Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sarilumab. Per the Prescription Drug User Fee Act (PDUFA), the target action date is October 30, 2016. Sarilumab is an investigational, human monoclonal antibody directed against the IL-6 receptor that is intended for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA). IL-6 is the most abundant cytokine in the serum and synovial fluid of patients with RA and levels correlate with both disease activity and joint destruction.
The BLA for sarilumab contains data from approximately 2,500 adults with active, moderate-to-severe RA who had an inadequate response to previous treatment regimens, including seven studies from the global SARIL-RA Phase 3 program.
The goal of the ongoing global clinical development program is to evaluate the safety and efficacy of subcutaneous sarilumab, either as monotherapy or in combination with conventional disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate (MTX), in reducing the signs and symptoms and inhibiting the radiographic progression of RA.
The safety and efficacy of sarilumab have not been fully evaluated by any regulatory authority. (Original Source)
Shares of Regeneron Pharmaceuticals closed yesterday at $501.96, down $17.52 or -3.37%. REGN has a 1-year high of $605.93 and a 1-year low of $393. The stock’s 50-day moving average is $545.55 and its 200-day moving average is $537.45.
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 implies an upside of 8.2% 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 -7.3% and -5.6% respectively. Pantginis has a success rate of 34.6% and is ranked #3586 out of 3630 analysts, while Kasimov has a success rate of 37.4% and is ranked #3440.
The street is mostly Neutral on REGN stock. Out of 5 analysts who cover the stock, 3 suggest a Hold rating and 2 recommend to Buy the stock. The 12-month average price target assigned to the stock is $619.50, which represents a potential upside of 23.4% from where the stock is currently trading.
Regeneron Pharmaceuticals Inc is a fully integrated biopharmaceutical company. It discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.