Nuvalent Announces FDA Acceptance of Zidesamtinib NDA for ROS1-Positive NSCLC.

Nuvalent has announced progress in its OnTarget 2026 operating plan, including an FDA acceptance of its NDA for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC patients. The PDUFA target action date is September 18, 2026. The company plans to submit an NDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC patients in the first half of 2026 and a potential indication expansion of zidesamtinib in TKI-naïve advanced ROS1-positive NSCLC patients in the second half of 2026. Nuvalent is well capitalized with an operating runway anticipated into 2029.