Neladalkib (NVL-655)

Phase 3

GSK plc (GSK)

00%

What is LOA?

Phase 3

Development Phase

Upcoming Catalysts

Historical Events

Regulatory Approvals

Upcoming Catalysts

What are catalysts?

GSKPDUFA$100.5B

Phase 3

FDA PDUFA Date neladalkib (NVL-655)

Neladalkib (NVL-655)• TKI pre-treated advanced ALK-positive NSCLC

Nov 27Confirmed

Source

00%

Competitive Landscape

14 competitors in Non-small Cell Lung Cancer

REGNLibtayo

Phase 3

MRKArm A: Pemetrexed Cisplatin

Phase 2

SNYoxaliplatine / gemcitabine / Vinorelbine

Drug Information

Target Indication

Non-small Cell Lung Cancer

Clinical Trial

NCT06765109

Last updated: 10/16/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Source: FDA Orange Book

Drug Science

Mechanism of action & safety profile

Developer

GSK

GSK plc

Pharmaceutical Preparations•Europe•NYSE

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Infections, Meningococcal

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FluoridePhase 3

Dental Caries

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View full pipeline

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