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Puma Biotechnology

Puma Biotechnology logo
🇺🇸United States
Ownership
Public
Established
2010-01-01
Employees
185
Market Cap
$124.5M
Website
http://www.pumabiotechnology.com
Introduction

Puma Biotechnology, Inc. is a biopharmaceutical company. It acquires and develops innovative products for the treatment of various forms of cancer. It focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seek to further develop those drug candidates for commercial use. The company was founded by Alan H. Auerbach on September 15, 2010 and is headquartered in Los Angeles, CA.

Er-Kim and Puma Biotechnology Partner to Bring NERLYNX to Eastern Europe and Central Asia for HER2-Positive Breast Cancer Patients

• Er-Kim has signed an exclusive distribution agreement with Puma Biotechnology to commercialize NERLYNX (neratinib) in ten countries across Eastern Europe and Central Asia, expanding access to this targeted HER2 therapy. • NERLYNX is approved for early-stage HER2-positive breast cancer patients previously treated with trastuzumab-based therapy, as well as for metastatic HER2-positive breast cancer in combination with capecitabine. • The partnership addresses significant regional disparities in breast cancer treatment availability, with breast cancer being the most common cancer among women globally, affecting 2.3 million new patients in 2022.

Puma Biotechnology Advances Clinical Development of Alisertib in Lung and Breast Cancer

• Puma Biotechnology has launched two Phase II clinical trials for alisertib, targeting extensive-stage small cell lung cancer as monotherapy and HER2-negative HR-positive metastatic breast cancer in combination with endocrine therapy. • The company's expansion into alisertib development follows their success with NERLYNX (neratinib), which is FDA-approved for HER2-positive breast cancer in both early-stage and metastatic settings. • Alisertib, an oral aurora kinase A inhibitor, represents Puma's strategic expansion in oncology, with the company securing exclusive development and commercialization rights in September 2022.

Puma Biotechnology Reports Strong Financial Performance for Q4 and Full Year 2024

• Puma Biotechnology reported Q4 2024 net income of $19.3 million ($0.39 per share), a significant increase from $12.3 million in Q4 2023, driven by strong NERLYNX sales and a $7.1 million tax benefit. • The company achieved full-year 2024 net income of $30.3 million ($0.62 per share), marking its third consecutive year of profitability while maintaining a strong cash position of approximately $101 million. • Puma advanced its clinical pipeline with the initiation of ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine therapy for HER2-negative, HR-positive metastatic breast cancer.

Novel HER2-Targeted Therapies Show Promise in Advanced Breast Cancer

• Trastuzumab duocarmazine significantly improves progression-free survival compared to physician's choice in pretreated HER2-positive metastatic breast cancer patients. • Combining eribulin with trastuzumab and pertuzumab demonstrates non-inferior progression-free survival versus taxanes in first-line HER2-positive advanced breast cancer. • Pertuzumab retreatment with trastuzumab and chemotherapy shows a significant overall survival benefit in HER2-positive locally advanced/metastatic breast cancer.

Puma Biotechnology Launches Phase II Trial of Alisertib for HR-Positive Metastatic Breast Cancer

• Puma Biotechnology has initiated ALISCA™-Breast1, a Phase II clinical trial evaluating alisertib in combination with endocrine therapy for HER2-negative, HR-positive metastatic breast cancer patients. • The company is expanding its alisertib development program, which began with ALISCA™-Lung1 in February 2024 for extensive-stage small cell lung cancer as monotherapy. • Alisertib, an oral aurora kinase A inhibitor acquired by Puma in 2022, represents the company's strategic expansion beyond its FDA-approved NERLYNX® (neratinib) franchise for HER2-positive breast cancer.
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