Nuvalent, Inc. has started the rolling submission of a New Drug Application (NDA) for zidesamtinib, intended for TKI pre-treated advanced ROS1-positive NSCLC patients. This initiative falls under the FDA's RTOR program and is expected to be finalized by the third quarter of 2025. The company is based in CAMBRIDGE, Mass., and the announcement was made on September 7, 2025. Nuvalent, Inc. is listed on Nasdaq under the ticker symbol NUVL.