FDA Clears Nuvalent's Zidesamtinib NDA For Advanced ROS1-Positive Lung Cancer Treatment

Nuvalent, Inc. (NUVL) revealed that U.S. regulators have accepted its New Drug Application submission for zidesamtinib, marking a significant milestone for the biotech firm’s pipeline. The drug is being developed as a targeted therapy for adult patients diagnosed with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have already received at least one prior ROS1 tyrosine kinase inhibitor (TKI).

Regulatory Timeline and Clinical Data Foundation

The FDA’s acceptance carries a Prescription Drug User Fee Act (PDUFA) target review date set for September 18, 2026. This clearance decision is anchored by clinical evidence from the ARROS-1 Phase 1/2 trial (NCT05118789), a first-in-human study examining the investigational compound across patients with advanced ROS1-positive NSCLC and other solid tumors. The trial data demonstrating efficacy in treatment-experienced patients provided the foundation for the regulatory filing.

Market Response and Stock Performance

Following the announcement, Nuvalent’s equity showed immediate positive momentum during regular market hours, with shares closing Wednesday’s session at $107.13, representing a gain of $2.89 or approximately 2.77%. However, the enthusiasm moderated in after-hours electronic trading, where NUVL declined by $2.13, or roughly 1.99%, suggesting profit-taking among early movers.

The acceptance of zidesamtinib’s NDA represents a potential expansion opportunity in the ROS1 inhibitor space, particularly for patients who have experienced resistance or intolerance to existing kinase inhibitor therapies.