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Nuvalent Details Strategy to Seek First Potential Approval in 2026 and Outlines Key Anticipated 2025 Milestones
NUVLNuvalent(NUVL) Prnewswire·2025-01-13 11:30

Strategy prioritizes most accelerated path to first potential approval  Initial NDA submission expected by mid-year for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population, with topline pivotal data anticipated in the first half of 2025 Topline pivotal data for neladalkib (NVL-655) in TKI pre-treated ALK-positive NSCLC population anticipated by year-end 2025 Company to present at 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14th at 9:00 a.m. PT CAMBRIDGE, Mass., Jan. 13, 2025 ...