Nuvalent Announces Positive Pivotal Data for Zidesamtinib in Lung Cancer

Nuvalent Inc. (NASDAQ:NUVL) is one of the best high short interest stocks with huge upside potential. On June 24, Nuvalent announced positive 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.

Nuvalent Announces Positive Pivotal Data for Zidesamtinib in Lung Cancer

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 company that develops therapies for patients with cancer.

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Disclosure: None. This article is originally published at Insider Monkey.