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J&J's (JNJ) Phase III Study for Invokana Halted Earlier
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Johnson & Johnson (JNJ - Free Report) announced that its phase III CREDENCE study evaluating the efficacy and safety of its diabetes drug Invokana (canagliflozin) is being stopped early based on positive pre-specified efficacy data. The study was evaluating the efficacy and safety of Invokana versus placebo when used in addition to standard of care for patients with chronic kidney disease (CKD) and type II diabetes (T2D).
The decision is based on a recommendation from the study’s Independent Data Monitoring Committee (IDMC) that met to review the data during a planned interim analysis. The recommendation was based on the study which achieved pre-specified criteria for the primary composite endpoint of end-stage kidney disease, doubling of serum creatinine, and renal or cardiovascular (CV) death, when used in addition to standard of care.
Almost half of all patients with type II diabetes develop chronic kidney disease, causing a high risk of kidney failure and cardiovascular disease. Invokana has the potential to be the first new therapy in more than 15 years for slowing the progression of chronic kidney disease in patients with type II diabetes.
So far this year, Johnson & Johnson’s share price has decreased 10.7%, comparing unfavorably with the industry’s decline of 1.6%.
We also note that, recently the FDA extended the review timeline for a supplemental new drug application (sNDA) with respect to Invokana. The sNDA seeks the regulatory body’s approval for a new indication of risk reduction of cardiovascular events in type II diabetes patients who are at a risk of cardiovascular (CV) disease.
The application, also applying to Invokana’s fixed-dose combinations — Invokamet and Invokamet XR — is based on data from the phase III study CANVAS. The FDA has requested a three-month extension to provide additional time to complete the review of the application after the agency requested and received additional analyses from the company. The sNDA was submitted in October 2017 and with this extension the action date is now in October 2018.
Zacks Rank & Stocks to Consider
J&J has a Zacks Rank #3 (Hold).
Some better-ranked stocks from the same space are Illumina Inc. (ILMN - Free Report) , Alexion Pharmaceuticals Inc. and Eisai Co. . While Illumina carries a Zacks Rank #1 (Strong Buy), Eisai and Alexion carry a Zacks Rank#2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Illumina’s earnings per share estimates have increased from $4.83 to $4.87 for 2018 and from $5.57 to $5.61 for 2018 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 23.17%.
Eisai’s earnings estimates have moved up from $1.93 to $1.94 for 2018 and from $1.38 to $1.39 for 2019 over the past 60 days. The stock has rallied 70.5% so far this year.
Alexion’s stock has rallied 12.5% so far this year.
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6% and +67.1%. And this outperformance has not just been a recent phenomenon.
Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X 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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J&J's (JNJ) Phase III Study for Invokana Halted Earlier
Johnson & Johnson (JNJ - Free Report) announced that its phase III CREDENCE study evaluating the efficacy and safety of its diabetes drug Invokana (canagliflozin) is being stopped early based on positive pre-specified efficacy data. The study was evaluating the efficacy and safety of Invokana versus placebo when used in addition to standard of care for patients with chronic kidney disease (CKD) and type II diabetes (T2D).
The decision is based on a recommendation from the study’s Independent Data Monitoring Committee (IDMC) that met to review the data during a planned interim analysis. The recommendation was based on the study which achieved pre-specified criteria for the primary composite endpoint of end-stage kidney disease, doubling of serum creatinine, and renal or cardiovascular (CV) death, when used in addition to standard of care.
Almost half of all patients with type II diabetes develop chronic kidney disease, causing a high risk of kidney failure and cardiovascular disease. Invokana has the potential to be the first new therapy in more than 15 years for slowing the progression of chronic kidney disease in patients with type II diabetes.
So far this year, Johnson & Johnson’s share price has decreased 10.7%, comparing unfavorably with the industry’s decline of 1.6%.
We also note that, recently the FDA extended the review timeline for a supplemental new drug application (sNDA) with respect to Invokana. The sNDA seeks the regulatory body’s approval for a new indication of risk reduction of cardiovascular events in type II diabetes patients who are at a risk of cardiovascular (CV) disease.
The application, also applying to Invokana’s fixed-dose combinations — Invokamet and Invokamet XR — is based on data from the phase III study CANVAS. The FDA has requested a three-month extension to provide additional time to complete the review of the application after the agency requested and received additional analyses from the company. The sNDA was submitted in October 2017 and with this extension the action date is now in October 2018.
Zacks Rank & Stocks to Consider
J&J has a Zacks Rank #3 (Hold).
Some better-ranked stocks from the same space are Illumina Inc. (ILMN - Free Report) , Alexion Pharmaceuticals Inc. and Eisai Co. . While Illumina carries a Zacks Rank #1 (Strong Buy), Eisai and Alexion carry a Zacks Rank#2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Illumina’s earnings per share estimates have increased from $4.83 to $4.87 for 2018 and from $5.57 to $5.61 for 2018 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 23.17%.
Eisai’s earnings estimates have moved up from $1.93 to $1.94 for 2018 and from $1.38 to $1.39 for 2019 over the past 60 days. The stock has rallied 70.5% so far this year.
Alexion’s stock has rallied 12.5% so far this year.
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It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6% and +67.1%. And this outperformance has not just been a recent phenomenon.
Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X 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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