Stock Update (NASDAQ:REGN): Regeneron Pharmaceuticals Inc and Sanofi Announce Marketing Authorization Application for Dupixent Accepted for Review by the EMA


REGNRegeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for Dupixent® (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. The investigational biologic therapy Dupixent inhibits signaling of IL-4 and IL-13, two key cytokines required for the type 2 (including Th2) immune response, which is believed to be a major driver in the pathogenesis of the disease.

The MAA for Dupixent contains data from three Phase 3 pivotal studies in the global LIBERTY AD program that included more than 2,500 patients. The objective of the studies was to evaluate Dupixent as monotherapy (SOLO 1 and SOLO 2) and in concomitant administration with topical corticosteroids (CHRONOS) in adult patients with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies.

A biologics license application (BLA) for Dupixent was accepted for Priority Review by the U.S. Food and Drug Administration (FDA) in September 2016. Per the Prescription Drug User Fee Act (PDUFA), the target FDA action date is March 29, 2017. The European Medicines Agency (EMA) and FDA have conditionally accepted Dupixent as the trade name for dupilumab.

Dupixent is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority. In addition to AD in adults, Dupixent is being studied in pediatric AD, asthma, nasal polyposis and eosinophilic esophagitis. If approved, Dupixent would be commercialized by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi. (Original Source)

Shares of Regeneron are currently trading flat $362.04. REGN has a 1-year high of $563.79 and a 1-year low of $325.35. The stock’s 50-day moving average is $368.36 and its 200-day moving average is $391.56.

On the ratings front, REGN stock has been the subject of a number of recent research reports. In a report issued on December 5, RBC analyst Adnan Butt assigned a Buy rating on REGN, with a price target of $626, which represents a potential upside of 73% from where the stock is currently trading. Separately, on December 1, Leerink Swann’s Geoff Porges reiterated a Buy rating on the stock and has a price target of $500.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Adnan Butt and Geoff Porges have a yearly average loss of 3.7% and 6.1% respectively. Butt has a success rate of 41% and is ranked #3749 out of 4271 analysts, while Porges has a success rate of 14% and is ranked #3986.

Sentiment on the street is mostly neutral on REGN stock. Out of 16 analysts who cover the stock, 10 suggest a Hold rating , 5 suggest a Buy and one recommends to Sell the stock. The 12-month average price target assigned to the stock is $431.67, which represents a potential upside of 19% from where the stock is currently trading.

Regeneron Pharmaceuticals, Inc. operates as a biopharmaceutical company. It discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. The company involves in marketing medicines for eye diseases, colorectal cancer and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, asthma and atopic dermatitis. Its products include EYLEA (aflibercept) injection, which is used for the treatment of neovascular age related macular degeneration; ARCALYST (rilonacept), which is used for the treatment of Cryopyrin-Associated Periodic Syndrome, including Familial Cold Auto-inflammatory Syndrome and Muckle-Wells Syndrome; and PRALUENT (alirocumab) Injection for treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL- C.