Puma Biotechnology, Inc.’s (PBYI - Free Report) shares were up 9.1% after the company announced that its Marketing Authorization Application (MAA) for neratinib has been validated and is now under assessment by the European Medicines Agency (EMA).
The company is looking to get neratinib approved as the extended adjuvant treatment of HER2-positive early-stage breast cancer, previously treated with Roche Holding AG’s (RHHBY - Free Report) Herceptin (trastuzumab)-based adjuvant therapy.
We note that in Jun 2016, the company submitted a regulatory application in the EU based on the results from a phase III (ExteNET) study, which demonstrated a statistically significant reduction in the risk of invasive disease recurrence or death, in comparison to placebo, thereby meeting the primary endpoint.
We remind investors that last month, the company also submitted a New Drug Application (NDA) for neratinib in the U.S. for the extended adjuvant treatment of patients with early-stage HER2-overexpressed/amplified breast cancer, who have received prior adjuvant Herceptin-based therapy.
Note that Puma Biotech is currently evaluating neratinib in several breast cancer studies and expects to report data from these studies throughout the second half of 2016 and beyond. Although the company is exploring the possibility of developing an intravenous formulation of neratinib, it is currently focused on the development of an oral formulation of the candidate.
Meanwhile, Puma Biotech believes that neratinib can also be developed for the treatment of other cancers, including non-small cell lung cancer (NSCLC) and other tumor types that over-express or have a mutation in HER2.
Drugs currently approved to treat breast cancer include Faslodex, Ibrance, Herceptin and Femara among others.
Given that Puma Biotech has no approved product in its portfolio at the moment and neratinib is its lead pipeline candidate, we expect investor focus to remain on updates pertaining to its development.
Puma Biotech currently carries a Zacks Rank #2 (Buy). A couple of other favorably placed stocks in the health care sector include Actelion Ltd. and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).
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Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
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Puma Biotechnology, Inc.’s (PBYI - Free Report) shares were up 9.1% after the company announced that its Marketing Authorization Application (MAA) for neratinib has been validated and is now under assessment by the European Medicines Agency (EMA).
The company is looking to get neratinib approved as the extended adjuvant treatment of HER2-positive early-stage breast cancer, previously treated with Roche Holding AG’s (RHHBY - Free Report) Herceptin (trastuzumab)-based adjuvant therapy.
We note that in Jun 2016, the company submitted a regulatory application in the EU based on the results from a phase III (ExteNET) study, which demonstrated a statistically significant reduction in the risk of invasive disease recurrence or death, in comparison to placebo, thereby meeting the primary endpoint.
We remind investors that last month, the company also submitted a New Drug Application (NDA) for neratinib in the U.S. for the extended adjuvant treatment of patients with early-stage HER2-overexpressed/amplified breast cancer, who have received prior adjuvant Herceptin-based therapy.
Note that Puma Biotech is currently evaluating neratinib in several breast cancer studies and expects to report data from these studies throughout the second half of 2016 and beyond. Although the company is exploring the possibility of developing an intravenous formulation of neratinib, it is currently focused on the development of an oral formulation of the candidate.
Meanwhile, Puma Biotech believes that neratinib can also be developed for the treatment of other cancers, including non-small cell lung cancer (NSCLC) and other tumor types that over-express or have a mutation in HER2.
Drugs currently approved to treat breast cancer include Faslodex, Ibrance, Herceptin and Femara among others.
Given that Puma Biotech has no approved product in its portfolio at the moment and neratinib is its lead pipeline candidate, we expect investor focus to remain on updates pertaining to its development.
Puma Biotech currently carries a Zacks Rank #2 (Buy). A couple of other favorably placed stocks in the health care sector include Actelion Ltd. and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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