Nuvalent released Phase 1/2 data for neladalkib in ALK‑positive lung cancer showing objective responses in patients who progressed on prior ALK inhibitors, with a reported overall response rate around the low‑30s and durable responses at 12–18 months. The company said it will pursue regulatory discussions with the FDA toward a filing. Data encompassed 253 patients treated after failure of earlier ALK inhibitors; responses persisted in a majority at one year and remained substantial at 18 months for many responders. The company and analysts signaled potential for an accelerated review given the unmet need after resistance to earlier ALK drugs. If regulators accept Nuvalent’s dossier, neladalkib could challenge incumbents like Pfizer’s Lorbrena and reshape sequencing choices for ALK‑driven NSCLC. The readout also underscores investor appetite for targeted kinase programs that can recapture efficacy after resistance emerges.