Neratinib

Generic Name
Neratinib
Brand Names
Nerlynx
Drug Type
Small Molecule
Chemical Formula
C30H29ClN6O3
CAS Number
698387-09-6
Unique Ingredient Identifier
JJH94R3PWB
Background

Neratinib was approved in July 2017 for use as an extended adjuvant therapy in Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer. Approval was granted to Puma Biotechnology Inc. for the tradename Nerlynx. Neratinib is currently under investigation for use in many other forms of cancer.

Indication

For use as an extended adjuvant treatment in adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy [FDA Label].

Associated Conditions
Breast Cancer
Associated Therapies
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defenseworld.net
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XTX Topco Ltd Sells 22227 Shares of Puma Biotechnology, Inc.

XTX Topco Ltd reduced its stake in Puma Biotechnology by 45.7% in Q3. Several institutional investors adjusted their holdings in Puma Biotechnology in Q2. Puma Biotechnology's stock opened at $2.75 on Friday, with a market cap of $134.99M. The company reported $0.41 EPS for Q3, surpassing estimates. StockNews.com downgraded Puma Biotechnology from 'strong-buy' to 'buy'. Puma Biotechnology focuses on cancer care products, including NERLYNX.
stocknews.com
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3 Emerging Biotech Stocks Developing Breakthrough Therapies

The biotech industry is growing rapidly due to advancements in genomic research, personalized medicine, and innovative platforms, with key stocks like HRMY, TRDA, and PBYI leading the charge. The global biotechnology market is projected to reach $4.61 trillion by 2034, driven by increased investment, favorable regulations, and high demand for novel therapies. TRDA specializes in EEV therapeutics for neuromuscular diseases, HRMY focuses on rare and neurological diseases, and PBYI develops cancer treatments, all showing strong financials and growth potential.
biospace.com
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Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)

Puma Biotechnology granted a 7,500-share restricted stock unit award to a new non-executive employee on Dec 2, 2024, under its 2017 Employment Inducement Incentive Award Plan. The award vests over three years, with vesting conditions tied to continued employment.
stocktitan.net
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Puma Biotechnology Reports Inducement Awards

Puma Biotechnology (NASDAQ: PBYI) approved a 7,500-share restricted stock unit award for a new non-executive employee under its 2017 Employment Inducement Incentive Award Plan. The award vests over three years, with one-third vesting on December 1, 2025, and one-sixth every six months thereafter, contingent on continued employment, complying with Nasdaq Listing Rule 5635(c)(4).
gurufocus.com
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Puma Biotechnology Announces Initiation of ALISCA™-Breast1 Phase

Puma Biotechnology initiates ALISCA™-Breast1 Phase II trial of alisertib combined with endocrine therapy for HR+, HER2-negative recurrent or metastatic breast cancer patients previously treated with CDK 4/6 inhibitors. The trial aims to determine the optimal alisertib dose and evaluate efficacy endpoints within biomarker subgroups, with initial data expected in 2025.
investing.com
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Earnings call: Puma Biotechnology reports robust Q3 growth

Puma Biotechnology reported Q3 2024 revenue of $80.5 million, up from $51.6 million in Q3 2023, driven by NERLYNX sales and royalty revenue from China. The company discussed ongoing clinical trials, including Phase 2 studies of alisertib, and provided financial forecasts for Q4 and fiscal year 2024.
stocktitan.net
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Puma Biotechnology Reports Third Quarter 2024 Financial Results

Puma Biotechnology reported Q3 2024 revenue of $80.5M, including $56.1M from NERLYNX® and $24.4M in royalties, with net income of $20.3M ($0.41 per share). The company updated its 2024 guidance to $187-190M in net product revenue and $15-17M in net income.
tipranks.com
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Puma Biotechnology Reports Strong Q3 2024 Growth

Puma Biotechnology's Q3 2024 earnings show a significant increase in net income and total revenue, driven by robust NERLYNX sales and higher royalty revenue. Key metrics include a 9% rise in product revenue to $56.1 million, net income of $20.3 million ($0.41 per share), and total revenue of $80.5 million. The company holds $97 million in cash and is advancing its alisertib development for cancer treatment.
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