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Regeneron's Evinacumab Gets Breakthrough Therapy by FDA
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has granted Breakthrough Therapy Designation status to its pipeline candidate evinacumab for the treatment of hypercholesterolemia in patients with Homozygous Familial Hypercholesterolemia (HoFH). Notably, HoFH is an inherited disorder that can lead to premature heart disease due to high cholesterol.
Evinacumab is an experimental monoclonal antibody to angiopoietin-like protein 3 (ANGPTL3), which acts as an inhibitor of lipoprotein lipase and endothelial lipase, and plays a central role in lipoprotein metabolism. Regeneron’s share price shows that the company has underperformed the Zacks classified Medical - Biomedical and Genetics industry year to date. The stock is down 3.4% against the industry’s gain of 2.3%.
Last May , Regeneron presented positive data from preliminary results from a single-arm, open label, phase II proof-of-concept study on evinacumab in patients suffering from homozygous familial hypercholestrolemia at the European Atherosclerosis Society Congress.
Breakthrough Therapy designation was created to speed up the development and review of drugs that target serious or life-threatening conditions.
Interim data showed that evinacumab in combination with other lipid-lowering therapies resulted in a mean reduction in low density lipoprotein cholesterol (LDL-C) in the first 4 patients by an additional 55% at week 4 compared to baseline, which was also the primary endpoint of the study. Between these four patients, the percent reductions in LDL-C ranged from 25–90%. Overall, the patients enrolled in the study saw their mean LDL-C levels decrease from 331mg/dL at baseline to 175mg/dL at week 4.
HoFH is a rare and most severe form of hypercholesterolemia. It occurs in about one to two people per million and the untreated patients can have LDL cholesterol levels ranging from 500 to 1000 mg/dL compared to normal LDL cholesterol levels of less than 130 mg/dL. In fact, due to the high levels of LDL cholesterol, patients with HoFH are at an extreme risk of premature cardiovascular disease.
Regeneron is also planning a phase III study for evinacumab. We remind investors that in March 2017, another company Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) and its partner The Medicines Company announced positive final results from the phase II study, ORION-1, on their experimental PCSK9 inhibitor, inclisiran, which is being developed for the treatment of hypercholesterolemia. In Jan 2017, Medicines Company announced the initiation of ORION-2 for evaluating the efficacy, safety and tolerability of Inclisiran in patients with HoFH.
Regeneron currently carries a Zacks Rank #3 (Hold). A better-ranked stocks in the health care sector is Heska Corporation sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates moved up from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018, over the last 60 days. The company posted a positive earnings surprise in all of the last four quarters, with an average beat of 291.54%. Its share price has increased 45.8% year to date.
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Regeneron's Evinacumab Gets Breakthrough Therapy by FDA
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has granted Breakthrough Therapy Designation status to its pipeline candidate evinacumab for the treatment of hypercholesterolemia in patients with Homozygous Familial Hypercholesterolemia (HoFH). Notably, HoFH is an inherited disorder that can lead to premature heart disease due to high cholesterol.
Evinacumab is an experimental monoclonal antibody to angiopoietin-like protein 3 (ANGPTL3), which acts as an inhibitor of lipoprotein lipase and endothelial lipase, and plays a central role in lipoprotein metabolism. Regeneron’s share price shows that the company has underperformed the Zacks classified Medical - Biomedical and Genetics industry year to date. The stock is down 3.4% against the industry’s gain of 2.3%.
Last May , Regeneron presented positive data from preliminary results from a single-arm, open label, phase II proof-of-concept study on evinacumab in patients suffering from homozygous familial hypercholestrolemia at the European Atherosclerosis Society Congress.
Breakthrough Therapy designation was created to speed up the development and review of drugs that target serious or life-threatening conditions.
Interim data showed that evinacumab in combination with other lipid-lowering therapies resulted in a mean reduction in low density lipoprotein cholesterol (LDL-C) in the first 4 patients by an additional 55% at week 4 compared to baseline, which was also the primary endpoint of the study. Between these four patients, the percent reductions in LDL-C ranged from 25–90%. Overall, the patients enrolled in the study saw their mean LDL-C levels decrease from 331mg/dL at baseline to 175mg/dL at week 4.
HoFH is a rare and most severe form of hypercholesterolemia. It occurs in about one to two people per million and the untreated patients can have LDL cholesterol levels ranging from 500 to 1000 mg/dL compared to normal LDL cholesterol levels of less than 130 mg/dL. In fact, due to the high levels of LDL cholesterol, patients with HoFH are at an extreme risk of premature cardiovascular disease.
Regeneron is also planning a phase III study for evinacumab.
We remind investors that in March 2017, another company Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) and its partner The Medicines Company announced positive final results from the phase II study, ORION-1, on their experimental PCSK9 inhibitor, inclisiran, which is being developed for the treatment of hypercholesterolemia. In Jan 2017, Medicines Company announced the initiation of ORION-2 for evaluating the efficacy, safety and tolerability of Inclisiran in patients with HoFH.
Regeneron Pharmaceuticals, Inc. Price
Regeneron Pharmaceuticals, Inc. Price | Regeneron Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Regeneron currently carries a Zacks Rank #3 (Hold). A better-ranked stocks in the health care sector is Heska Corporation sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates moved up from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018, over the last 60 days. The company posted a positive earnings surprise in all of the last four quarters, with an average beat of 291.54%. Its share price has increased 45.8% year to date.
Zacks’ Best Private Investment Ideas
While we are happy to share many articles like this on the website, our best recommendations and most in-depth research are not available to the public. Starting today, for the next month, you can follow all Zacks' private buys and sells in real time. Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Click here for Zacks' private trades >>