• Puma Biotechnology (PBYI) PDUFA of Neratinib + Trastuzumab for HER2+ Breast Cancer

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    Clinical and Regulatory
    Event Type: PDUFA
    Timing: Q3 2017
    Designation(s): None

    This event is set for a broad date range and therefore the exact timing is unknown. This adds a degree of risk.
    FDA special designations may increase the likelihood of success and decrease the time to approval.
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    Disease and Treatment
    Disease: Oncology
    Indication: HER2-positive Breast Cancer
    Lead Indication?: Yes
    Treatment Name: Neratinib + Trastuzumab

    Likelihood of event success varies depending on disease, treatment and lead indication classification.
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    Company Information
    Co. Name: Puma Biotechnology
    Stock Symbol: PBYI
    Shares Traded: NYSE

    The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
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    Event Status
    Event Outcome: Ongoing
    Event Discussion: Forums
    Event Announcement(s): http://seekingalpha.com/news/3209758-fda-accepts-puma-bios-nda-lead-product-candidate-neratinib-breast-cancer-shares-7-percent
    Partnership: Yes

    Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
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    Detailed Event Description from Company Announcement


    The FDA accepts for review Puma Biotechnology's (NYSE:PBYI) New Drug Application (NDA) seeking approval of neratinib (PB272) for the extended adjuvant treatment of patients with early-stage HER2+ breast cancer who have been previously treated with adjuvant trastuzumab-based therapy (Roche'sHerceptin)... The specific FDA action date (PDUFA) is not provided, but should be in July 2017


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