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Clovis Up More Than 50% in 2017: What's Driving the Stock?
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Shares of Clovis Oncology, Inc. have been on a roll. This small biotech company is up 51.2% so far this year, outperforming the 3.5% increase registered by the industry during this period.
Let’s analyze the factors that have driven the stock’s rally so far.
The company’s only marketed drug, Rubraca, had received accelerated approval in December 2016. The drug is a PARP inhibitor and is approved as monotherapy for the treatment of advanced ovarian cancer in third or later line settings.
Although the drug saw slower adoption in the third quarter of 2017 amid competition from Tesaro’s Zejula and AstraZeneca’s (AZN - Free Report) Lynparza, sales grew 15% sequentially. The company has also made efforts to increase patient awareness and accessibility of the drug. The company had 1100 new patients on therapy in the period. The drug registered sales of $38.5 million in the first nine months.
The patients are selected for therapy based on an FDA-approved companion diagnostic for Rubraca.
Data from a confirmatory study, ARIEL 3, which was conducted to convert the accelerated approval to continued approval of Rubraca showed promising progression-free survival in patients. The company filed a supplemental new drug application (sNDA) to the FDA in October 2017 based on ARIEL-3 data to expand Rubraca’s label to include second-line or later maintenance indication for advanced ovarian cancer. The company believes that the label expansion will increase patient population by at least four times.
The FDA has accepted the sNDA under priority review on Dec 5, 2017. A decision is expected in April next year.
Meanwhile, the other phase III confirmatory study - ARIEL4 - is evaluating Rubraca versus chemotherapy in patients who have failed two prior lines of therapy. Rubraca is also under review in the EU for a comparable ovarian cancer indication. An approval is expected in EU in the first quarter of 2018 and Clovis is establishing the commercial infrastructure for the same.
Clovis is also developing Rubraca in other cancer indications either as monotherapy or in combination with other agents. Two separate studies are evaluating Rubraca in combination with Roche’s Tecentriq in gynecologic cancers or Bristol-Myers Squibb Company’s (BMY - Free Report) Opdivo in ovarian, breast and prostate cancer.
It's hard to believe, even for us at Zacks. But while the market gained +18.8% from 2016 - Q1 2017, our top stock-picking screens have returned +157.0%, +128.0%, +97.8%, +94.7%, and +90.2% respectively.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - Q1 2017, the composite yearly average gain for these strategies has beaten the market more than 11X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
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Clovis Up More Than 50% in 2017: What's Driving the Stock?
Shares of Clovis Oncology, Inc. have been on a roll. This small biotech company is up 51.2% so far this year, outperforming the 3.5% increase registered by the industry during this period.
Let’s analyze the factors that have driven the stock’s rally so far.
The company’s only marketed drug, Rubraca, had received accelerated approval in December 2016. The drug is a PARP inhibitor and is approved as monotherapy for the treatment of advanced ovarian cancer in third or later line settings.
Although the drug saw slower adoption in the third quarter of 2017 amid competition from Tesaro’s Zejula and AstraZeneca’s (AZN - Free Report) Lynparza, sales grew 15% sequentially. The company has also made efforts to increase patient awareness and accessibility of the drug. The company had 1100 new patients on therapy in the period. The drug registered sales of $38.5 million in the first nine months.
The patients are selected for therapy based on an FDA-approved companion diagnostic for Rubraca.
Data from a confirmatory study, ARIEL 3, which was conducted to convert the accelerated approval to continued approval of Rubraca showed promising progression-free survival in patients. The company filed a supplemental new drug application (sNDA) to the FDA in October 2017 based on ARIEL-3 data to expand Rubraca’s label to include second-line or later maintenance indication for advanced ovarian cancer. The company believes that the label expansion will increase patient population by at least four times.
The FDA has accepted the sNDA under priority review on Dec 5, 2017. A decision is expected in April next year.
Meanwhile, the other phase III confirmatory study - ARIEL4 - is evaluating Rubraca versus chemotherapy in patients who have failed two prior lines of therapy. Rubraca is also under review in the EU for a comparable ovarian cancer indication. An approval is expected in EU in the first quarter of 2018 and Clovis is establishing the commercial infrastructure for the same.
Clovis is also developing Rubraca in other cancer indications either as monotherapy or in combination with other agents. Two separate studies are evaluating Rubraca in combination with Roche’s Tecentriq in gynecologic cancers or Bristol-Myers Squibb Company’s (BMY - Free Report) Opdivo in ovarian, breast and prostate cancer.
Clovis Oncology, Inc. Price
Clovis Oncology, Inc. Price | Clovis Oncology, Inc. Quote
Clovis has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +18.8% from 2016 - Q1 2017, our top stock-picking screens have returned +157.0%, +128.0%, +97.8%, +94.7%, and +90.2% respectively.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - Q1 2017, the composite yearly average gain for these strategies has beaten the market more than 11X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>