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Nuvalent Announces Positive Pivotal Data for Zidesamtinib in Lung Cancer [Yahoo! Finance]

Nuvalent, Inc. - Class A (NUVL) 
NASDAQ:AMEX Investor Relations: nuvelinc.com/company/investor_relations.html
Company Research Source: Yahoo! Finance
pivotal data from its global ARROS-1 Phase 1/2 clinical trial for zidesamtinib. The novel ROS1-selective inhibitor is being developed for TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer/NSCLC. The company also provided updates on the front-line development strategies for its parallel lead programs in both ROS1-positive and ALK-positive NSCLC. For zidesamtinib, Nuvalent has aligned with the FDA on its NDA submission strategy for TKI pre-treated patients with advanced ROS1-positive NSCLC. A physician standing in a lab, with vials of biopharmaceuticals in hand. The FDA has agreed to accept the NDA for participation in the Real-Time Oncology Review/RTOR pilot program, which allows for earlier submission of topline data to expedite the FDA's evaluation. Nuvalent plans to initiate a rolling NDA submission this July, with completion targeted for Q3 2025. Nuvalent Inc. (NASDAQ:NUVL) is a clinical-stage biopharmaceutical compa Show less Read more
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