Nuvalent Inc. (NASDAQ: NUVL) announced that the U.S. Food and Drug Administration has accepted its New Drug Application for neladalkib and granted it Priority Review with a target action date of November 27, 2026.

The application covers neladalkib for treatment of patients with tyrosine kinase inhibitor pre-treated advanced ALK-positive non-small cell lung cancer. The submission is based on data from the ALKOVE-1 Phase 1/2 clinical trial.

The company also announced that Georg Pirmin Meyer, M.D., has joined as Chief International Officer to lead global expansion efforts outside the United States.

Nuvalent now has New Drug Applications under FDA review for both neladalkib and zidesamtinib, another investigational cancer drug for ROS1-positive NSCLC. The zidesamtinib application has a target action date of September 18, 2026.

"Our U.S. commercial and medical affairs teams are in place and focused on establishing the strong foundational systems and infrastructure required to effectively deliver on multiple synergistic launches in biomarker-driven NSCLC," said James Porter, Chief Executive Officer of Nuvalent.

Meyer previously served as Senior Vice President and General Manager, International at Blueprint Medicines, where he led European market preparation and launches of Ayvakit across three indications. He also held roles at Vertex Pharmaceuticals, Amgen and Sanofi.

Neladalkib has received breakthrough therapy designation from the FDA for patients with locally advanced or metastatic ALK-positive NSCLC who have been previously treated with two or more ALK tyrosine kinase inhibitors.

Data from the ALKOVE-1 trial for both TKI pre-treated and TKI-naïve patients will be presented at the American Society of Clinical Oncology Annual Meeting from May 29 to June 2, 2026, in Chicago.