New Drug Application for neladalkib in TKI pre-treated advanced ALK-positive NSCLC accepted for filing with Priority Review by the FDA with PDUFA target action date of November 27, 2026Veteran biopharmaceutical

New Drug Application for neladalkib in TKI pre-treated advanced ALK-positive NSCLC accepted for filing with Priority Review by the FDA with PDUFA target action date of November 27, 2026

Veteran biopharmaceutical executive, Georg Pirmin Meyer, M.D., joins as Chief International Officer to lead Nuvalent's global expansion strategy

CAMBRIDGE, Mass., May 27, 2026 /PRNewswire/ -- Nuvalent, Inc. (NASDAQ:NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the acceptance of its New Drug Application (NDA) for neladalkib for filing by the U.S. Food and Drug Administration (FDA). The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026. The company further announced that Georg Pirmin Meyer, M.D., has joined the company as Chief International Officer.