Puma Biotechnology
Puma Biotechnology is a US biopharmaceutical company (NASDAQ: PBYI) that develops and commercializes oncology therapies, primarily NERLYNX (neratinib), an FDA-approved oral tyrosine kinase inhibitor for HER2-positive breast cancer, with a Phase II pipeline candidate (alisertib) in breast and lung cancers.
- Company typePublic
- Founded2017
- HeadquartersLos Angeles, United States
- Headcount251–500
- GTM typeB2B
- OfferingHardware or Manufacturing
What Puma Biotechnology does
Puma Biotechnology, Inc. is a US-based, publicly traded biopharmaceutical company (NASDAQ: PBYI) headquartered in Los Angeles, California, focused on the development and commercialization of oncology therapies. The company's commercial portfolio centers on NERLYNX (neratinib), an oral small molecule tyrosine kinase inhibitor that received FDA approval in 2017 as extended adjuvant therapy for HER2-positive early-stage breast cancer. NERLYNX generated $204.1M of the company's $228.4M in FY2025 revenue, making it the sole marketed product and primary growth driver. Puma also advances a pipeline candidate, alisertib (an Aurora A kinase inhibitor), in Phase II clinical trials for breast cancer (ALISCA-Breast1, 164 patients enrolled) and small-cell lung cancer (ALISCA-Lung1, with Q2 2026 interim data expected at 60mg BID dosing). The company has achieved three consecutive years of profitability (2023-2025), reporting FY2025 net income of $31.1M.
Puma commercializes NERLYNX through a US specialty pharmaceutical field sales organization targeting oncologists and cancer treatment centers, with international expansion initiated via a Thailand launch in January 2026 following Thai FDA approval in December 2024. Revenue derives from two streams: NERLYNX product sales and royalty income from licensed intellectual property ($15.6M in Q4 2025). Management has guided 2026 NERLYNX product revenue to $194-198M and royalty revenue to $20-23M. The company is led by founder Alan H. Auerbach as Chairman, CEO and President, and operates as an independent entity with no parent company, having secured debt financing from Athyrium Capital Management ($125M note purchase agreement, 2021) and a small private placement ($10M, March 2022) as its primary capital events. In December 2025 Puma was added to the Nasdaq Biotechnology Index, reflecting its commercialization and profitability milestones.
The company's competitive positioning rests on regulatory exclusivity for NERLYNX in the HER2-positive extended adjuvant setting, an established specialty oncology distribution network, and proprietary pipeline assets. Principal strategic risks include single-product revenue concentration, the absence of meaningful diversification beyond HER2+ breast cancer, and the early-stage nature of the alisertib pipeline. Growth levers include international geographic expansion, indication broadening for neratinib and alisertib, and potential pipeline partnering or licensing transactions.
Puma Biotechnology firmographics
Firmographics- Name
- Puma Biotechnology
- Legal name
- Puma Biotechnology, Inc.
- Website
- https://pumabiotechnology.com
- Company type
- Public
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 251–500 employees
- Short description
- Puma Biotechnology is a US biopharmaceutical company (NASDAQ: PBYI) that develops and commercializes oncology therapies, primarily NERLYNX (neratinib), an FDA-approved oral tyrosine kinase inhibitor for HER2-positive breast cancer, with a Phase II pipeline candidate (alisertib) in breast and lung cancers.
- Ownership category
- akta.pro rank
Puma Biotechnology industry classification
Industry- Product category
- Oncology Pharmaceuticals
- NAICS
- Pharmaceutical and Medicine Manufacturing (3254)
- SIC
- Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Medical Oncology (HLAKAFAB)
- akta.pro secondary industry
- Breast Oncology (HLAKAFAJ)
Keywords
Where Puma Biotechnology is headquartered
LocationHeadquarters
- HQ city
- Los Angeles
- HQ country
- United States
- HQ region
- North America
Markets served
Puma Biotechnology business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Marketing or Sales, Personnel, Operations, Others
Revenue model
- NERLYNX Product Revenue: Sales of FDA-approved drug NERLYNX (neratinib) for HER2-positive breast cancer. Revenue from $2.79 private placement in 2022 and $100M Athyrium financing in 2021 has supported commercialization.
- Royalty Revenue: Royalty income from licensed intellectual property and international partnerships. Q4 2025 royalties were $15.6 million. Full year 2025 royalty revenue was $20-23 million.
Go-to-market motion2 records
Distribution channels2 records
Marketing channels3 records
Puma Biotechnology product offering
Product offeringCore offering
Puma Biotechnology develops and commercializes oncology therapeutics, with its primary product being NERLYNX (neratinib), an FDA-approved oral small-molecule tyrosine kinase inhibitor for the extended adjuvant treatment of HER2-positive early-stage breast cancer. The company also develops alisertib, an Aurora A kinase inhibitor currently in Phase II clinical trials for HER2-positive breast cancer and small-cell lung cancer.
Product overview
Puma Biotechnology is a biopharmaceutical company focused on developing and commercializing cancer care products. The company's commercial portfolio centers on NERLYNX (neratinib), an FDA-approved HER2-positive breast cancer therapy that represents the company's sole marketed product and primary revenue driver. The pipeline includes alisertib, an experimental drug in Phase II studies for breast cancer and small-cell lung cancer. The company has maintained profitability for three consecutive years, reporting full-year 2025 net income of $31.1 million on revenue of $228.4 million.
Differentiator
Problem solved
Functional benefit
Brands
- NERLYNX: FDA-approved drug for HER2-positive breast cancer treatment
- Alisertib
Products and services
- NERLYNX (neratinib)
- Alisertib
Companies that use Puma Biotechnology
Customer profileSegments2 records
Ideal customer profiles2 records
Puma Biotechnology technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature2 records
Puma Biotechnology partnerships and signals
Strategic signalScale indicators10 records
Recent moves3 records
Expansion highlights5 records
Puma Biotechnology competitors and assessment
Company assessmentMarket position
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Puma Biotechnology financial estimates
Financial estimateRevenue estimate
Valuation estimate
Puma Biotechnology leadership team
Management profileNumber of profiles
Profiles4 records
Puma Biotechnology funding detail
Funding detailFunding overview
Funding rounds7 records
Investors12 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Puma Biotechnology M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Puma Biotechnology
What does Puma Biotechnology do?
Puma Biotechnology develops and commercializes oncology therapeutics, with its primary product being NERLYNX (neratinib), an FDA-approved oral small-molecule tyrosine kinase inhibitor for the extended adjuvant treatment of HER2-positive early-stage breast cancer. The company also develops alisertib, an Aurora A kinase inhibitor currently in Phase II clinical trials for HER2-positive breast cancer and small-cell lung cancer.
Is Puma Biotechnology a public or private company?
Puma Biotechnology is a public company. It is classified as public and is currently operating.
When was Puma Biotechnology founded?
Puma Biotechnology was founded in 2017. It employs 251 to 500 people.
Where is Puma Biotechnology based?
Puma Biotechnology is headquartered in Los Angeles, United States, in the North America region.
How does Puma Biotechnology make money?
Two revenue lines are on record. NERLYNX Product Revenue is the primary driver. The others are royalty Revenue.
Does Puma Biotechnology have an API?
No public API is recorded for Puma Biotechnology.
What industry is Puma Biotechnology in?
Puma Biotechnology's product category is Oncology Pharmaceuticals. Its primary akta.pro industry code is HLAKAFAB, Medical Oncology, with a secondary code of HLAKAFAJ, Breast Oncology. Its NAICS code is 3254 and its SIC code is 2834.