Nuvalent Inc. (NUVL) announced that its New Drug Application seeking approval of Zidesamtinib for treating adult patients with advanced ROS1-positive non-small cell lung cancer has been accepted for review by the FDA and assigned a decision date of September 18, 2026.
Zidesamtinib is an investigational, novel, brain-penetrant ROS1-selective inhibitor designed to overcome limitations of currently available ROS1 therapies. It is designed to remain active in tumors that have developed resistance, including those with treatment-emergent ROS1 mutations such as G2032R.
The drug is also engineered for central nervous system (CNS) penetrance to improve outcomes for patients with brain metastases, while avoiding inhibition of the related TRK family to reduce CNS adverse events.
The NDA submission is supported by data from the global registrational ARROS-1 Phase 1/2 clinical trial. In the Phase 1 portion, zidesamtinib was evaluated for safety, tolerability, pharmacokinetics and preliminary anti-tumor activity in ROS1-positive NSCLC and other solid tumors.
The ongoing Phase 2 portion, designed with registrational intent, is assessing efficacy in both TKI-naïve and TKI-pretreated patients.
Zidesamtinib has already received breakthrough therapy designation for ROS1-positive metastatic NSCLC in patients previously treated with two or more ROS1 TKIs, as well as orphan drug designation for ROS1-positive NSCLC.
NUVL has traded in the range of $55.53 to $112.53 over the past year. The stock closed yesterday's trading at $107.13, up 2.77%.
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