Neratinib

Phase 3

PUMA BIOTECHNOLOGY, INC. (PBYI)

Phase 3

Development Phase

Upcoming Catalysts

Historical Events

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

2 competitors in Advanced Breast Cancer

AZNEtcamah

Approved

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Drug Information

Target Indication

Advanced Breast Cancer

Clinical Trial

NCT00777101

Last updated: 12/29/2025

Patent & Exclusivity

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

Source: FDA Orange Book

Regulatory Approvals

EMA8/31/2018

Nerlynx

Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.

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Drug Science

Mechanism of action & safety profile

Developer

PBYI

PUMA BIOTECHNOLOGY, INC.

Pharmaceutical Preparations•North America•NASDAQ

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