Nuvalent, Inc. filed a New Drug Application (NDA) with the U.S. Food and Drug Administration on April 7 2026 for its investigational ALK‑selective inhibitor neladalkib, targeting patients who have progressed after treatment with two or more ALK tyrosine‑kinase inhibitors.
The filing is based on data from the global, registration‑directed ALKOVE‑1 Phase 1/2 trial, which enrolled heavily pre‑treated ALK‑positive non‑small cell lung cancer (NSCLC) patients. The trial reported an overall objective response rate of 31% in TKI‑pre‑treated patients and 46% in lorlatinib‑naïve patients, with intracranial objective response rates of 32% overall and 63% in lorlatinib‑naïve patients. The data also highlighted neladalkib’s brain‑penetrant profile and its activity against resistance mutations such as G1202R.
Neladalkib has received Breakthrough Therapy Designation and Orphan Drug Designation from the FDA, underscoring its potential to address a high‑value, treatment‑resistant patient segment that currently lacks effective options. The company’s cash position of approximately $1.4 billion as of December 31 2025 provides a runway to support ongoing development and potential commercialization.
Nuvalent’s OnTarget 2026 operating plan aims for its first potential FDA approval later in 2026. In addition to neladalkib, the company has an accepted NDA for zidesamtinib with a PDUFA target action date of September 18 2026, positioning it to broaden its pipeline portfolio.
Management emphasized the rapid pace of development, noting that the progression from first clinical trial initiation to NDA submission in less than four years reflects the company’s disciplined, patient‑centric approach. The filing marks a critical milestone that could accelerate access to a novel therapy for patients with limited treatment options.
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