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Puma Soaring After Neratinib FDA Panel Win, Time to Buy?
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Shares of Puma Biotechnology, Inc. (PBYI - Free Report) have risen 35% since it announced that an FDA advisory committee recommended the approval of its lead pipeline candidate, neratinib for the treatment of some breast cancers. In fact, on Thursday, the stock hit a new 52-week high of $80.00 before closing at $78.05.
So far this year, Puma’s shares have massively outperformed the Zacks classified Medical-Biomedical and Genetics industry. Specifically, the company’s shares have risen 153.9% while the industry registered an increase of 0.6%.
On Wednesday, the company announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) committee has voted 12 - 4 to recommend approval of neratinib for the extended adjuvant treatment of HER2-positive early-stage breast cancer as a single agent.
The positive recommendation was based on data from a clinical development program that included 11 trials in breast cancer and showed that the risk-benefit profile of neratinib is favorable. Particularly, the phase III two year ExteNET study was the focus of the meeting. In the study, patients who had previously been treated with Roche Holding AG’s (RHHBY - Free Report) cancer drug Herceptin-based adjuvant therapy for a year were given continuous therapy with neratinib for another year. Data from the study showed that within two years after treatment with neratinib, the patients demonstrated a statistically significant 33% relative reduction in the risk of invasive disease recurrence.
Disease recurrence remains a grave risk in breast cancer treatment. This creates significant unmet need for medicines that can reduce the risk of recurrence. At present, there are no effective therapies for patients whose disease recurs. The benefit demonstrated by neratinib in reducing the risk of disease recurrence can create a major commercial opportunity for the small biotech company if neratinib is approved.
An approval of neratinib - which now seems highly likely with the latest FDA panel win - would be a huge boost for Puma given the immense commercial potential in the target market.
Neratinib is also under review in the EU for same indication. Meanwhile, several additional studies on neratinib targeting different types of breast cancer patient populations are currently underway. Meanwhile, Puma 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.
Other than the attractive share price performance, Puma carries a Zacks Rank #2 (Buy). Meanwhile loss estimates for both 2017 and 2018 have narrowed over the past 30 days.
VIVUS’ loss per share estimate narrowed from 50 cents to 39 cents for 2017 over the last 30 days. The company posted positive earnings surprises in each of the four trailing quarters, with an average beat of 233.69%.
Zoetis’ earnings per share estimates have risen 0.8% and 1% for 2017 and 2018, respectively, over the last 30 days. The company posted positive earnings surprises in all the four trailing quarters, with an average beat of 9.82%. Shares of the company have risen 16.9% so far this year.
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Puma Soaring After Neratinib FDA Panel Win, Time to Buy?
Shares of Puma Biotechnology, Inc. (PBYI - Free Report) have risen 35% since it announced that an FDA advisory committee recommended the approval of its lead pipeline candidate, neratinib for the treatment of some breast cancers. In fact, on Thursday, the stock hit a new 52-week high of $80.00 before closing at $78.05.
So far this year, Puma’s shares have massively outperformed the Zacks classified Medical-Biomedical and Genetics industry. Specifically, the company’s shares have risen 153.9% while the industry registered an increase of 0.6%.
On Wednesday, the company announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) committee has voted 12 - 4 to recommend approval of neratinib for the extended adjuvant treatment of HER2-positive early-stage breast cancer as a single agent.
The positive recommendation was based on data from a clinical development program that included 11 trials in breast cancer and showed that the risk-benefit profile of neratinib is favorable. Particularly, the phase III two year ExteNET study was the focus of the meeting. In the study, patients who had previously been treated with Roche Holding AG’s (RHHBY - Free Report) cancer drug Herceptin-based adjuvant therapy for a year were given continuous therapy with neratinib for another year. Data from the study showed that within two years after treatment with neratinib, the patients demonstrated a statistically significant 33% relative reduction in the risk of invasive disease recurrence.
Disease recurrence remains a grave risk in breast cancer treatment. This creates significant unmet need for medicines that can reduce the risk of recurrence. At present, there are no effective therapies for patients whose disease recurs. The benefit demonstrated by neratinib in reducing the risk of disease recurrence can create a major commercial opportunity for the small biotech company if neratinib is approved.
An approval of neratinib - which now seems highly likely with the latest FDA panel win - would be a huge boost for Puma given the immense commercial potential in the target market.
Neratinib is also under review in the EU for same indication. Meanwhile, several additional studies on neratinib targeting different types of breast cancer patient populations are currently underway. Meanwhile, Puma 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.
Other than the attractive share price performance, Puma carries a Zacks Rank #2 (Buy). Meanwhile loss estimates for both 2017 and 2018 have narrowed over the past 30 days.
Other Stocks to Consider
Stocks worth considering in the health care sector include VIVUS, Inc. , sporting a Zacks Rank #1 (Strong Buy) and Zoetis Inc. (ZTS - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks Rank #1 stocks here.
VIVUS’ loss per share estimate narrowed from 50 cents to 39 cents for 2017 over the last 30 days. The company posted positive earnings surprises in each of the four trailing quarters, with an average beat of 233.69%.
Zoetis’ earnings per share estimates have risen 0.8% and 1% for 2017 and 2018, respectively, over the last 30 days. The company posted positive earnings surprises in all the four trailing quarters, with an average beat of 9.82%. Shares of the company have risen 16.9% so far this year.
Looking for Ideas with Even Greater Upside?
Today's investment ideas are short-term, directly based on our proven 1 to 3 month indicator. In addition, I invite you to consider our long-term opportunities. These rare trades look to start fast with strong Zacks Ranks, but carry through with double and triple-digit profit potential. Starting now, you can look inside our home run, value, and stocks under $10 portfolios, plus more. Click here for a peek at this private information >>