDUFA target in 2H 2026, and neladalkib (NVL-655) for ALK+ NSCLC, which is in a Phase 3 head-to-head trial against alectinib. Nuvalent's strategy leverages deep structure-based drug design to create therapies with optimized selectivity profiles, aiming to improve durability of response and outcomes for patients with limited treatment options.
View full company profileAbout Nuvalent
Nuvalent is a $7.69 billion precision oncology company developing next-generation, brain-penetrant kinase inhibitors to address the dual challenges of treatment resistance and poor CNS activity in cancers driven by ROS1, ALK, and HER2. The company has advanced two lead assets into pivotal studies: zidesamtinib (NVL-520) for ROS1+ NSCLC with a PDUFA target in 2H 2026, and neladalkib (NVL-655) for ALK+ NSCLC, which is in a Phase 3 head-to-head trial against alectinib. Nuvalent's strategy leverages deep structure-based drug design to create therapies with optimized selectivity profiles, aiming to improve durability of response and outcomes for patients with limited treatment options.
View full company profile