Rolling NDA Submission

Nuvalent has initiated a rolling NDA submission to the FDA for zidesamtinib, a ROS1-selective inhibitor, for advanced ROS1-positive NSCLC patients previously treated with TKIs. The submission is supported by pivotal data from the ARROS-1 trial presented at WCLC 2025. Zidesamtinib has been granted RTOR designation, potentially accelerating its review. The drug is designed to overcome resistance mutations and improve treatment of brain metastases. Completion of the rolling submission is expected in Q3 2025. Nuvalent is also in discussion with the FDA regarding potential expansion of indications.