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Nuvalent submits FDA application for neladalkib to treat advanced ALK-positive NSCLC after prior TKI therapy

Company Fundamentals
07 Apr 2026
PRNewsWire
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Bullish
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Nuvalent has submitted a New Drug Application (NDA) to the FDA for neladalkib, an investigational ALK-selective inhibitor aimed at treating advanced ALK-positive non-small cell lung cancer (NSCLC) in patients previously treated with tyrosine kinase inhibitors (TKIs). The application is based on positive data from the global ALKOVE-1 Phase 1/2 trial, showing neladalkib's effectiveness including brain metastases responses and a favorable safety profile. Neladalkib has received breakthrough therapy and orphan drug designations from the FDA, highlighting its potential to address resistance seen with current ALK inhibitors. Nuvalent plans to share detailed trial results at a future medical meeting and is committed to working with the FDA to bring this treatment to patients quickly.

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