Nuvalent (NUVL)

Executive Summary

Nuvalent is a precision oncology company focused on developing brain-penetrant kinase inhibitors for ROS1, ALK, and HER2-driven cancers. Its pipeline includes three clinical-stage assets: NVL-655 (neladalkib) for ALK-positive non-small cell lung cancer (NSCLC), currently in Phase 1/2 and a Phase 3 combination trial with alectinib; NVL-520 (zidesamtinib) for ROS1-positive NSCLC, in Phase 1/2; and NVL-330 for HER2-altered solid tumors, in Phase 1. The company's structure-based approach aims to overcome resistance and achieve durable responses, with all compounds designed to penetrate the brain, addressing a high unmet need in CNS metastases. Recent data from NVL-655 and NVL-520 have shown promising efficacy and safety in heavily pretreated patients, supporting their potential as best-in-class therapies. With a strong cash position and advancing trials, Nuvalent is positioned for multiple value-driving milestones in the coming years.

Upcoming Catalysts (preview)

• Q3 2026NVL-655 (neladalkib) Phase 1/2 monotherapy data update for ALK-positive NSCLC85% success
• H2 2026NVL-520 (zidesamtinib) Phase 1/2 data for ROS1-positive NSCLC, including activity in resistant mutations80% success
• Q4 2026NVL-330 Phase 1 initial safety and efficacy data for HER2-mutant solid tumors60% success