Nuvalent disclosed Phase 1/2 data for neladalkib in ALK‑positive lung cancer patients who progressed on prior ALK inhibitors, reporting a 31% overall response rate with many responses durable at 12 and 18 months. The data support an expedited regulatory path and position neladalkib as a potential challenger to established ALK inhibitors, including Pfizer’s Lorbrena. Company management said the results enable near‑term FDA discussions on filing strategy. Competitors and payers will scrutinize comparative efficacy, resistance profiles and tolerability as neladalkib advances toward potential approval.