Puma Biotechnology Announces Results of CHMP Oral Explanation for Neratinib for 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--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has communicated a negative trend vote after meeting with the Company today to discuss the Marketing Authorisation Application (MAA) for neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer. A negative trend vote means it is unlikely that CHMP will provide a positive opinion related to the Company’s MAA at the formal CHMP decision vote scheduled in February 2018, and that additional steps would need to be taken to gain marketing approval in Europe. CHMP indicated that, in its opinion, the benefit risk assessment is negative as the study results are based on evidence from a single pivotal trial and the 2- and 5-year invasive disease free survival (iDFS) benefits observed to-date may lack sufficient clin
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PBYI
News
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- Puma Biotechnology (NASDAQ:PBYI) shareholders have earned a 93% return over the last year [Yahoo! Finance]Yahoo! Finance
- 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