Puma Biotechnology

Puma Biotechnology

PBYI
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PBYI · Stock Price

USD 7.26+4.35 (+149.48%)
Market Cap: $380.4M

Historical price data

Market Cap: $380.4MPipeline: 56 drugs (2 Phase 3)Founded: 2007Employees: 100-250HQ: Los Angeles, United States

Overview

Puma Biotechnology is a U.S.-based, commercial-stage oncology company with a proven strategy of in-licensing and developing targeted cancer therapies. Its flagship product, NERLYNX, generates revenue for the extended adjuvant treatment of HER2-positive early breast cancer. The company is advancing alisertib, an Aurora A kinase inhibitor, in pivotal trials for small cell lung cancer and metastatic breast cancer, aiming to diversify its revenue base. Puma's inclusion in the NASDAQ Biotechnology Index underscores its transition to a sustainable commercial entity.

OncologyBreast CancerLung Cancer

Technology Platform

Puma does not have a proprietary discovery platform; its core operational platform is a targeted in-licensing and development model focused on acquiring global rights to clinical-stage oncology assets with validated mechanisms of action and derisking them through late-stage development and commercialization.

Pipeline

56
56 drugs in pipeline2 in Phase 3
DrugIndicationStageWatch
neratinib + capecitabine + lapatinibHER2+ Metastatic Breast Cancer (MBC)Phase 3
neratinibBreast CancerPhase 3
neratinibBreast NeoplasmsPhase 2
Paclitaxel + Trastuzumab + Neratinib + Doxorubicin + Cycloph...Breast CancerPhase 2
NeratinibAnatomic Stage I Breast CancerPhase 2

Funding History

4
Total raised:$320M
PIPE$125M
IPO$105M
Series B$60M
Series A$30M

Opportunities

Alisertib's Phase 3 trials in SCLC and metastatic breast cancer target large populations with high unmet need and limited late-line options.
Success in either indication would diversify Puma's revenue, reduce reliance on NERLYNX, and validate its in-licensing model for a second major asset.
The company's profitability provides a strategic advantage in funding these trials and pursuing potential partnerships.

Risk Factors

The company faces significant clinical risk with its pivotal alisertib trials; failure in both would impair growth.
NERLYNX revenues are under sustained competitive pressure from newer, more potent HER2 therapies like antibody-drug conjugates.
Puma also carries concentration risk, remaining heavily dependent on NERLYNX for nearly all its current revenue.

Competitive Landscape

NERLYNX competes in a dynamic HER2+ breast cancer market increasingly dominated by potent antibody-drug conjugates like Enhertu. Alisertib, if approved, would enter the crowded post-CDK4/6 inhibitor space in breast cancer and the niche late-line SCLC market, where its primary differentiation would be oral administration versus intravenous competitors like lurbinectedin.

Company Timeline

2007Founded

Founded in Los Angeles, United States

2011Series B

Series B: $60.0M

2013IPO

IPO — $105.0M

2014PIPE

PIPE: $125.0M