Log in
Lost password
Become a member for free
Sign up
Sign up
Dynamic quotes 

4-Traders Homepage  >  Equities  >  Nyse  >  Puma Biotechnology Inc    PBYI

News SummaryMost relevantAll newsSector news 
The feature you requested does not exist. However, we suggest the following feature:

PUMA BIOTECHNOLOGY : Other Events (form 8-K)

11/30/2015 | 04:33pm US/Eastern

Item 8.01 Other Events.

On November 30, 2015, Puma Biotechnology, Inc. (the "Company") announced that based on its recent meeting with the European Medicines Agency ("EMA"), the Company plans to submit a Marketing Authorisation Application ("MAA") for the approval of neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer in patients who have previously been treated with a trastuzumab-containing regimen in the first half of 2016.

The Company recently conducted an MAA pre-submission meeting with the EMA. The purpose of this meeting was to provide the EMA with data from neratinib's non-clinical and clinical development programs that will form the basis of MAA sections for EMA review and approval. The data discussed with the EMA included non-clinical data (pharmacology, toxicology and carcinogenicity) and clinical trial data including the data from the Phase III trial of neratinib in the extended adjuvant treatment of HER2-positive early stage breast cancer (ExteNET trial). Upon review of this material, the EMA assessed that there were no critical concerns that would prevent the Company from submitting a complete MAA for European centralized review in support of neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer in patients who have previously been treated with a trastuzumab-containing regimen.

Forward-Looking Statements:

This Current Report on Form 8-K contains forward-looking statements, including, but not limited to, statements regarding the development of the Company's drug candidates and the timing of regulatory filings. All forward-looking statements included in this Current Report on Form 8-K involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing; the Company's dependence on PB272, which is still under development and may never receive regulatory approval; the challenges associated with conducting and enrolling clinical trials; the risk that the results of clinical trials may not support the Company's drug candidate claims; even if approved, the risk that physicians and patients may not accept or use the Company's products; the Company's reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates; the Company's dependence on licensed intellectual property; and the other risk factors disclosed in the periodic reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company's Annual Report on Form 10-K for the year ended December 31, 2014 and any subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.


© Edgar Online, source Glimpses

React to this article
04:33p PUMA BIOTECHNOLOGY : Other Events (form 8-K)
04:12p PUMA BIOTECHNOLOGY : Provides Update from Meeting with European Medicines Agency
11/19 PUMA BIOTECHNOLOGY : Reports Third Quarter 2015 Financial Results
11/19 PUMA BIOTECHNOLOGY : Other Events (form 8-K)
11/13 PUMA BIOTECHNOLOGY : to Present Data at the San Antonio Breast Cancer Symposium ..
11/12 PUMA BIOTECHNOLOGY : to Present at Credit Suisse Healthcare Conference
11/09 PUMA BIOTECHNOLOGY : Biotech reports 3Q loss
11/09 PUMA BIOTECHNOLOGY : Results of Operations and Financial Condition, Financial St..
11/09 PUMA BIOTECHNOLOGY : Reports Third Quarter 2015 Financial Results
News chart
Full-screen chart
Income Statement Evolution
More Financials