Nuvalent reported Phase 1/2 data for neladalkib showing tumor shrinkage in a significant subset of ALK‑positive lung cancer patients whose disease progressed after prior ALK inhibitors. The company said responses persisted in many patients for at least 12–18 months across the 253‑patient cohort, positioning neladalkib for regulatory discussions with the FDA about a potential accelerated filing. Company statements and STAT reporting framed the results as a possible challenge to Pfizer’s Lorbrena, citing durable responses and a favorable side‑effect profile reported to date. The data elevate the competitive landscape for ALK‑targeted therapies and could drive rapid uptake if regulatory pathways proceed.