05:09 PM EST, 11/19/2025 (MT Newswires) -- Nuvalent ( NUVL ) said the US Food and Drug Administration accepted the company's new drug application for zidesamtinib to treat adults with advanced ROS1-positive non-small cell lung cancer who have previously received at least one ROS1 tyrosine kinase inhibitor

The agency set a Sept. 18 target action date, Nuvalent ( NUVL ) said Wednesday in a statement.

Nuvalent ( NUVL ) shares fell 1.1% in after-hours trading.