Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 

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

Delayed Quote. Delayed  - 07/29 09:42:01 pm
49.71 USD   +2.45%
07/21 PUMA BIOTECHNOL : Announces Interim 5-Year Disease Free Survival Dat..
07/21 PUMA BIOTECHNOL : Submits New Drug Application for PB272 (Neratinib)..
07/08 PUMA BIOTECHNOL : What Investors are Making of These Biotech Stocks?..
SummaryQuotesChartsNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsSector news 
The feature you requested does not exist. However, we suggest the following feature:

Puma Biotechnology : Submits New Drug Application for PB272 Neratinib to U.S. FDA for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast...

share with twitter share with LinkedIn share with facebook
share via e-mail
0
07/28/2016 | 07:40pm CEST

Puma Biotechnology Submits New Drug Application for PB272 Neratinib to U.S. FDA for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

By a News Reporter-Staff News Editor at Biotech Week -- Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate PB272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin®)-based therapy (see also Biotechnology Companies).

"We are very pleased to announce this important regulatory milestone," said Alan H. Auerbach, Chief Executive Officer and President of Puma. "Although the use of trastuzumab in the adjuvant setting has led to a reduction in disease recurrence in patients with early stage HER2-positive breast cancer, there remains an unmet clinical need to further reduce the risk of recurrence and improve outcome following trastuzumab therapy. We believe that neratinib may be able to provide this type of improvement to further help patients with this disease. We look forward to working with the FDA during their review of this submission."

The submission is supported by the results of the ExteNET Phase III study, in which treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.67, p = 0.009). The 2-year invasive disease free survival (DFS) rate for the neratinib arm was 93.9% and the 2-year invasive DFS rate for the placebo arm was 91.6%. For the pre-defined subgroup of patients with hormone receptor positive disease, the results of the trial demonstrated that treatment with neratinib resulted in a 49% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.51, p = 0.001). For the patients with hormone receptor positive disease, the 2-year invasive DFS rate for the neratinib arm was 95.4% and the 2-year invasive DFS rate for the placebo arm was 91.2%.

Results of the study were published online in The Lancet Oncology on February 10, 2016.

The most frequently observed adverse event for the neratinib-treated patients was diarrhea, with approximately 39.9% of the neratinib-treated patients experiencing grade 3 or higher diarrhea (1 patient (0.1%) had grade 4 diarrhea). Patients who received neratinib in the ExteNET trial did not receive any prophylaxis with antidiarrheal agents to prevent the neratinib-related diarrhea. In patients with HER2-positive early stage breast cancer who have previously been treated with adjuvant trastuzumab and received anti-diarrheal prophylaxis with loperamide, interim results of a Phase II study of neratinib monotherapy demonstrated that treatment with prophylactic loperamide reduced the rate of grade 3 or higher diarrhea to between 13.0% and 18.5%. About ExteNET The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in women with early stage HER2-positive breast cancer. The trial randomized 2,840 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomized to receive extended adjuvant treatment with either neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of two years after randomization in the trial. The primary endpoint of the trial was invasive DFS. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidates-PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2.

Further information about Puma Biotechnology can be found at www.pumabiotechnology.com. View source version on businesswire.com: http://www.businesswire.com/news/home/20160721006287/en/

Keywords for this news article include: Antineoplastic Monoclonal Antibodies, Drugs, Therapy, Diarrhea, Genetics, Hormones, Oncology, Placebos, FDA Actions, Trastuzumab, Breast Cancer, Women's Health, HER2 Inhibitors, Medical Devices, Biopharmaceuticals, Biotechnology Companies, Puma Biotechnology Inc., Tyrosine Kinase Inhibitors.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2016, NewsRx LLC

(c) 2016 NewsRx LLC, source Health Newsletters

share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on PUMA BIOTECHNOLOGY INC
07/28 PUMA BIOTECHNOLOGY : Submits New Drug Application for PB272 Neratinib to U.S. FD..
07/28 PUMA BIOTECHNOLOGY : Announces Interim 5-Year Disease Free Survival Data from Ph..
07/22 PUMA BIOTECHNOLOGY, INC. : Other Events, Financial Statements and Exhibits (form..
07/21 PUMA BIOTECHNOLOGY : Announces Interim 5-Year Disease Free Survival Data from Ph..
07/21 PUMA BIOTECHNOLOGY : Submits New Drug Application for PB272 (Neratinib) to U.S. ..
07/14 PUMA BIOTECHNOLOGY : Announces I-SPY 2 Phase II Study of Neratinib Published in ..
07/08 PUMA BIOTECHNOLOGY : What Investors are Making of These Biotech Stocks? - Grifol..
07/07 PUMA BIOTECHNOLOGY : Announces I-SPY 2 Phase II Study of Neratinib Published in ..
07/06 PUMA BIOTECHNOLOGY, INC. : Other Events (form 8-K)
06/28 PUMA BIOTECHNOLOGY, INC. : Other Events (form 8-K)
More news
Sector news : Biotechnology & Medical Research - NEC
02:26pDJMerck Revenue Rises on Cancer, Hepatitis Treatments
02:10pDJMERCK : Revenue Rises on Cancer, Hepatitis Treatments
08:56aDJSanofi Profit Down as Diabetes Drug Sales Slip
07/28DJCELGENE : Lifts Guidance as Revlimid Sales Rise -- Update
07/28DJU.S. HOT STOCKS : Hot Stocks to Watch
More sector news : Biotechnology & Medical Research - NEC
News from SeekingAlpha
07/22 Puma Files, And The Battle Begins
07/22 Midday Gainers / Losers
07/22 HEALTHCARE - TOP 5 GAINERS / LOSERS : 00 am
07/22 PREMARKET GAINERS / LOSERS AS OF 9 : 10 am
07/21 Puma Bio submits NDA in U.S. for neratinib; shares up 18% after hours
Advertisement
Financials ($)
Sales 2016 -
EBIT 2016 -298 M
Net income 2016 -296 M
Finance 2016 185 M
Yield 2016 -
P/E ratio 2016 -
P/E ratio 2017
EV / Sales 2016 0
EV / Sales 2017 50,8x
Capitalization 1 577 M
More Financials
Chart PUMA BIOTECHNOLOGY INC
Duration : Period :
Puma Biotechnology Inc Technical Analysis Chart | PBYI | US74587V1070 | 4-Traders
Full-screen chart
Technical analysis trends PUMA BIOTECHNOLOG...
Short TermMid-TermLong Term
TrendsBullishNeutralBearish
Technical analysis
Income Statement Evolution
More Financials
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 7
Average target price 68,6 $
Spread / Average Target 41%
Consensus details
EPS Revisions
More Estimates Revisions
Managers
NameTitle
Alan H. Auerbach Chairman, President, CEO & Secretary
Charles R. Eyler Treasurer & Senior VP-Finance & Administration
Richard Paul Bryce Senior VP-Clinical Research & Development
Jay M. Moyes Independent Director
Troy E. Wilson Independent Director
More about the company
Sector and Competitors
1st jan.Capitalization (M$)
PUMA BIOTECHNOLOGY INC-38.11%1 577
INCYTE CORPORATION-18.75%16 533
CELLTRION, INC.--.--%10 724
LONZA GROUP AG12.20%9 855
QUINTILES TRANSNATIONA..13.49%9 232
ALKERMES PLC-39.37%7 276
More Results