Organization (Industry)
PUMA BIOTECHNOLOGY, INC.
ClinicalTrials.gov lists PUMA BIOTECHNOLOGY, INC. as lead sponsor of 38 trials. It has 20 active development programs and 14 approved assets.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 1 registered with a 2026 start date. The dashed outline is the pace from the 1 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 2.0 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers PUMA BIOTECHNOLOGY, INC.: 38 lead-sponsored trials and 2 legal-entity registrations.
Disease areas (17)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Breast Neoplasms | 28 |
| Lung Neoplasms | 5 |
| Neoplasm Metastasis | 5 |
| Carcinoma, Non-Small-Cell Lung | 2 |
| Colorectal Neoplasms | 2 |
Showing 5 of 17 disease areas.
Trials by start year as sponsor or collaborator (20)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2026 (partial year) | 1 |
| 2024 | 4 |
| 2023 | 1 |
| 2022 | 4 |
| 2021 | 1 |
| 2020 | 2 |
| 2019 | 4 |
| 2018 | 2 |
| 2017 | 3 |
| 2015 | 1 |
Showing 10 of 20 years.
Recruitment duration, a model prediction: 3 trials still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (20)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| NERATINIB | Breast Neoplasms | Phase 3 | 14 |
| Alisertib | Small Cell Lung Carcinoma | Phase 2 | 2 |
| Alisertib | Lung Neoplasms | Phase 2 | 2 |
| (nab)-paclitaxel | Lung Neoplasms | Phase 2 | 2 |
| Endocrine Therapy | Breast Neoplasms | Phase 2 | 1 |
Showing 5 of 20 active programs.
Approved assets (14)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| NERATINIB | 34 |
| "Capecitabine" | 5 |
| LAPATINIB | 2 |
| (nab)-paclitaxel | 5 |
| Temsirolimus | 3 |
Showing 5 of 14 approved assets.
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 3 of 4 hit target (n=4) | 40% on time (n=5) |
Journals published in (32)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Journal of clinical oncology : official journal of the American Society of Clinical Oncology | 9 |
| Annals of oncology : official journal of the European Society for Medical Oncology | 4 |
| Breast cancer research : BCR | 4 |
| Cancer chemotherapy and pharmacology | 2 |
| Cancer discovery | 2 |
Showing 5 of 32 journals.
SEC-reported annual financials (11)
Shown in this order: newest fiscal year first; SEC EDGAR XBRL companyfacts, USD as reported.
| Fiscal year | Revenue (USD) | Net income (USD) | R&D (USD) |
|---|---|---|---|
| 2025 | 228,371,000 | 31,111,000 | 62,068,000 |
| 2024 | 230,468,000 | 30,278,000 | 54,935,000 |
| 2023 | 235,637,000 | 21,591,000 | 50,382,000 |
| 2022 | 228,031,000 | 2,000 | 52,240,000 |
| 2021 | 253,155,000 | -29,126,000 | 71,870,000 |
| 2020 | 225,110,000 | -59,995,000 | 97,650,000 |
| 2019 | 272,260,000 | -75,595,000 | 132,851,000 |
| 2018 | 250,991,000 | -113,575,000 | 164,854,000 |
| 2017 | 27,685,000 | -291,955,000 | 207,810,000 |
| 2016 | not reported | -276,011,000 | 222,798,000 |
Showing 10 of 11 fiscal years.
Financing and grant events (14)
Shown in this order: most recent first.
| Date | Round type | Amount (USD) | Source |
|---|---|---|---|
| 2022-12-13 | Royalty / licensing | not disclosed | Sec extracted |
| 2022-12-12 | Private placement | 2,500,000 | Sec extracted |
| 2022-11-07 | Other financing | not disclosed | Sec extracted |
| 2022-09-16 | Royalty / licensing | 7 | Sec extracted |
| 2022-08-02 | Other financing | not disclosed | Edgar offerings |
Showing 5 of 14 events.
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 3 |
Climate targets, as filed (1)
| Reporting year | Net-zero target |
|---|---|
| 2025 | not disclosed |
Workforce and board diversity, as filed (1)
| Reporting year | Workforce % women | Board % women |
|---|---|---|
| 2025 | 46.0% | not disclosed |
Organization relationships (5)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Virginia Commonwealth University | Co sponsors trial with | 2 |
| Bristol Myers Squibb Co | Co sponsors trial with | 1 |
| Accelerate Brain Cancer Cure | Co sponsors trial with | 1 |
| Quadriga Biosciences (United States) | Co sponsors trial with | 1 |
| David Reardon, MD | Co sponsors trial with | 1 |
Latest dated events (78)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-09-17 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2024-11-19 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2024-06-11 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2024-02-08 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2024-01-12 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
Showing 5 of 78 events.
Biomarker capability evidence (236)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| ALB | Trial collaborator | Named in trial inclusion criteria |
| ALK | Trial sponsor | Named in trial inclusion criteria |
| AR | Trial collaborator | Named in trial inclusion criteria |
| BRAF | Trial collaborator | Named in trial inclusion criteria |
| BRCA1 | Trial collaborator | Named in trial inclusion criteria |
Showing 5 of 236 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, us granted patents, fda warning letters, fda untitled letters, fda recalls, fda import refusals, manufacturing and distribution sites, clia clinical laboratory certificates, and biomarkers this organization publishes on.