Nuvalent reported Phase 1/2 data for neladalkib in ALK‑positive lung cancer showing tumor shrinkage in a meaningful subset of heavily pretreated patients and durable responses at 12–18 months in many responders. The company signaled readiness to engage the FDA on an approval pathway that could position neladalkib against existing ALK inhibitors. Companies presented overall response rate, duration‑of‑response and safety metrics at recent meetings and in corporate updates. Analysts and rival companies will monitor confirmatory datasets and regulatory interactions — if the agency accepts accelerated pathways, neladalkib could become a near‑term competitor to Pfizer’s Lorbrena.