In a research report sent to investors today, Roth Capital analyst Joseph Pantginis reiterated a Buy rating on Regeneron Pharmaceuticals (NASDAQ:REGN) with a price target of $461 price target, following the news that the FDA accepted the company’s Praluent (alirocumab) BLA for Priority Review with a target action date of July 24, 2015.
Pantginis noted, “With filings in both the U.S. and EU, this is the last stretch for REGN and partner Sanofi (NYSE:SNY) following their extensive development programs, most prominently visible through their Phase III ODYSSEY program. Recall that 10 Phase III ODYSSEY studies have achieved their primary and secondary endpoints, successfully lowering LDL-C in various short and long-term time frames measured in several dosing regimens, including a monthly schedule.”
The analyst continued, “The application package submitted to FDA and EMA contains data from over 5,000 patients. With an expanding target population, estimated to have 36 million eligible patients in the U.S. and EU by 2016, we believe both REGN and AMGN have a sizable “playing field” to fulfill their drug’s potential. Both alirocumab and evolocumab have shown significant efficacy in reducing LDLC levels in hypercholesterolemia patients, including in populations who do not respond adequately or are intolerant to statin therapy as well as in high CV risk populations.”
Regeneron Pharmaceuticals, Inc., a biopharmaceutical company, discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions in the United States and internationally.