PBYI Puma Biotechnology Inc

11.2
+0.01  (+0%)
Previous Close 11.19
Open 11.17
Price To Book 20
Market Cap 435,647,464
Shares 38,897,095
Volume 110,643
Short Ratio
Av. Daily Volume 1,422,937

NewsSee all news

  1. Puma Biotechnology Announces U.S. FDA Acceptance of Supplemental New Drug Application for Neratinib to Treat HER2-Positive Metastatic Breast Cancer

    Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for neratinib in

  2. Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)

    Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced that on September 4, 2019 the Compensation Committee of Puma's Board of Directors approved the grant of inducement restricted stock unit

  3. Puma Biotechnology Licensing Partner Pint Pharma Receives Marketing Authorization for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage Hormone Receptor Positive, HER2-Positive Breast Cancer

    First regulatory approval of NERLYNX in Latin America. NERLYNX is the first approved therapy to reduce the risk of invasive disease recurrence in HER2-positive breast cancer patients following trastuzumab-based

  4. Puma Biotechnology to Present at the H.C. Wainwright 21st Annual Global Investment Conference

    Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 9:35

  5. FDA Grants Orphan Drug Designation to Puma Biotechnology's NERLYNX® for the Treatment of Breast Cancer Patients with Brain Metastases

    Puma Biotechnology, Inc. (NASDAQ:PBYI) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NERLYNX® (neratinib) for the treatment of breast cancer patients with brain

Drug Information

Drug catalyst information is displayed when you hover over the stage bar graph.

Phase 2 data released at ASCO June 3, 2017.
Neratinib
HER2-positive metastatic breast cancer patients with brain metastases
Phase 2 biomarker data released December 7, 2016.
PB272 (NSABP FB-7)
Neoadjuvant treatment for patients with HER2-positive breast cancer
Phase 2 additional data presented July 3, 2019 at ESMO. Median PFS 1.8 months. 2/20 partial responses. 4/20 stable disease.
Neratinib SUMMIT
HER2 non-amplified breast cancer that has a HER2 mutation
Phase 2 additional data due 4Q 2019.
Neratinib monotherapy with high dose loperamide prophylaxis - CONTROL
Extended adjuvant treatment of early stage HER2-positive breast cancer
PDUFA date late-April 2020.
Neratinib - NALA
Third-line HER2-positive metastatic breast cancer
Phase 2 completed.
Neratinib - NEfERTT trial
HER2-positive breast cancer first line
Approval announced July 17, 2017. Advisory Committee Meeting May 24, 2017 voted 12-4 in favor of recommending approval.
Neratinib (NERLYNX)
Extended adjuvant HER2-positive early stage breast cancer
Phase 1/2 interim data presented at ASCO June 2018. 9 PRs, 3CRs out of 20 patients.
Neratinib plus Kadcyla (T-DM1)
HER2-positive metastatic breast cancer

Latest News

  1. Puma Biotechnology Announces U.S. FDA Acceptance of Supplemental New Drug Application for Neratinib to Treat HER2-Positive Metastatic Breast Cancer

    Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for neratinib in

  2. Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)

    Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced that on September 4, 2019 the Compensation Committee of Puma's Board of Directors approved the grant of inducement restricted stock unit

  3. Puma Biotechnology Licensing Partner Pint Pharma Receives Marketing Authorization for NERLYNX® (neratinib) for Extended Adjuvant Treatment of Early Stage Hormone Receptor Positive, HER2-Positive Breast Cancer

    First regulatory approval of NERLYNX in Latin America. NERLYNX is the first approved therapy to reduce the risk of invasive disease recurrence in HER2-positive breast cancer patients following trastuzumab-based

  4. Puma Biotechnology to Present at the H.C. Wainwright 21st Annual Global Investment Conference

    Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 9:35

  5. FDA Grants Orphan Drug Designation to Puma Biotechnology's NERLYNX® for the Treatment of Breast Cancer Patients with Brain Metastases

    Puma Biotechnology, Inc. (NASDAQ:PBYI) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NERLYNX® (neratinib) for the treatment of breast cancer patients with brain