REGNRegeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sarilumab, an investigational interleukin-6 receptor (IL-6R) antibody for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

The CRL refers to certain deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished, one of the last steps in the manufacturing process.  Satisfactory resolution of these deficiencies is required before the BLA can be approved.  Sanofi submitted a comprehensive corrective action plan to the FDA and is implementing the corrective actions specified in that plan. Sanofi is working closely with the FDA towards a timely resolution that addresses these concerns. The CRL does not identify any concerns relating to the safety or efficacy of sarilumab. (Original Source)

Shares of Regeneron are currently trading at $356.27, down $9.08 or -2.49%. 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 $395.05 and its 200-day moving average is $391.37.

On the ratings front, Regeneron has been the subject of a number of recent research reports. In a report released today, Roth Capital analyst Joseph Pantginis reiterated a Buy rating on REGN, with a price target of $520, which represents a potential upside of 43% from where the stock is currently trading. Separately, on October 25, Leerink Swann’s Geoff Porges reiterated a Buy rating on the stock and has a price target of $513.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Geoff Porges have a yearly average loss of 13.3% and 6.1% respectively. Pantginis has a success rate of 31% and is ranked #4041 out of 4188 analysts, while Porges has a success rate of 18% and is ranked #3791.

Sentiment in the Street is mostly Neutral on REGN stock. Out of 15 analysts who cover the stock, 9 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 $487.67, which implies an upside of 34% from current levels.

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.