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Puma (PBYI) Q1 Loss Narrows, Focus Remains on Neratinib
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Puma Biotechnology, Inc. (PBYI - Free Report) reported a first-quarter 2017 loss of $1.97 per share (including the impact of stock-based compensation expenses), narrower than the Zacks Consensus Estimate of a loss of $2.08 and the year-ago loss of $2.19.
So far this year, Puma’s shares have underperformed the Zacks classified Medical-Biomedical and Genetics industry. Specifically, the company’s shares have remained flat while the industry registered an increase of 2.8%.
With no approved products in Puma’s portfolio at the moment, the company does not generate revenues yet.
In the first quarter, research and development (R&D) expenses were $54.8 million, down 9% from the year-ago quarter due to lower clinical trial costs. General and administrative expenses however increased 67.3% year over year to $18.4 million.
Focus on Neratinib
Puma has made significant progress with its lead candidate, neratinib. The candidate is currently under review in both the U.S. and the EU for the extended adjuvant treatment of HER2-positive early-stage breast cancer in patients who have previously been treated with Herceptin-based adjuvant therapy. Last month, Puma announced that an FDA Advisory Committee will review the NDA for neratinib at a meeting scheduled on May 24.
Several additional studies on neratinib targeting different types of breast cancer patient populations are currently underway.
Last month, Puma presented interim phase I/II data from the NSABP FB-10 trial of neratinib plus Kadcyla (T-DM1) in HER2-positive metastatic breast cancer at the annual meeting of the American Association for Cancer Research (AACR). Initial findings from the study were encouraging. Data from the study showed high response rates of the T-DM1 and neratinib combination in this patient population who were previously treated with both Roche Holding AG’s (RHHBY - Free Report) cancer drugs Herceptin and Perjeta. The company said it will enroll patients at the 160 mg dose to further evaluate the impact in this patient population.
Phase II data from the SUMMIT study evaluating neratinib as a single agent in patients with solid tumors who have an activating HER2 mutation (basket study) were also presented at the AACR meeting. In January this year, Puma announced it has expanded the fourth cohort of the SUMMIT study. The expanded cohort includes patients with metastatic cervical cancer and whose tumors have a HER2 mutation.
In several of the cohorts in the study, neratinib showed signs of clinical activity. The safety profile of the drug was manageable. The company plans to advance the targeted compound into further clinical development in multiple HER2 mutant tumor types, both as monotherapy and in combination with other drugs.
At AACR, data were also presented from the CONTROL study evaluating the use of antidiarrheal prophylaxis to reduce diarrhea with neratinib in the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab-based therapy.
Puma anticipates more data updates in the ongoing quarter. These include additional data from the phase III study on neratinib in third-line HER2-positive metastatic breast cancer patients and data from a phase II study on neratinib in HER2-positive metastatic breast cancer patients with brain metastases.
Puma Biotechnology Inc Price, Consensus and EPS Surprise
Better-ranked stocks in the pharmaceutical sector are Aeglea BioTherapeutics and Akari Therapeutics, Plc (AKTX - Free Report) . While Akari Therapeutics sports a Zacks Rank #1 (Strong Buy), Aeglea BioTherapeutics has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Shares of Aeglea have increased 44.8% this year so far while loss estimates for 2017 have narrowed almost 32% in the past 30 days.
Shares of Akari Therapeutics have risen 57.9% this year so far.
The Best & Worst of Zacks
Today you are invited to download the full, up-to-the-minute list of 220 Zacks Rank #1 ""Strong Buys"" free of charge. From 1988 through 2015 this list has averaged a stellar gain of +25% per year. Plus, you may download 220 Zacks Rank #5 ""Strong Sells."" Even though this list holds many stocks that seem to be solid, it has historically performed 6X worse than the market. See these critical buys and sells free >>
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Puma (PBYI) Q1 Loss Narrows, Focus Remains on Neratinib
Puma Biotechnology, Inc. (PBYI - Free Report) reported a first-quarter 2017 loss of $1.97 per share (including the impact of stock-based compensation expenses), narrower than the Zacks Consensus Estimate of a loss of $2.08 and the year-ago loss of $2.19.
So far this year, Puma’s shares have underperformed the Zacks classified Medical-Biomedical and Genetics industry. Specifically, the company’s shares have remained flat while the industry registered an increase of 2.8%.
With no approved products in Puma’s portfolio at the moment, the company does not generate revenues yet.
In the first quarter, research and development (R&D) expenses were $54.8 million, down 9% from the year-ago quarter due to lower clinical trial costs. General and administrative expenses however increased 67.3% year over year to $18.4 million.
Focus on Neratinib
Puma has made significant progress with its lead candidate, neratinib. The candidate is currently under review in both the U.S. and the EU for the extended adjuvant treatment of HER2-positive early-stage breast cancer in patients who have previously been treated with Herceptin-based adjuvant therapy. Last month, Puma announced that an FDA Advisory Committee will review the NDA for neratinib at a meeting scheduled on May 24.
Several additional studies on neratinib targeting different types of breast cancer patient populations are currently underway.
Last month, Puma presented interim phase I/II data from the NSABP FB-10 trial of neratinib plus Kadcyla (T-DM1) in HER2-positive metastatic breast cancer at the annual meeting of the American Association for Cancer Research (AACR). Initial findings from the study were encouraging. Data from the study showed high response rates of the T-DM1 and neratinib combination in this patient population who were previously treated with both Roche Holding AG’s (RHHBY - Free Report) cancer drugs Herceptin and Perjeta. The company said it will enroll patients at the 160 mg dose to further evaluate the impact in this patient population.
Phase II data from the SUMMIT study evaluating neratinib as a single agent in patients with solid tumors who have an activating HER2 mutation (basket study) were also presented at the AACR meeting. In January this year, Puma announced it has expanded the fourth cohort of the SUMMIT study. The expanded cohort includes patients with metastatic cervical cancer and whose tumors have a HER2 mutation.
In several of the cohorts in the study, neratinib showed signs of clinical activity. The safety profile of the drug was manageable. The company plans to advance the targeted compound into further clinical development in multiple HER2 mutant tumor types, both as monotherapy and in combination with other drugs.
At AACR, data were also presented from the CONTROL study evaluating the use of antidiarrheal prophylaxis to reduce diarrhea with neratinib in the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab-based therapy.
Puma anticipates more data updates in the ongoing quarter. These include additional data from the phase III study on neratinib in third-line HER2-positive metastatic breast cancer patients and data from a phase II study on neratinib in HER2-positive metastatic breast cancer patients with brain metastases.
Puma Biotechnology Inc Price, Consensus and EPS Surprise
Puma Biotechnology Inc Price, Consensus and EPS Surprise | Puma Biotechnology Inc Quote
Zacks Rank & Key Picks
Puma currently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the pharmaceutical sector are Aeglea BioTherapeutics and Akari Therapeutics, Plc (AKTX - Free Report) . While Akari Therapeutics sports a Zacks Rank #1 (Strong Buy), Aeglea BioTherapeutics has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Shares of Aeglea have increased 44.8% this year so far while loss estimates for 2017 have narrowed almost 32% in the past 30 days.
Shares of Akari Therapeutics have risen 57.9% this year so far.
The Best & Worst of Zacks
Today you are invited to download the full, up-to-the-minute list of 220 Zacks Rank #1 ""Strong Buys"" free of charge. From 1988 through 2015 this list has averaged a stellar gain of +25% per year. Plus, you may download 220 Zacks Rank #5 ""Strong Sells."" Even though this list holds many stocks that seem to be solid, it has historically performed 6X worse than the market. See these critical buys and sells free >>