Intercept Pharmaceutical's Shares Soar On Earnings
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.
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