Guardant Health, Inc. announced a multi-year strategic collaboration with Nuvalent, Inc., a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, to support the development and potential commercialization of Nuvalent?s oncology pipeline using the tissue and liquid offerings of the Guardant Infinity platform. The collaboration reflects the growing importance of precision diagnostics in oncology drug development, where biomarker-driven approaches are increasingly essential for identifying appropriate patient populations, improving trial efficiency, and supporting regulatory approvals. As key components of the collaboration, Guardant Health and Nuvalent plan to utilize Guardant?s portfolio of tissue and liquid biopsy tests to support certain Nuvalent global clinical studies; evaluate opportunities to develop Guardant tissue and/or liquid biopsy assays as companion diagnostics (CDx) to support potential regulatory approvals of Nuvalent?s current investigational candidates; and collaborate on the global commercialization of Nuvalent?s product candidates, if approved, and Guardant companion diagnostics across major global key markets.
Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer. It develops small molecules that have the potential to overcome resistance, minimize adverse events, and address brain metastases. It is advancing a robust pipeline with investigational candidates for ROS proto-oncogene 1 (ROS1)-positive, anaplastic lymphoma kinase (ALK)-positive, and human epidermal growth factor receptor 2 (HER2)-positive non-small cell lung cancer, and multiple discovery-stage research programs. Its product candidate, Zidesamtinib (NVL-520), is being developed for patients with ROS1-positive non-small cell lung cancer (NSCLC). NVL-520 is a novel ROS1-selective inhibitor. Its product candidate, Neladalkib (NVL-655), is being developed for patients with ALK-positive NSCLC. NVL-655 is a brain-penetrant ALK-selective inhibitor. Its product candidate, NVL-330, is a brain-penetrant HER2-selective inhibitor.
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