Nuvalent Plans Initial NDA Submission for Zidesamtinib by Mid-2025 and Reports Pivotal Data Milestones

Nuvalent, Inc.

As of Dec 31, 2024, 430 patients enrolled in ARROS-1 trial of zidesamtinib for ROS1-positive NSCLC.
As of Dec 31, 2024, 596 patients enrolled in ALKOVE-1 trial of neladalkib for ALK-positive NSCLC.
Topline pivotal data for zidesamtinib expected H1 2025; NDA submission for TKI pre-treated ROS1+ NSCLC by mid-2025.
Topline pivotal data for neladalkib (NVL-655) expected by year-end 2025; Phase 3 ALKAZAR trial to initiate H1 2025.
Nuvalent presented at 43rd Annual J.P. Morgan Healthcare Conference on Jan 14, 2025.

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