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Regeneron Presents Positive Phase II Data on HoFH Candidate

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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) presented positive phase II data, evaluating its investigational angiopoietin-like 3 (ANGPTL3) antibody, evinacumab at the National Lipid Association’s (NLA) Scientific Sessions. The company also announced ANGPTL3 genetics publication in the New England Journal of Medicine (NEJM).

Evinacumab is being developed 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. FDA has granted orphan drug designation for the treatment of HoFH.

Note that, 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. The candidate is being developed for the treatment of hypercholesterolemia in patients with homozygous familial hypercholesterolemia (HoFH). The FDA has granted orphan drug designation to evinacumab for the treatment of HoFH.

Shares of Regeneron have significantly outperformed the Zacks classified Medical-Biomed/Genetics industry so far this year. The stock has gained 24.8% during the period, while the broader industry witnessed an increase of 0.5%.



Important data from the phase II study showed that evinacumab in combination with other lipid-lowering therapies resulted in a mean reduction in low density lipoprotein cholesterol (LDL-C) level by an additional 49% at week 4 compared to baseline, which was also the primary endpoint of the study. Further information showed reduction in the levels of other key lipid parameters including lipoprotein(a) and triglycerides. The study did not report any adverse events, leading to discontinuation.

Additionally, the analysis published in the NEJM revealed that people with inactivating mutations of the ANGPTL3 gene have significantly led to risk-reduction in coronary artery disease (CAD) as well as decreased levels of key blood lipids including LDL-C.

We remind investors that in Apr 2017, FDA has granted a Breakthrough Therapy Designation status to evinacumab for treatment of HoFH. Meanwhile, Regeneron is also planning a phase III study for evinacumab. We again remind investors that in Mar 2017, another company, Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) and its partner The Medicines Company have 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. Earlier in Jan 2017, Medicines Company had announced the initiation of ORION-2 for evaluating the efficacy, safety and tolerability of Inclisiran in patients with HoFH.

Zacks Rank & Key Picks

Regeneron currently carries a Zacks Rank #2 (Buy). A favorably placed stock in healthcare sector is VIVUS, Inc. which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’s loss per share estimates narrowed down from 50 cents to 39 cents for 2017 in the last 30 days. The company posted positive earnings surprises in all four trailing quarters with an average beat of 233.69%.

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