Company Update (NASDAQ:ICPT): FDA Extends PDUFA Date for Intercept Pharmaceuticals Inc’s Obeticholic Acid for the Treatment of PBC

Intercept Pharmaceuticals Inc (NASDAQ:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic, underserved liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its Priority Review of obeticholic acid (OCA) in primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC). In response to an information request from the FDA, additional clinical data analyses have been submitted. To provide time for a full review of the submission, the original PDUFA date of February 29, 2016 has been extended by three months, resulting in a new PDUFA date of May 29, 2016. The FDA has also notified Intercept of a planned advisory committee meeting date of April 7, 2016.

Intercept is seeking approval of OCA for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. (Original Source)

Shares of Intercept Pharmaceuticals are down 6.28% to $155.52 in early trading. ICPT has a 1-year high of $314.88 and a 1-year low of $129.30. The stock’s 50-day moving average is $170.52 and its 200-day moving average is $206.33.

On the ratings front, Intercept has been the subject of a number of recent research reports. In a report issued on December 2, UBS analyst Matt Roden maintained a Buy rating on ICPT, with a price target of $465, which implies an upside of 180.2% from current levels. Separately, on the same day, Needham’s Alan Carr maintained a Buy rating on the stock .

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Matt Roden and Alan Carr have a total average return of 24.7% and 25.0% respectively. Roden has a success rate of 76.8% and is ranked #71 out of 3645 analysts, while Carr has a success rate of 58.2% and is ranked #19.

The street is mostly Bullish on ICPT stock. Out of 10 analysts who cover the stock, 6 suggest a Buy rating, 2 suggest a Sell and 2 recommend to Hold the stock. The 12-month average price target assigned to the stock is $321.50, which implies an upside of 93.7% from current levels.

Intercept Pharmaceuticals Inc is a biopharmaceutical company. The Company is engaged in the development and commercialization of novel therapeutics to treat chronic liver disease utilizing its proprietary bile acid chemistry.


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