Intercept Pharma Disappoints on FDA Extension

Intercept Pharmaceuticals Inc. (NASDAQ: ICPT) lagged the markets on Friday morning as the result of an extension by the U.S. Food and Drug Administration (FDA). The company announced that the 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).

As a response to an information request from the FDA, additional clinical data analyses have been submitted. And in order 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.

Separately, the FDA has also notified Intercept of a planned advisory committee meeting date of April 7, 2016.

For some background: OCA is being developed for a variety of chronic liver diseases, including PBC, nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia.

Ultimately, 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.
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Previously, the FDA has granted OCA breakthrough therapy designation for the treatment of NASH with liver fibrosis and granted OCA fast track designation for the treatment of patients with PBC. OCA has also received orphan drug designation in both the United States and Europe for the treatment of PBC and PSC.

Shares of Intercept closed Thursday down 4.8% at $165.95, with a consensus analyst price target of $358.00 and a 52-week trading range of $137.28 to $314.88. Early Friday, shares were trading down 6.3% at $155.51.