FDA Extends PDUFA Date for Obeticholic Acid for the Treatment of PBC

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Consensus Needs to Come Down on Intercept (ICPT) after FDA Review is Extended - Leerink

December 18, 2015 8:44 AM EST

Leerink Partners analyst, Joseph Schwartz noted that Intercept Pharmaceuticals (NASDAQ: ICPT) announced that the FDA has extended the PDUFA date for its priority review application of Obeticholic acid (OCA) in primary biliary cirrhosis/ cholangitis (PBC) by 3 mos. to May 29, 2016. ICPT stated that FDA had requested additional information, to which ICPT has... More

FDA Pushed Back Intercept Pharma's (ICPT) PDUFA Date; Seeks More Data - Baird Maintains Outperform

December 18, 2015 7:41 AM EST

Baird maintained an Outperform rating and $346.00 price target on Intercept Pharmaceuticals (NASDAQ: ICPT) following the company's announcement that the FDA pushed out its Prescription Drug User Fee Act (PDUFA) date for the priority review of obeticholic acid (OCA) in primary biliary cholangitis (PBC). The... More