Puma Biotechnology Inc (Puma Biotechnology) is a biopharmaceutical company focused on developing and commercializing innovative cancer treatments. The company's primary product is NERLYNX (neratinib), an oral medication used for the treatment of certain HER2-positive breast cancers. NERLYNX is a potent irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors (EGFR), including HER1, HER2, and HER4. It is approved in the United States for two indications: the extended adjuvant treatment of adult patients with early-stage HER2 overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy, and in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

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Puma Biotechnology is actively engaged in research and development initiatives aimed at advancing cancer treatment through innovative therapies. The company's R&D efforts are primarily focused on the development of NERLYNX (neratinib) and alisertib, targeting various cancer types. NERLYNX is an oral version of neratinib, a potent irreversible tyrosine kinase inhibitor targeting HER2-positive breast cancers. It is approved for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy, and in combination with capecitabine for advanced or metastatic HER2-positive breast cancer. Puma Biotechnology continues to explore additional therapeutic applications for NERLYNX, leveraging its mechanism of action to potentially benefit patients with other HER2-positive cancers. The company has in-licensed alisertib, a selective, small-molecule inhibitor of Aurora Kinase A, from Takeda Pharmaceutical Company Ltd. Alisertib disrupts mitosis, leading to apoptosis of tumor cells dependent on Aurora Kinase A, and has shown potential in treating various cancer types, including hormone receptor-positive breast cancer, triple-negative breast cancer, and small cell lung cancer. The company has initiated several clinical trials to evaluate the efficacy of alisertib, including the ALISCA-Lung1 Phase II trial for extensive-stage small cell lung cancer and the ALISCA-Breast1 Phase II trial for hormone receptor-positive breast cancer. These trials are designed to assess the drug's effectiveness and safety, with a focus on biomarker-driven patient populations. In FY2025, the company incurred expenses of US$62.1 million on R&D, which as a percentage of revenue, stood at 27.2%.