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PDUFAApproval decision

Neladalkib (NVL-655) (ALK Inhibitor)

ALK-Altered Non-Small Cell Lung Cancer

GSKGSK
Expected catalystNovember 27, 2026Company guidance: Nov 27, 2026

Catalyst overview

Event details

Drug or asset
Neladalkib (NVL-655) (ALK Inhibitor)
Development stage
PDUFA
Event type
Approval decision
Indication
ALK-Altered Non-Small Cell Lung Cancer

Research summary

What is being tracked?

This catalyst tracks a PDUFA approval decision for Neladalkib (NVL-655) (ALK Inhibitor) in ALK-Altered Non-Small Cell Lung Cancer. The expected timing is based on the latest available company guidance and may change.

Development notes

07/22/26:- FDA decision for neladalkib in ALK-altered NSCLC due November 27, 2026.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

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Company

GSK

GSK · NYSE
Industry
Biotechnology
Pipeline assets
28
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Updated Aug 23, 2026. Dates can change; this is not investment advice.

Disclaimer: Biotech Stock Intel is an independent research platform. Information is provided for informational purposes only and is not investment or medical advice. Always verify catalyst dates against primary sources and conduct your own research.
Biotech Stock Intel© 2026 Biotech Stock Intel
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