Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi announced that the companies have completed enrollment in the global Phase 3 ODYSSEY OUTCOMES trial, which is prospectively evaluating the potential cardiovascular (CV) benefits of Praluent® (alirocumab) Injection after an acute coronary syndrome (ACS). The 18,000-patient OUTCOMES trial is expected to be completed in 2017.
ODYSSEY OUTCOMES is designed to determine whether the addition of Praluent to intensive statin therapy reduces major adverse cardiac events among patients who had previously experienced an ACS, such as a heart attack or unstable angina. The primary endpoint evaluates the time to first occurrence of coronary heart disease death, acute myocardial infarction, hospitalization for unstable angina, or fatal and non-fatal ischemic stroke. Patients with recent ACS were selected as the study population because they face a higher risk of recurrent events than patients with stable cardiovascular disease.
Praluent is currently approved in the U.S. and EU to reduce bad (LDL) cholesterol in some patients with significant unmet need, including those with established cardiovascular disease, or an inherited form of high cholesterol, called heterozygous familial hypercholesterolemia (HeFH). The effect of Praluent on CV morbidity and mortality has not yet been determined.
The global ODYSSEY program includes 16 Phase 3 trials conducted at more than 2,000 study centers, around the world, and once complete will evaluate more than 25,000 patients. Data from this program helped form one of the most comprehensive data sets ever used for the initial regulatory filing of a cholesterol-lowering therapy. In completed trials, Praluent reduced LDL cholesterol by up to an additional 62 percent versus placebo, and was generally well-tolerated with an acceptable safety profile.
The ODYSSEY OUTCOMES trial design was published in the American Heart Journal in November 2014. (Original Source)
Shares of Regeneron closed yesterday at $570.85, down $8.70 or -1.5%. REGN has a 1-year high of $605.93 and a 1-year low of $383.87. The stock’s 50-day moving average is $541.65 and its 200-day moving average is $529.77.
On the ratings front, Regeneron has been the subject of a number of recent research reports. In a report issued on November 12, Roth Capital analyst Joseph Pantginis reiterated a Hold rating on REGN, with a price target of $543, which represents a slight downside potential from current levels. Separately, on November 5, J.P. Morgan’s Cory Kasimov reiterated a Hold rating on the stock and has a price target of $578.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Cory Kasimov have a total average return of -3.5% and -1.4% respectively. Pantginis has a success rate of 36.6% and is ranked #3478 out of 3636 analysts, while Kasimov has a success rate of 48.3% and is ranked #2941.
The street is mostly Neutral on REGN stock. Out of 9 analysts who cover the stock, 6 suggest a Hold rating and 3 recommend to Buy the stock. The 12-month average price target assigned to the stock is $594.83, which represents a slight upside potential from current levels.
Regeneron Pharmaceuticals Inc is a fully integrated biopharmaceutical company. It discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.