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Nuvalent announced that the FDA has granted breakthrough therapy designation (BTD) for NVL-655, a novel ALK-selective tyrosine kinase inhibitor (TKI) designed to treat locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) in patients previously treated with two or more ALK TKIs. ALK rearrangements occur in up to 5% of metastatic NSCLCs, with 40% of these patients presenting brain metastases at diagnosis, and 50% developing resistance mutations after treatment. NVL-655 aims to address these challenges with brain-penetrant properties and minimal off-target CNS adverse events. The BTD is based on Phase 1 trial results, with Phase 2 enrollment ongoing. Nuvalent plans an update from the ALKOVE-1 trial in the second half of 2024.
Nuvalent, a clinical-stage biopharmaceutical company, highlighted pipeline progress, reiterated key milestones, and reported strong financial results for the first quarter of 2024. The company is focused on developing novel kinase inhibitors for cancer treatment, with anticipated milestones including updates from ongoing clinical trials and a potential first approval in 2026. Nuvalent's ROS1 and ALK programs are progressing well, with preclinical data demonstrating the effectiveness of their inhibitors. The company also plans to initiate a Phase 1 trial for its HER2 program in 2024. Financially, Nuvalent has a solid cash position expected to fund operations into 2027.
