Nuvalent (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, announced on April 7, 2026, the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for neladalkib.
Neladalkib is an investigational, orally available, ALK-selective tyrosine kinase inhibitor (TKI) designed to treat patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who have previously received at least one TKI.
The therapy is specifically engineered to overcome the common resistance mutations that frequently emerge during earlier lines of treatment, while also penetrating the blood-brain barrier to address central nervous system (CNS) metastases.
The submission is supported by data from the global, registration-directed ALKOVE-1 Phase 1/2 clinical trial.
According to the company, the trial demonstrated robust objective response rates, durable intracranial activity, and a safety profile that was generally well-tolerated among the heavily pre-treated patient population.
Neladalkib has previously been granted both Breakthrough Therapy and Orphan Drug designations by the FDA, which may qualify the application for priority review.
If granted, a regulatory decision could be expected by the fourth quarter of 2026.