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Nuvalent Highlights Pipeline Progress, Anticipates 2029 Operating Runway.
ByAinvest
Monday, Jan 12, 2026 6:34 am ET1min read
NUVL--
Nuvalent, a biopharmaceutical company, has announced FDA acceptance of its NDA for zidesamtinib for TKI pre-treated patients with advanced ROS1-positive NSCLC, with a PDUFA target action date of September 18, 2026. The company plans NDA submissions for neladalkib in TKI pre-treated ALK-positive NSCLC and zidesamtinib expansion in TKI-naïve ROS1-positive NSCLC populations in 2026. Nuvalent remains well capitalized with an operating runway into 2029.
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