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News Breaks
April 12, 2014
20:04 EDTICPTIntercept reports additional positive data from POISE trial at EASL
Intercept Pharmaceuticals announced efficacy and safety results from the Phase 3 POISE trial of obeticholic acid, OCA, for the treatment of primary biliary cirrhosis, PBC, to be presented in a late-breaker session at the International Liver Congress of the European Association for the Study of the Liver, EASL. OCA, Intercept's lead product candidate, is a bile acid analog and first-in-class agonist of the farnesoid X receptor, FXR in development for PBC, nonalcoholic steatohepatitis, NASH, and other liver and intestinal diseases. As previously reported, the POISE trial met its primary endpoint with high statistical significance, demonstrating OCA's efficacy on a composite liver biochemical endpoint which has been shown to strongly correlate with improved clinical outcomes. 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. New data in the presentation show that OCA treated patients achieved a highly statistically significant reduction in alkaline phosphatase, ALP, as early as two weeks, with a peak effect achieved by six months.Pruritus, generally mild to moderate, was the most frequently reported adverse event in the POISE trial. However, only 1% of the patients in the OCA 5-10 mg titration group discontinued therapy due to pruritus after moving up to the 10 mg dose, as compared to seven, 10%, of the patients in the 10 mg OCA group. Additional data presented show that the incidence and severity of OCA related pruritus diminishes with time on therapy. Specifically, pruritus scores were no different from placebo in both OCA treatment groups during the second half of the trial.
News For ICPT From The Last 14 Days
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May 21, 2015
10:58 EDTICPTDeutsche Bank biotech analyst holds an analyst/industry conference call
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09:58 EDTICPTOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Alibaba (BABA) initiated with an Outperform at Bernstein... Alkermes (ALKS) initiated with an Overweight at Barclays... Burlington Stores (BURL) initiated with an Outperform at FBR Capital... Crocs (CROX) initiated with a Neutral at B. Riley... Darling (DAR) initiated with a Buy at Roth Capital... Dynegy (DYN) initiated with an Outperform at RBC Capital... Esperion (ESPR) initiated with an Overweight at Barclays... Five Below (FIVE) initiated with a Market Perform at FBR Capital... Intercept (ICPT) initiated with an Overweight, $450 target at Barclays... Johnson Matthey (JMPLY) initiated with a Buy at Jefferies... Nike (NKE) initiated with a Buy at Jefferies... RTI Surgical (RTIX) initiated with a Buy at Sidoti... TeleNav (TNAV) initiated with an Outperform at Northland... Trevena (TRVN) initiated with an Equal Weight at Barclays... Vectrus (VEC) initiated with a Hold at Stifel.
05:41 EDTICPTIntercept initiated with an Overweight, $450 target at Barclays
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05:37 EDTICPTAlkermes initiated with an Overweight at Barclays
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May 20, 2015
07:05 EDTICPTIntercept update in-line with expectations, says Baird
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May 19, 2015
16:23 EDTICPTOn The Fly: Top stock stories for Tuesday
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11:57 EDTICPTFollow-up: Intercept downgraded on lack of catalysts at BofA/Merrill
As previously reported, BofA/Merrill downgraded Intercept to Neutral from Buy. The firm said with the announcement of Intercept's Phase 3 REGENERATE trial to evaluate OCA for NASH removes a catalyst for shares. BofA/Merrill believes the focus will now turn to PBC approval and expected in 1H 2016 launch, which is reflected in valuation. The firm maintains its $315 price target.
11:46 EDTICPTIntercept downgraded to Neutral from Buy at BofA/Merrill
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11:09 EDTICPTIntercept trial endpoints not surprising, says Deutsche Bank
Deutsche Bank says it is not surprised by the design or size of the Phase 3 OCA trial announced this morning. The firm has a Buy rating on Intercept with a $500 price target.
10:07 EDTICPTIntercept shares defended on trial design at Cowen
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09:52 EDTICPTIntercept weakness a buying opportunity, says RBC Capital
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06:32 EDTICPTIntercept to host conference call
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06:08 EDTICPTIntercept announces international Phase 3 trial of OCA
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May 11, 2015
06:10 EDTICPTIntercept reports Q1 EPS ($1.78), consensus ($1.69)
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