Shares of Regeneron Pharmaceuticals, Inc. REGN have been riding high after the company announced that 18-month data from a phase III study on its PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody, Praluent, were published online in The New England Journal of Medicine..
Shares of the company hit a 52-week high of $468.50 on Mar 17, eventually closing a little lower at $467.80. So far, the stock has gained 10.6% on the news.
The Positive Praluent Data
The phase III ODYSSEY LONG TERM study compared the use of Praluent 150 mg every two weeks to placebo in patients who were at high cardiovascular (CV) risk and who were receiving maximally-tolerated statin therapy with or without other lipid lowering treatment. The study also included patients with heterozygous familial hypercholesterolemia.
At week 78, a 56% reduction from baseline in low-density lipoprotein-cholesterol was observed in patients receiving Praluent as compared to placebo. The efficacy of Praluent remained consistent throughout treatment. At week 78, positively adjudicated pre-specified CV adverse events occurred in 4.6% of patients on Praluent and 5.1% of patients on placebo. Fewer major cardiovascular events (including coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) were observed with Praluent in a post hoc analysis.
Regeneron is collaborating with Sanofi SNY for the candidate. The companies are looking to get the candidate approved for the treatment of patients suffering from hypercholesterolemia. We remind investors that Regeneron and Sanofi had announced that the regulatory application for Praluent was accepted for priority review by the FDA. The FDA is expected to render a final decision by Jul 24, 2015. Meanwhile, the European Medicines Agency has also accepted the marketing authorization application for Praluent.
We believe that Praluent has a huge market potential. We remind investors that Amgen AMGN is also seeking FDA approval for its PCSK9 inhibitor, Repatha. Repatha is currently under review both in the U.S. and EU.
Regeneron carries a Zacks Rank #4 (Sell). Acorda Therapeutics, Inc. ACOR is a better-ranked stock in the health care sector sporting a Zacks Rank #1 (Strong Buy).
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