FDA accepts Nuvalent's neladalkib NDA with priority review, action date Nov 27, 2026, plus new Chief International Officer appointed.

Nuvalent's New Drug Application for neladalkib, a targeted therapy for advanced ALK-positive non-small cell lung cancer previously treated with TKIs, has been accepted by the FDA with priority review and a PDUFA action date of November 27, 2026. The drug aims to overcome resistance seen in current ALK inhibitors and penetrate the brain to treat metastases. Nuvalent also appointed Georg Pirmin Meyer, M.D., as Chief International Officer to lead global expansion efforts. This marks a key step for Nuvalent as it prepares for potential U.S. approval and international market entry for neladalkib and other pipeline candidates.