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Intercept Pharmaceutical's Shares Soar On Earnings

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Shares of Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT) are up more than 40 percent in Monday's post market session, following the release of the company's 2014 second quarter earnings report and business update.

Intercept provided the following highlights on its key development programs.


NASH Program

  • FLINT trial data provided in 10-Q filing and to be discussed on today's conference call
  • Phase 3 program initiation anticipated in 1H 2015, pending regulatory feedback
  • Phase 2 lipid metabolism trial initiation anticipated in 1H 2015

 

PBC Program

  • Fast Track designation granted by FDA
  • Phase 3 confirmatory trial protocol finalization anticipated in 3Q 2014 and initiation planned around year-end 2014
  • Pre-NDA and pre-MAA meetings anticipated in 4Q 2014 with completed filings anticipated in 1H 2015

 

Primary Sclerosing Cholangitis (PSC) Program

  • Double-blind phase 2 trial initiation anticipated year-end 2014
  • First clinical trial of OCA in this orphan indication with high unmet medical need

 

INT-767 Phase 1 Trial Initiation Anticipated in 1H 2015

Intercept is scheduled to hold its second quarter conference call at 4:30 pm ET and can be accessed on the company's IR page.

Posted-In: Earnings News

 

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