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News Breaks
March 16, 2014
14:37 EDTICPTIntercept Phase 3 POISE trial of OCA meets primary endpoint
Intercept Pharmaceuticals announced that its international Phase 3 POISE trial of obeticholic acid. OCA, for the treatment of primary biliary cirrhosis, PBC, demonstrated that OCA, at both a 10 mg dose and a 5 mg dose titrated to 10 mg, met the trial's primary endpoint of achieving a reduction in serum alkaline phosphatase to < 1.67x ULN with a = 15% reduction from baseline and a normal bilirubin level after 12 months of therapy. The proportion of patients meeting the POISE primary endpoint was: 10% in the placebo group, 47% in the 10 mg OCA group and 46% in the 5-10 mg OCA group in an intention to treat analysis. In addition, both OCA dose groups met pre-specified secondary endpoints of improvements in other liver function parameters, including GGT, ALT, AST and total bilirubin. In order to evaluate the clinical relevance of the POISE primary endpoint, Intercept sponsored an independent study conducted by the Global PBC Study Group, consisting of 15 leading PBC centers in eight countries that contributed to a clinical outcomes database of more than 6,000 PBC patients. In this study, patients who did not achieve the POISE endpoint after one year were shown to have a greatly increased risk of liver transplant or death compared to those who achieved the endpoint. The PBC Supergroup has also previously confirmed that higher ALP levels in patients correlate with increased risk of liver transplant and death.
News For ICPT From The Last 14 Days
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August 28, 2014
17:05 EDTICPTOrbiMed reports 7% stake in Intercept
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August 26, 2014
07:46 EDTICPTIntercept Pharmaceuticals volatility at low end of historic range
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August 18, 2014
10:57 EDTICPTOptions with decreasing implied volatility
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August 15, 2014
17:02 EDTICPTStocks end week slightly higher despite flare-up in Russian tensions
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10:41 EDTICPTOptions with decreasing implied volatility
Options with decreasing implied volatility: ARWR ICPT UVXY MNKD KING VIX SVXY VXX RAX OPK
10:01 EDTICPTOn The Fly: Analyst Initiation Summary
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06:32 EDTICPTIntercept started with Underperform, $172 target at FBR Capital
FBR Capital initiated shares of Intercept with an Underperform rating and $172 price target. The stock closed yesterday at $296.36. FBR believes investors are too optimistic on the nonalcoholic steatohepatitis market and the company's path to commercialization for its obeticholic acid. The firm thinks Intercept may face payor pushback and restriction as its drug will be competing with hepatitis C treatments for dollars.
06:16 EDTICPTIntercept initiated with an Underperform at FBR Capital
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