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.
Clinical Trials
94
52 active
Approvals
4
Total approvals
Agencies
2
Regulatory bodies
Founded
2010
Active, not recruiting
52
55.3%
Completed
33
35.1%
Recruiting
6
6.4%
Terminated
2
2.1%
Withdrawn
1
1.1%
- Puma Biotechnology has initiated the Phase II ALISCA-Lung2 trial (PUMA-ALI-4202; NCT07465757) testing alisertib plus paclitaxel in advanced small cell lung cancer. - The sequential dose escalation study will enroll approximately 50 patients whose disease progressed on or after platinum-based chemotherapy and immunotherapy. - The primary endpoint is safety and tolerability of alisertib with paclitaxel, with objective response rate, duration of response and survival as secondary endpoints. - Investigators will also assess clinical biomarkers to identify patient subsets most likely to benefit from the aurora kinase A inhibitor.
- Puma Biotechnology has initiated two Phase II clinical trials for alisertib, a selective aurora kinase A inhibitor, targeting small cell lung cancer and breast cancer patients. - The ALISCA-Lung1 trial launched in February 2024 evaluates alisertib monotherapy for extensive-stage small cell lung cancer treatment. - The ALISCA-Breast1 trial began in November 2024, testing alisertib combined with endocrine therapy for HER2-negative, HR-positive metastatic breast cancer. - Alisertib represents Puma's expansion beyond its established NERLYNX franchise into new oncology indications with significant unmet medical needs.
- Puma Biotechnology raised its full-year 2026 total revenue guidance to $222–$229 million, up from prior estimates of $214–$221 million, reflecting confidence in Nerlynx growth. - Nerlynx (neratinib) generated $42 million in Q1 2026 sales, surpassing management's guidance range of $36–$39 million despite a 2.6% year-over-year decline. - The company's alisertib pipeline candidate is advancing in two Phase II studies for hormone receptor-positive breast cancer and small-cell lung cancer, with interim data expected in late 2026 or early 2027. - Puma Biotechnology's stock has rallied 19.4% over the past three months, outperforming the industry's 6.9% decline, driven by the raised outlook and pipeline momentum.
- NERLYNX (neratinib) received Thai FDA approval in December 2024 for treating early-stage and advanced HER2+ breast cancer patients. - Clinical trials demonstrate the oral therapy reduces recurrence risk by up to 42% in hormone receptor-positive patients when started within 12 months of trastuzumab completion. - The drug addresses a significant unmet need in Thailand, where breast cancer affects over 20,000 women annually and HER2+ tumors carry increased risk of metastasis and recurrence. - Specialised Therapeutics launched the therapy under exclusive license from Puma Biotechnology, marking their first product introduction in Thailand.
- Puma Biotechnology was added to the NASDAQ Biotechnology Index effective December 19, 2025, recognizing the company's commercial execution, profitability, and clinical advancement. - The inclusion reflects sustained demand for NERLYNX, an FDA-approved HER2-targeted therapy for breast cancer, and progress with alisertib, an aurora kinase A inhibitor in Phase II trials. - The company is advancing two Phase II clinical trials with alisertib: ALISCA-Lung1 for extensive-stage small cell lung cancer and ALISCA-Breast1 for HER2-negative, hormone receptor-positive metastatic breast cancer.
- A new comprehensive report analyzes the global clinical trial landscape for HER2+ breast cancer, providing crucial data on trial numbers, enrollment patterns, and regional distribution across G7 and E7 countries. - The analysis covers clinical trials conducted worldwide with data segmented by region, phase, trial status, endpoints, and sponsor type, drawing from over 80 clinical trial registries. - Major pharmaceutical companies including Roche, Pfizer, GSK, Novartis, and AstraZeneca are featured among the key industry players conducting HER2+ breast cancer trials. - The report includes enrollment trends over the past five years and provides comparative analysis of trial success rates to help stakeholders understand market dynamics and devise competitive strategies.
- TOLREMO therapeutics has appointed Alessandra Cesano, MD, PhD, to its Board of Directors and named Florian D. Vogl, MD, PhD, as Chief Medical Officer to strengthen leadership capabilities. - The leadership changes follow promising clinical data presentation at ASCO 2025, where TT125-802 demonstrated significant clinical activity as the first CBP/p300 inhibitor to show efficacy in solid tumors. - TT125-802 showed rapid, deep and durable objective responses in KRAS-G12C and EGFR-mutant non-small cell lung cancer with a best-in-class safety profile without thrombocytopenia. - The company plans to initiate clinical trials evaluating TT125-802 in combination with targeted therapies for advanced tumor indications including EGFR- and KRAS-mutated lung cancer and multiple myeloma.
- 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 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 has acquired rights to alisertib from Takeda for $7 million upfront, with potential milestone payments of $287 million plus royalties. - The aurora kinase A inhibitor will be developed for multiple cancer indications, including hormone receptor-positive breast cancer, triple-negative breast cancer, and small cell lung cancer. - Despite previous setbacks in lymphoma trials, alisertib has shown promising anti-tumor activity both as monotherapy and in combination with other anticancer drugs.
