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PUMA BIOTECHNOLOGY, INC. (PBYI)

Puma Biotechnology, Inc. is a biopharmaceutical company dedicated to the global development and commercialization of treatments aimed at advancing cancer care. Its lead drug candidate, orally administered neratinib (PB272), targets a range of indications. These include patients with early-stage HER2-overexpressed/amplified breast cancer, as well as adults suffering from advanced or metastatic HER2-positive breast cancer when used in combination with capecitabine. Furthermore, PB272 is being explored for solid tumors exhibiting HER2 mutations. The company holds a licensing agreement with Pfizer, Inc. for this drug and has established sub-licensing partnerships with Specialised Therapeutics Asia Pte Ltd., CANbridge BIOMED Limited, Pint Pharma International SA, Knight Therapeutics, Inc., Pierre Fabre Medicament SAS, and Bixink Therapeutics Co., Ltd. Established in 2010, Puma Biotechnology maintains its headquarters in Los Angeles, California.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Puma Biotechnology, Inc. logo

Puma Biotechnology, Inc.

NASDAQ:PBYIHealthcare
-0.95%$10.44
AH$10.72+2.67%vs close
Mkt Cap$538.91M
Float39.2M
O/S51.62M
Vol
$ Vol
RVOL
Inst Own75.2%
SI11.6%
Earnings
Dilution
Puma Biotechnology, Inc. logoNASDAQ:PBYI$10.44-0.95%
Phase Distribution
38 lead-sponsored trials·3 active·32 completed
Phase 118
Phase 1/25
Phase 211
Phase 32
Not applicable2
(21 more as collaborator)
Status Overview
Recruiting3
Completed32
Stopped3

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 3
    Completed

    Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

    neratinib

    Breast Cancer

    Enrollment
    2,840
    Start
    Jul 2009
    Primary Completion
    Aug 2014
    Completion
    Oct 2019
    NCT00878709
  • Phase 3
    Completed

    A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting

    neratinib, capecitabine

    HER2+ Metastatic Breast Cancer (MBC)

    Enrollment
    621
    Start
    Mar 2013
    Primary Completion
    Sep 2018
    Completion
    Dec 2019
    NCT01808573
  • Phase 2
    Completed

    Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer

    HKI-272

    Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

    Enrollment
    172
    Start
    Dec 2005
    Primary Completion
    Jan 2009
    Completion
    Jan 2009
    NCT00266877
  • Phase 2
    Completed

    Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer

    neratinib

    Breast Neoplasms, Neoplasms

    Enrollment
    136
    Start
    Aug 2006
    Primary Completion
    Apr 2008
    Completion
    Jan 2018
    NCT00300781
  • Phase 2
    Completed

    Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

    Neratinib, Lapatinib

    Advanced Breast Cancer, Breast Cancer

    Enrollment
    233
    Start
    Feb 2009
    Primary Completion
    Mar 2011
    Completion
    Jun 2018
    NCT00777101
  • Phase 2
    Completed

    Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer

    Neratinib, Trastuzumab

    Breast Cancer

    Enrollment
    479
    Start
    Aug 2009
    Primary Completion
    Aug 2013
    Completion
    Jun 2018
    NCT00915018
  • Phase 2
    Completed

    Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer

    neratinib, temsirolimus

    HER2-mutant Non-Small Cell Lung Cancer

    Enrollment
    62
    Start
    Jul 2013
    Primary Completion
    Sep 2016
    Completion
    Oct 2017
    NCT01827267
  • Phase 2
    Terminated

    Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

    Neratinib, Fulvestrant

    Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

    Enrollment
    582
    Start
    Sep 2013
    Primary Completion
    Jan 2023
    Completion
    Jan 2023
    NCT01953926
  • Phase 2
    Completed

    An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

    Neratinib, Loperamide

    Early Stage HER2+ Breast Cancer

    Enrollment
    563
    Start
    Feb 2015
    Primary Completion
    Apr 2021
    Completion
    Apr 2021
    NCT02400476
  • Phase 2
    Completed

    A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib

    Neratinib, Capecitabine

    HER2 Amplified Breast Cancer

    Enrollment
    6
    Start
    Jun 2020
    Primary Completion
    Dec 2021
    Completion
    Dec 2021
    NCT04366713
  • Phase 2
    Recruiting

    A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer

    Alisertib

    Small Cell Lung Cancer

    Enrollment
    120
    Start
    Feb 2024
    Primary Completion
    Oct 2027est.
    Completion
    Apr 2028est.
    NCT06095505
  • Phase 2
    Recruiting

    A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

    Alisertib, Endocrine therapy

    Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer +1

    Enrollment
    225
    Start
    Nov 2024
    Primary Completion
    Dec 2027est.
    Completion
    Jun 2029est.
    NCT06369285
  • Phase 2
    Recruiting

    A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)

    Alisertib, Alisertib

    Small Cell Lung Cancer ( SCLC )

    Enrollment
    50
    Start
    Sep 2026
    Primary Completion
    Mar 2028est.
    Completion
    Sep 2028est.
    NCT07465757
  • Phase 1/2
    Completed

    A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer

    HKI-272, trastuzumab

    Advanced Breast Cancer

    Enrollment
    45
    Start
    Apr 2007
    Primary Completion
    Jul 2009
    Completion
    Mar 2018
    NCT00398567
  • Phase 1/2
    Completed

    A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer

    HKI-272, Paclitaxel

    Advanced Breast Cancer, Advanced Malignant Solid Tumors +1

    Enrollment
    110
    Start
    Sep 2007
    Primary Completion
    May 2011
    Completion
    Feb 2018
    NCT00445458
  • Phase 1/2
    Completed

    Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer

    neratinib, vinorelbine

    Breast Cancer, Advanced Malignant Solid Tumors

    Enrollment
    92
    Start
    Apr 2008
    Primary Completion
    Oct 2009
    Completion
    Jun 2018
    NCT00706030
  • Phase 1/2
    Completed

    Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer

    Neratinib, Capecitabine

    Breast Cancer

    Enrollment
    105
    Start
    Dec 2008
    Primary Completion
    Nov 2010
    Completion
    Jun 2018
    NCT00741260
  • Phase 1/2
    Completed

    Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer

    Temsirolimus, Neratinib

    Breast Cancer

    Enrollment
    99
    Start
    Apr 2010
    Primary Completion
    Jul 2016
    Completion
    Jul 2016
    NCT01111825
  • Phase 1
    Completed

    Study Evaluating HKI-272 in Tumors

    neratinib

    Breast Neoplasms

    Enrollment
    73
    Start
    Nov 2003
    Primary Completion
    Jan 2007
    Completion
    Jan 2007
    NCT00146172
  • Phase 1
    Completed

    Study Evaluating HKI-272 Administered to Healthy Subjects

    neratinib

    Healthy

    Enrollment
    56
    Start
    Jul 2006
    Primary Completion
    Dec 2006
    Completion
    Dec 2006
    NCT00366600
  • Phase 1
    Completed

    HKI-272 Ketoconazole Drug Interaction Study

    neratinib

    Healthy

    Enrollment
    24
    Start
    Oct 2006
    Primary Completion
    -
    Completion
    Nov 2006
    NCT00380328
  • Phase 1
    Completed

    A Study Of The Safety And Tolerability Of HKI-272 Administered Orally To Japanese Subjects With Advanced Solid Tumors

    neratinib

    Tumors

    Enrollment
    21
    Start
    Nov 2006
    Primary Completion
    Mar 2009
    Completion
    Mar 2009
    NCT00397046
  • Phase 1
    Completed

    Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects

    neratinib

    Healthy

    Enrollment
    36
    Start
    Jul 2007
    Primary Completion
    -
    Completion
    Sep 2007
    NCT00498745
  • Phase 1
    Completed

    Study Evaluating Oral Administrations of HKI-272 in Healthy Male Subjects

    neratinib

    Healthy

    Enrollment
    6
    Start
    Mar 2008
    Primary Completion
    Apr 2008
    Completion
    Apr 2008
    NCT00550212
  • Phase 1
    Completed

    Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization)

    neratinib, Moxifloxacin

    Breast Cancer

    Enrollment
    60
    Start
    May 2008
    Primary Completion
    Jul 2008
    Completion
    Jul 2008
    NCT00708903

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