Nuvalent Submits New Drug Application (NDA) to FDA for Neladalkib in ALK-Positive NSCLC

On April 7, 2026, Nuvalent, Inc. announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead candidate, neladalkib. The application seeks approval for the treatment of patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with tyrosine kinase inhibitors (TKIs). This submission represents a significant regulatory milestone for the company as it moves toward potential commercialization of neladalkib for this specific patient population. The filing did not specify a target PDUFA date or provide detailed clinical data within the brief announcement, focusing instead on the procedural step of the NDA submission. Nuvalent remains focused on addressing the unmet needs of patients with kinase-driven cancers through its pipeline of selective small molecule inhibitors.