Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi SA (ADR) (NYSE:SNY) announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for dupilumab for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD), a serious, chronic inflammatory skin disease. The application has been given a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2017. The investigational antibody therapy dupilumab 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 BLA for dupilumab contains data from three Phase 3 pivotal studies in the global LIBERTY AD program that included more than 2,500 patients. The goal of the studies was to evaluate dupilumab 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. In 2014, theFDA granted Breakthrough Therapy designation to dupilumab for the treatment of adults with moderate-to-severe AD who are not adequately controlled with topical prescription therapies or for whom these treatments are not appropriate.
Dupilumab is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority. If approved, dupilumab would be commercialized by Regeneron and Sanofi Genzyme, the specialty care global business of Sanofi. (Original Source)
Shares of Regeneron are currently trading at $404.36, down $6.03 or -1.47%. REGN has a 1-year high of $592.59 and a 1-year low of $329.09. The stock’s 50-day moving average is $405.79 and its 200-day moving average is $389.84.
On the ratings front, Regeneron has been the subject of a number of recent research reports. In a report issued on September 23, Wells Fargo analyst Jim Birchenough reiterated a Hold rating on REGN. Separately, on September 21, Baird’s Brian Skorney reiterated a Hold rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jim Birchenough and Brian Skorney have a total average return of 22.4% and 20.1% respectively. Birchenough has a success rate of 54% and is ranked #72 out of 4183 analysts, while Skorney has a success rate of 60% and is ranked #77.
Overall, 9 research analysts have assigned a Hold rating and 6 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $480.20 which is 17.0% above where the stock closed last Friday.
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. Regeneron Pharmaceuticals was founded by Alferd G. Gilman, Leonard S.