Puma Biotechnology Announces FDA Advisory Committee to Review Neratinib for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer
Puma Biotechnology Inc (PBYI)
Last puma biotechnology inc earnings: 2/20 04:07 pm
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Source: Business Wire
LOS ANGELES, Calif.--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for neratinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on May 24, 2017. Neratinib is an investigational therapy for the extended adjuvant treatment of early stage HER2-positive breast cancer that has previously been treated with a trastuzumab containing regimen. ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. Although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-bin
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News
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- Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)Business Wire
PBYI
Earnings
- 2/29/24 - Miss
PBYI
Analyst Actions
- 2/13/24 - HC Wainwright
PBYI
Sec Filings
- 3/29/24 - Form SC
- 3/19/24 - Form 4
- 3/19/24 - Form 8-K
- PBYI's page on the SEC website