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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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January 30, 2015
12:45 EDTICPTOn The Fly: Midday Wrap
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09:26 EDTICPTOn The Fly: Pre-market Movers
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08:27 EDTICPTIntercept breakthrough designation a significant positive, says Summer Street
Summer Street views the breakthrough therapy designation from the FDA as a significant positive for Intercept. The firm believes the news supports its thesis that Intercept's OCA is potentially a "game changer" in the treatment of NASH. It keeps a Buy rating on the stock with a $650 price target.
January 29, 2015
19:14 EDTICPTOn The Fly: After Hours Movers
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16:31 EDTICPTIntercept gets breakthrough designation from FDA for steatohepatitis treatment
Intercept Pharmaceuticals announced that its investigational product obeticholic acid, or OCA, has received "breakthrough therapy designation" from the FDA for the treatment of patients with nonalcoholic steatohepatitis, or NASH, with liver fibrosis. This indication constitutes a population of patients with a serious and life-threatening condition reflected by a higher risk of progression to cirrhosis and liver failure. OCA is currently being developed for the treatment of several chronic liver diseases, including primary biliary cirrhosis, NASH and primary sclerosing cholangitis.
January 22, 2015
07:17 EDTICPTIntercept price target lowered to $300 from $500 at Deutsche Bank
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