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Puma (PBYI) Posts Wider Loss in Q3, Neratinib in Focus
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Puma Biotechnology, Inc. (PBYI - Free Report) reported a third-quarter 2016 loss of $2.02 per share (including the impact of stock-based compensation expense), wider than the Zacks Consensus Estimate of a loss of $2.00 and the year-ago loss of $1.87.
With no approved products in Puma Biotech’s portfolio at the moment, the company does not generate revenues yet.
In the third quarter, research and development (R&D) expenses were $52 million, up 0.2% from the year-ago quarter. General and administrative expenses were up by 59.1% year over year to $14 million.
Focus on Neratinib
During the quarter, Puma Biotech made significant progress with its lead candidate, neratinib. While the European Medicines Agency’s validated the company’s marketing authorization application for neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer, the FDA accepted the new drug application for the candidate for the extended adjuvant treatment of patients with early-stage HER2-overexpressed/amplified breast cancer who have been previously treated with Herceptin-based adjuvant therapy.
Several phase II studies evaluating neratinib for the treatment of breast cancer are currently underway.
The company anticipates several milestones in the current quarter and in the first half of 2017. It plans to report additional data from the phase II study on neratinib as an extended adjuvant treatment of HER2-positive early-stage breast cancer using loperamide and budesonide prophylaxis in the current quarter.
Further, the company expects to report data from the phase III study on neratinib for the third-line HER2-positive metastatic breast cancer patients in the first half of 2017.
Given that Puma Biotech has no approved products in its portfolio at the moment and neratinib is its lead candidate, we expect investor focus to remain on updates pertaining to its development.
Puma Biotech is a Zacks Rank #2 (Buy) stock. Other favorably ranked stocks in the healthcare sector include Arbutus Biopharma Corporation (ABUS - Free Report) , Heska Corporation and Anika Therapeutics Inc. (ANIK - Free Report) . Each of the stocks sports a Zacks Rank #1(Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Arbutus’ loss estimates narrowed from $2.15 to $1.80 for 2016 and from $1.96 to $1.53 for 2017 over the last 60 days. The company posted positive surprises in three of the trailing four quarters with an average beat of 59.31%.
Heska’s earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted positive surprises in all of the four trailing quarters with an average beat of 301.64%.
Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company posted positive surprises in all of the four trailing quarters with an average beat of 33.14%.
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Puma (PBYI) Posts Wider Loss in Q3, Neratinib in Focus
Puma Biotechnology, Inc. (PBYI - Free Report) reported a third-quarter 2016 loss of $2.02 per share (including the impact of stock-based compensation expense), wider than the Zacks Consensus Estimate of a loss of $2.00 and the year-ago loss of $1.87.
With no approved products in Puma Biotech’s portfolio at the moment, the company does not generate revenues yet.
In the third quarter, research and development (R&D) expenses were $52 million, up 0.2% from the year-ago quarter. General and administrative expenses were up by 59.1% year over year to $14 million.
Focus on Neratinib
During the quarter, Puma Biotech made significant progress with its lead candidate, neratinib. While the European Medicines Agency’s validated the company’s marketing authorization application for neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer, the FDA accepted the new drug application for the candidate for the extended adjuvant treatment of patients with early-stage HER2-overexpressed/amplified breast cancer who have been previously treated with Herceptin-based adjuvant therapy.
Several phase II studies evaluating neratinib for the treatment of breast cancer are currently underway.
The company anticipates several milestones in the current quarter and in the first half of 2017. It plans to report additional data from the phase II study on neratinib as an extended adjuvant treatment of HER2-positive early-stage breast cancer using loperamide and budesonide prophylaxis in the current quarter.
Further, the company expects to report data from the phase III study on neratinib for the third-line HER2-positive metastatic breast cancer patients in the first half of 2017.
Given that Puma Biotech has no approved products in its portfolio at the moment and neratinib is its lead candidate, we expect investor focus to remain on updates pertaining to its development.
PUMA BIOTECHNLG Price, Consensus and EPS Surprise
PUMA BIOTECHNLG Price, Consensus and EPS Surprise | PUMA BIOTECHNLG Quote
Zacks Rank & Stocks to Consider
Puma Biotech is a Zacks Rank #2 (Buy) stock. Other favorably ranked stocks in the healthcare sector include Arbutus Biopharma Corporation (ABUS - Free Report) , Heska Corporation and Anika Therapeutics Inc. (ANIK - Free Report) . Each of the stocks sports a Zacks Rank #1(Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Arbutus’ loss estimates narrowed from $2.15 to $1.80 for 2016 and from $1.96 to $1.53 for 2017 over the last 60 days. The company posted positive surprises in three of the trailing four quarters with an average beat of 59.31%.
Heska’s earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted positive surprises in all of the four trailing quarters with an average beat of 301.64%.
Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company posted positive surprises in all of the four trailing quarters with an average beat of 33.14%.
The Best Place to Start Your Stock Search
Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>