Puma Biotechnology Submits a Supplemental New Drug Application to U.S. FDA for Neratinib to Treat HER2-Positive Metastatic 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--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease).Neratinib was originally approved by the U.S. Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® tablets. In September 2018 NERLYNX was granted marketing authorization by the European Commission for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and are less than one year from completion of
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News
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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