Neladalkib (NVL-655) - (ALKove-1)

May 27, 2026: Nuvalent, Inc. (NASDAQ: NUVL) announced the FDA accepted for filing its New Drug Application (NDA) for neladalkib, an investigational ALK-selective inhibitor, for tyrosine kinase inhibitor (TKI) pre-treated advanced ALK-positive non-small cell lung cancer (NSCLC). The NDA received Priority Review with a PDUFA target action date of November 27, 2026. The submission is based on data from TKI pre-treated ALK-positive NSCLC patients in the global, registration-directed ALKOVE-1 Phase 1/2 trial (NCT05384626). Nuvalent said these data, along with preliminary data in TKI-naïve patients, will be presented in an oral presentation at the 2026 ASCO Annual Meeting (May 29–June 2, 2026, Chicago). Neladalkib has FDA Breakthrough Therapy Designation (post–≥2 ALK TKIs) and Orphan Drug Designation (ALK-positive NSCLC).

Zidesamtinib: Nuvalent also noted the FDA has accepted its NDA for zidesamtinib for adult locally advanced/metastatic ROS1-positive NSCLC after ≥1 prior ROS1 TKI, with a PDUFA date of September 18, 2026 (based on ARROS-1 Phase 1/2 results); the program also has Breakthrough Therapy and Orphan Drug designations.

Business: Georg Pirmin Meyer, M.D., was appointed Chief International Officer to lead international expansion.