Pfizer Inc. (PFE - Free Report) announced that two additional phase III studies (SPIRE-HR and SPIRE-FH) on its PCSK9 inhibitor, bococizumab, have met the primary endpoint in patients at high and very high risk of cardiovascular events.
The SPIRE-HR study was conducted on adults with primary hyperlipidemia or mixed dyslipidemia at high and very high risk of cardiovascular events, receiving a maximally tolerated dose of statin therapy whose LDL-C ≥70 mg/dL. On the other hand, the SPIRE-FH study involved adults with heterozygous familial hypercholesterolemia (HeFH) who were at high and very high risk of cardiovascular events, receiving a maximally tolerated dose of statin.
Data from the studies demonstrated a significant reduction in the percent change from baseline in LDL-C at 12 weeks compared to placebo. In both the studies, bococizumab was found to be generally safe and well tolerated.
SPIRE-HR and SPIRE-FH are the third and fourth successful studies in Pfizer’s phase III program (SPIRE - Studies of PCSK9 Inhibition and the Reduction of vascular Events) on bococizumab. The SPIRE program consists of six lipid-lowering studies – SPIRE-SI, SPIRE-AI, SPIRE-HR, SPIRE-FH, SPIRE-LL and SPIRE-LDL – and two cardiovascular outcomes studies – SPIRE-1 and SPIRE-2.
Two of the remaining SPIRE lipid-lowering studies are expected to be completed later this year. Meanwhile, full results from SPIRE-HR and SPIRE-FH studies will be presented at an upcoming scientific meeting and will be used for regulatory filing for bococizumab.
We note that PCSK9 is a protein that lowers the liver's ability to remove ‘bad’ cholesterol (LDL-C) from the blood. Although the market represents huge commercial potential, Pfizer will be a late entrant in the market given the presence of Regeneron Pharmaceuticals, Inc. (REGN - Free Report) /Sanofi’s (SNY - Free Report) Praluent and Amgen Inc.’s (AMGN - Free Report) Repatha.
Currently, Pfizer carries a Zacks Rank #1 (Strong Buy) while Amgen is a Zacks Rank #2 (Buy) stock in the health care sector.
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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.
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Pfizer Inc. (PFE - Free Report) announced that two additional phase III studies (SPIRE-HR and SPIRE-FH) on its PCSK9 inhibitor, bococizumab, have met the primary endpoint in patients at high and very high risk of cardiovascular events.
The SPIRE-HR study was conducted on adults with primary hyperlipidemia or mixed dyslipidemia at high and very high risk of cardiovascular events, receiving a maximally tolerated dose of statin therapy whose LDL-C ≥70 mg/dL. On the other hand, the SPIRE-FH study involved adults with heterozygous familial hypercholesterolemia (HeFH) who were at high and very high risk of cardiovascular events, receiving a maximally tolerated dose of statin.
Data from the studies demonstrated a significant reduction in the percent change from baseline in LDL-C at 12 weeks compared to placebo. In both the studies, bococizumab was found to be generally safe and well tolerated.
SPIRE-HR and SPIRE-FH are the third and fourth successful studies in Pfizer’s phase III program (SPIRE - Studies of PCSK9 Inhibition and the Reduction of vascular Events) on bococizumab. The SPIRE program consists of six lipid-lowering studies – SPIRE-SI, SPIRE-AI, SPIRE-HR, SPIRE-FH, SPIRE-LL and SPIRE-LDL – and two cardiovascular outcomes studies – SPIRE-1 and SPIRE-2.
Two of the remaining SPIRE lipid-lowering studies are expected to be completed later this year. Meanwhile, full results from SPIRE-HR and SPIRE-FH studies will be presented at an upcoming scientific meeting and will be used for regulatory filing for bococizumab.
We note that PCSK9 is a protein that lowers the liver's ability to remove ‘bad’ cholesterol (LDL-C) from the blood. Although the market represents huge commercial potential, Pfizer will be a late entrant in the market given the presence of Regeneron Pharmaceuticals, Inc. (REGN - Free Report) /Sanofi’s (SNY - Free Report) Praluent and Amgen Inc.’s (AMGN - Free Report) Repatha.
Currently, Pfizer carries a Zacks Rank #1 (Strong Buy) while Amgen is a Zacks Rank #2 (Buy) stock in the health care sector.
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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