Nuvalent submits NDA to FDA for neladalkib in ALK-positive lung cancer

Nuvalent, Inc.

NDA submitted to FDA on April 7, 2026, for neladalkib in TKI pre-treated advanced ALK-positive NSCLC.
Neladalkib is a novel ALK inhibitor targeting advanced ALK+ non-small cell lung cancer.
Submission marks regulatory milestone; no additional details on acceptance or review timeline provided.
Nuvalent (NUVL) expects FDA review of the NDA for potential market approval.

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