Monday 6-9-2014 Intercept Pharmaceuticals Inc (ICPT) $ICPT opened at 268.56 hitting the high price of 297.67 and a day low of 268.32 with a total volume of 889,933. ICPT had a previous close of 267.97 and has been seeing an average volume of 589,882.
Overall Average: 32% Buy
Recent stock forum discussions about ICPT http://investorshangout.com/search?q=ICPT&...mp;yt0=Go!
Intercept to Present at Upcoming Investor Conferences
GlobeNewswire - Fri Jun 06, 7:05AM CDT
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel bile acid therapeutics to treat chronic liver and intestinal diseases, today announced management will be participating in the following upcoming investor conferences: (full story)
Nasdaq stocks posting largest percentage increases
AP - Thu Jun 05, 5:02PM CDT
NEW YORK (AP) — A look at the 10 biggest percentage gainers on Nasdaq at the close of trading: (full story)
FDA Approvals, Digital Health Guidance, Conference Presentations, and Recognitions - Analyst Notes on Intercept Pharmaceuticals, Cigna, Baxter, Questcor and Mallinckrodt
PR Newswire - Tue Jun 03, 6:00AM CDT
Today, Analysts Review released its analysts' notes regarding Intercept Pharmaceuticals Inc. (NASDAQ: ICPT), Cigna Corporation (NYSE: CI), Baxter International Inc. (NYSE: BAX), Questcor Pharmaceuticals Inc. (NASDAQ: QCOR) and Mallinckrodt PLC (NYSE: MNK). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/3242-100free. (full story)
Intercept's Obeticholic Acid Gets Fast Track Status - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Thu May 29, 10:50AM CDT
The FDA granted Fast Track status to OCA for treating PBC patients. (full story)
Primary Sclerosing Cholangitis Therapeutics Pipeline Review 2014
M2 - Thu May 29, 10:14AM CDT
Research and Markets (http://www.researchandmarkets.com/research/3zmvm9/primary) has announced the addition of the "Primary Sclerosing Cholangitis - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Primary Sclerosing Cholangitis, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Primary Sclerosing Cholangitis and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Companies Involved in Therapeutics Development - Gilead Sciences, Inc. - Intercept Pharmaceuticals, Inc. - Dr. Falk Pharma GmbH - Lumena Pharmaceuticals, Inc. Scope - The report provides a snapshot of the global therapeutic landscape of Primary Sclerosing Cholangitis - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Primary Sclerosing Cholangitis and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Primary Sclerosing Cholangitis products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages - A detailed assessment of monotherapy and combination therapy pipeline projects - Coverage of the Primary Sclerosing Cholangitis pipeline on the basis of target, MoA, route of administration and molecule type - Latest news and deals relating related to pipeline products For more information visit http://www.researchandmarkets.com/research/3zmvm9/primary (full story)
Alcoholic Hepatitis Therapeutics Pipeline Review 2014
M2 - Thu May 29, 10:08AM CDT
Research and Markets (http://www.researchandmarkets.com/research/m7p2b3/alcoholic) has announced the addition of the "Alcoholic Hepatitis - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Alcoholic Hepatitis, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Alcoholic Hepatitis and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Scope - The report provides a snapshot of the global therapeutic landscape of Alcoholic Hepatitis - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Alcoholic Hepatitis and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Alcoholic Hepatitis products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages - A detailed assessment of monotherapy and combination therapy pipeline projects - Coverage of the Alcoholic Hepatitis pipeline on the basis of target, MoA, route of administration and molecule type - Latest news and deals relating related to pipeline products Companies Involved in Therapeutics Development - Immuron Limited - Conatus Pharmaceuticals Inc. - Intercept Pharmaceuticals, Inc. - Alfact Innovation - Generon (Shanghai) Corporation Ltd. For more information visit http://www.researchandmarkets.com/research/m7p2b3/alcoholic (full story)
Diabetic Retinopathy - Pipeline Review, H1 2014: 29 Companies Profiled
M2 - Thu May 29, 8:57AM CDT
Research and Markets (http://www.researchandmarkets.com/research/pr6rhf/diabetic) has announced the addition of the "Diabetic Retinopathy - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Diabetic Retinopathy, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Diabetic Retinopathy and special features on late-stage and discontinued projects. This report features investigatory drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles/records featured in the report undergoes periodic updates following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis. Scope - The report provides a snapshot of the global therapeutic landscape of Diabetic Retinopathy - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Diabetic Retinopathy and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects Companies Mentioned: - Acucela Inc. - Ampio Pharmaceuticals - Antisense Therapeutics Limited - BioDiem Ltd - Biomar Microbial Technologies - Bionure Farma, S.L. - CCRP Therapeutics GmbH - Charlesson LLC. - EyeCyte - EyeGene - FirstString Research - Foresee Pharmaceuticals, LLC - Gene Signal International SA - Inotek Pharmaceuticals Corporation - Intercept Pharmaceuticals - Lpath - MingSight Pharmaceuticals - Paloma Pharmaceuticals - PanOptica - Promedior - Protagonist Therapeutics Inc. - Protemix Corporation Limited - R-Tech Ueno, Ltd. - RegeneRx Biopharmaceuticals - Resolvyx Pharmaceuticals, Inc - Stelic Institute & Co. - Targazyme - ThromboGenics NV - Vascular Pharmaceuticals For more information visit http://www.researchandmarkets.com/research/pr6rhf/diabetic (full story)
Today's Top Biotech Stocks to Watch: Intercept Pharmaceuticals and VIVUS
George Budwell, The Motley Fool - Motley Fool - Thu May 29, 7:35AM CDT
Let's take a look at today's top stories in biotech and health care. Keep an eye out for Intercept Pharmaceuticals and VIVUS . Intercept could move higher today on positive regulatory news Shares of Intercept Pharmaceuticals climbed over 7%... (full story)
INTERCEPT PHARMA
at Investor's Business Daily - Wed May 28, 5:50PM CDT
INTERCEPT PHARMA (ICPT) received fast-track designation from the FDA for its primary biliary cirrhosis treatment. Shares rose 5.4% to 246.54. (full story)
Intercept Announces that FDA Grants Fast Track Designation to Obeticholic Acid for the Treatment of Patients with Primary Biliary Cirrhosis
GlobeNewswire - Wed May 28, 3:15PM CDT
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a clinical stage biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to obeticholic acid (OCA) for the treatment of patients with primary biliary cirrhosis (PBC). OCA is being developed to treat PBC patients with an inadequate therapeutic response to, or who are unable to tolerate, ursodiol, the only drug currently approved to treat the disease. Intercept intends to complete its New Drug Application (NDA) of OCA for PBC in the first half of 2015. The NDA will include data from the Phase 3 POISE trial and two randomized Phase 2 trials, all of which met their primary endpoints with high statistical significance. (full story)
3 Stocks Crushed by the Market Last Week
Keith Speights, The Motley Fool - Motley Fool - Wed May 28, 8:35AM CDT
Heard a crushing sound lately? It might have come the market's beat-down this week of three particularly unfortunate health-care stocks. One of the week's biggest losers plunged on news of the U.S. Food and Drug Administration's denial of... (full story)
Research and Markets: Intercept Pharmaceuticals' Obeticholic Acid - Clinical/regulatory update
Business Wire - Fri May 23, 6:40PM CDT
Research and Markets (http://www.researchandmarkets.com/research/cw295n/intercept) has announced the addition of the "Intercept Pharmaceuticals' Obeticholic Acid - Clinical/regulatory update" report to their offering. (full story)
Intercept Pharmaceuticals' Obeticholic Acid - Clinical/regulatory update
M2 - Fri May 23, 8:38AM CDT
Research and Markets (http://www.researchandmarkets.com/research/qll444/intercept) has announced the addition of the "Intercept Pharmaceuticals' Obeticholic Acid - Clinical/regulatory update" report to their offering. Obeticholic acid (OCA) is a derivative of chenodeoxycholic acid, the dominant component of bile. It is a potent stimulator of farnesoid X receptor and in that way differs both from chenodeoxycholic acid and ursodeoxycholic acid (URSO), another bile acid used therapeutically. Intercept is developing OCA for use in a variety of liver diseases. Primary biliary cirrhosis (PBC), an orphan inflammatory disease of bile ducts, is the lead indication. But non-alcoholic steatohepatitis (NASH), a liver disorder that substantively overlaps with the epidemiology and pathophysiology of the metabolic syndrome is close behind. Intercept has also initiated/reported pilot efforts in bile acid diarrhea (BAD), acute alcoholic hepatitis, and portal hypertension. This report explores recent developments in these programs in depth, with an eye toward the complex regulatory situation they face. That is, no clear precedents exist and the adverse outcomes one wishes to avoid via therapy are long term. Especially for NASH, the population needing treatment is large and the ability to identify those who will have poor outcomes is difficult. Safety concerns complicate the picture further. Thus, endpoint selection and FDA's acceptance of data showing impact on those measures becomes a central issue when assessing the probabilities of regulatory success. Key Topics Covered: Introduction and background Primary biliary cirrhosis (PBC) - The disease (Medscape.com) - Phase II, including long-term extension data (ICPT 2013 10-K) - POISE (ICPT March 16 release) - Accelerated Approval in PBC and surrogates of transplant-free survival - Will one study be enough? - In summary Non-alcoholic steatohepatitis (NASH) NAFLD and NASHa brief review - Phase II study in diabetic NAFLD - The FLINT study - Endpoint issues and approval pathways for NASH - In summary - Update on lipid changes in phase II studies of fatty liver - Update on other indications Summary opinion - PBC - NASH - Other indications - In conclusion For more information visit http://www.researchandmarkets.com/research/qll444/intercept (full story)
Research and Markets: Intercept Pharmaceuticals' Obeticholic Acid for Liver Diseases Report
Business Wire - Fri May 23, 3:01AM CDT
Research and Markets (http://www.researchandmarkets.com/research/rh9xhp/intercept) has announced the addition of the "Intercept Pharmaceuticals' Obeticholic Acid for Liver Diseases" report to their offering. (full story)
Intercept Pharmaceuticals' Obeticholic Acid for Liver Diseases Report
M2 - Fri May 23, 2:03AM CDT
Research and Markets (http://www.researchandmarkets.com/research/bfcxg8/intercept) has announced the addition of the "Intercept Pharmaceuticals' Obeticholic Acid for liver diseases" report to their offering. Obeticholic acid (OCA) is a derivative of chenodeoxycholic acid, the dominant component of bile. It is a potent stimulator of farnesoid X receptor and in that way differs both from chenodeoxycholic acid and ursodeoxycholic acid (URSO), another bile acid used therapeutically. Intercept is developing OCA for use in a variety of liver diseases. Primary biliary cirrhosis (PBC), an orphan inflammatory disease of bile ducts, is the lead indication. But non-alcoholic steatohepatitis (NASH), a liver disorder that substantively overlaps with the epidemiology and pathophysiology of the metabolic syndrome is close behind. Intercept has also initiated/reported pilot efforts in bile acid diarrhea (BAD), acute alcoholic hepatitis, and portal hypertension. This initiation report explores these programs in depth, including the underlying rationale for use and a review of the phase II data in the lead PBC and NASH indications. It also explores issues related to the later phase trials for those indications, including the selection of endpoints. In PBC and especially in NASH, the ability to identify those who will have poor long-term outcomes (and thus would benefit from therapy) is difficult. Thus, endpoint selection and FDA's acceptance of data showing impact on those measures becomes a central issue when assessing the probabilities of regulatory success. The report also reviews the rationale and available data from the other programs and also looks at the competitive landscapes for each. Key Topics Covered: 1. Primary biliary cirrhosis (PBC) - The disease - Phase II, including long-term extension data (ICPT 2013 10-K) - POISE - Accelerated Approval in PBC and surrogates of transplant-free survival - Will one study be enough? - In summary 2. Non-alcoholic steatohepatitis (NASH) - NAFLD and NASHa brief review - Phase II study in diabetic NAFLD - The FLINT study - Endpoint issues and approval pathways for NASH - Update on lipid changes in phase II studies of fatty liver 3. Update on other indications 4. Summary opinion - PBC - NASH - Other indications Companies Mentioned - Albireo - Antipodean Pharmaceuticals - Intercept Pharmaceuticals - Johnson & Johnson - Kotobuki Pharmaceuticals - NovImmune - Phenex For more information visit http://www.researchandmarkets.com/research/bfcxg8/intercept About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. (full story)
Intercept Sinks on Cholesterol Issue - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Wed May 21, 4:12PM CDT
Intercept Pharmaceuticals (ICPT) shares tumbled 14.1% after a report from The Street disclosed that the company had information about the occurrence of abnormal cholesterol levels in its phase IIb study on obeticholic acid. (full story)
Today's Dead Cat Bounce Stock Is Intercept Pharmaceuticals (ICPT)
at The Street - Wed May 21, 8:52AM CDT
Trade-Ideas LLC identified Intercept Pharmaceuticals (ICPT) as a "dead cat bounce" (down big yesterday but up big today) candidate (full story)
Intercept Pharma, Government Scientists Spar Over Negative Safety of Liver Drug, Emails Show
at The Street - Tue May 20, 5:00AM CDT
Intercept Pharmaceuticals knew last January that abnormal cholesterol levels in patients contributed to the early stopping of a clinical trial involving its liver disease drug obeticholic acid, or OCA, but the company chose not to tell investors and... (full story)
Overall Average: 32% Buy
Recent stock forum discussions about ICPT http://investorshangout.com/search?q=ICPT&...mp;yt0=Go!
Intercept to Present at Upcoming Investor Conferences
GlobeNewswire - Fri Jun 06, 7:05AM CDT
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel bile acid therapeutics to treat chronic liver and intestinal diseases, today announced management will be participating in the following upcoming investor conferences: (full story)
Nasdaq stocks posting largest percentage increases
AP - Thu Jun 05, 5:02PM CDT
NEW YORK (AP) — A look at the 10 biggest percentage gainers on Nasdaq at the close of trading: (full story)
FDA Approvals, Digital Health Guidance, Conference Presentations, and Recognitions - Analyst Notes on Intercept Pharmaceuticals, Cigna, Baxter, Questcor and Mallinckrodt
PR Newswire - Tue Jun 03, 6:00AM CDT
Today, Analysts Review released its analysts' notes regarding Intercept Pharmaceuticals Inc. (NASDAQ: ICPT), Cigna Corporation (NYSE: CI), Baxter International Inc. (NYSE: BAX), Questcor Pharmaceuticals Inc. (NASDAQ: QCOR) and Mallinckrodt PLC (NYSE: MNK). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/3242-100free. (full story)
Intercept's Obeticholic Acid Gets Fast Track Status - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Thu May 29, 10:50AM CDT
The FDA granted Fast Track status to OCA for treating PBC patients. (full story)
Primary Sclerosing Cholangitis Therapeutics Pipeline Review 2014
M2 - Thu May 29, 10:14AM CDT
Research and Markets (http://www.researchandmarkets.com/research/3zmvm9/primary) has announced the addition of the "Primary Sclerosing Cholangitis - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Primary Sclerosing Cholangitis, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Primary Sclerosing Cholangitis and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Companies Involved in Therapeutics Development - Gilead Sciences, Inc. - Intercept Pharmaceuticals, Inc. - Dr. Falk Pharma GmbH - Lumena Pharmaceuticals, Inc. Scope - The report provides a snapshot of the global therapeutic landscape of Primary Sclerosing Cholangitis - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Primary Sclerosing Cholangitis and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Primary Sclerosing Cholangitis products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages - A detailed assessment of monotherapy and combination therapy pipeline projects - Coverage of the Primary Sclerosing Cholangitis pipeline on the basis of target, MoA, route of administration and molecule type - Latest news and deals relating related to pipeline products For more information visit http://www.researchandmarkets.com/research/3zmvm9/primary (full story)
Alcoholic Hepatitis Therapeutics Pipeline Review 2014
M2 - Thu May 29, 10:08AM CDT
Research and Markets (http://www.researchandmarkets.com/research/m7p2b3/alcoholic) has announced the addition of the "Alcoholic Hepatitis - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Alcoholic Hepatitis, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Alcoholic Hepatitis and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Scope - The report provides a snapshot of the global therapeutic landscape of Alcoholic Hepatitis - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Alcoholic Hepatitis and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Alcoholic Hepatitis products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages - A detailed assessment of monotherapy and combination therapy pipeline projects - Coverage of the Alcoholic Hepatitis pipeline on the basis of target, MoA, route of administration and molecule type - Latest news and deals relating related to pipeline products Companies Involved in Therapeutics Development - Immuron Limited - Conatus Pharmaceuticals Inc. - Intercept Pharmaceuticals, Inc. - Alfact Innovation - Generon (Shanghai) Corporation Ltd. For more information visit http://www.researchandmarkets.com/research/m7p2b3/alcoholic (full story)
Diabetic Retinopathy - Pipeline Review, H1 2014: 29 Companies Profiled
M2 - Thu May 29, 8:57AM CDT
Research and Markets (http://www.researchandmarkets.com/research/pr6rhf/diabetic) has announced the addition of the "Diabetic Retinopathy - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Diabetic Retinopathy, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Diabetic Retinopathy and special features on late-stage and discontinued projects. This report features investigatory drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles/records featured in the report undergoes periodic updates following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis. Scope - The report provides a snapshot of the global therapeutic landscape of Diabetic Retinopathy - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Diabetic Retinopathy and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects Companies Mentioned: - Acucela Inc. - Ampio Pharmaceuticals - Antisense Therapeutics Limited - BioDiem Ltd - Biomar Microbial Technologies - Bionure Farma, S.L. - CCRP Therapeutics GmbH - Charlesson LLC. - EyeCyte - EyeGene - FirstString Research - Foresee Pharmaceuticals, LLC - Gene Signal International SA - Inotek Pharmaceuticals Corporation - Intercept Pharmaceuticals - Lpath - MingSight Pharmaceuticals - Paloma Pharmaceuticals - PanOptica - Promedior - Protagonist Therapeutics Inc. - Protemix Corporation Limited - R-Tech Ueno, Ltd. - RegeneRx Biopharmaceuticals - Resolvyx Pharmaceuticals, Inc - Stelic Institute & Co. - Targazyme - ThromboGenics NV - Vascular Pharmaceuticals For more information visit http://www.researchandmarkets.com/research/pr6rhf/diabetic (full story)
Today's Top Biotech Stocks to Watch: Intercept Pharmaceuticals and VIVUS
George Budwell, The Motley Fool - Motley Fool - Thu May 29, 7:35AM CDT
Let's take a look at today's top stories in biotech and health care. Keep an eye out for Intercept Pharmaceuticals and VIVUS . Intercept could move higher today on positive regulatory news Shares of Intercept Pharmaceuticals climbed over 7%... (full story)
INTERCEPT PHARMA
at Investor's Business Daily - Wed May 28, 5:50PM CDT
INTERCEPT PHARMA (ICPT) received fast-track designation from the FDA for its primary biliary cirrhosis treatment. Shares rose 5.4% to 246.54. (full story)
Intercept Announces that FDA Grants Fast Track Designation to Obeticholic Acid for the Treatment of Patients with Primary Biliary Cirrhosis
GlobeNewswire - Wed May 28, 3:15PM CDT
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a clinical stage biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to obeticholic acid (OCA) for the treatment of patients with primary biliary cirrhosis (PBC). OCA is being developed to treat PBC patients with an inadequate therapeutic response to, or who are unable to tolerate, ursodiol, the only drug currently approved to treat the disease. Intercept intends to complete its New Drug Application (NDA) of OCA for PBC in the first half of 2015. The NDA will include data from the Phase 3 POISE trial and two randomized Phase 2 trials, all of which met their primary endpoints with high statistical significance. (full story)
3 Stocks Crushed by the Market Last Week
Keith Speights, The Motley Fool - Motley Fool - Wed May 28, 8:35AM CDT
Heard a crushing sound lately? It might have come the market's beat-down this week of three particularly unfortunate health-care stocks. One of the week's biggest losers plunged on news of the U.S. Food and Drug Administration's denial of... (full story)
Research and Markets: Intercept Pharmaceuticals' Obeticholic Acid - Clinical/regulatory update
Business Wire - Fri May 23, 6:40PM CDT
Research and Markets (http://www.researchandmarkets.com/research/cw295n/intercept) has announced the addition of the "Intercept Pharmaceuticals' Obeticholic Acid - Clinical/regulatory update" report to their offering. (full story)
Intercept Pharmaceuticals' Obeticholic Acid - Clinical/regulatory update
M2 - Fri May 23, 8:38AM CDT
Research and Markets (http://www.researchandmarkets.com/research/qll444/intercept) has announced the addition of the "Intercept Pharmaceuticals' Obeticholic Acid - Clinical/regulatory update" report to their offering. Obeticholic acid (OCA) is a derivative of chenodeoxycholic acid, the dominant component of bile. It is a potent stimulator of farnesoid X receptor and in that way differs both from chenodeoxycholic acid and ursodeoxycholic acid (URSO), another bile acid used therapeutically. Intercept is developing OCA for use in a variety of liver diseases. Primary biliary cirrhosis (PBC), an orphan inflammatory disease of bile ducts, is the lead indication. But non-alcoholic steatohepatitis (NASH), a liver disorder that substantively overlaps with the epidemiology and pathophysiology of the metabolic syndrome is close behind. Intercept has also initiated/reported pilot efforts in bile acid diarrhea (BAD), acute alcoholic hepatitis, and portal hypertension. This report explores recent developments in these programs in depth, with an eye toward the complex regulatory situation they face. That is, no clear precedents exist and the adverse outcomes one wishes to avoid via therapy are long term. Especially for NASH, the population needing treatment is large and the ability to identify those who will have poor outcomes is difficult. Safety concerns complicate the picture further. Thus, endpoint selection and FDA's acceptance of data showing impact on those measures becomes a central issue when assessing the probabilities of regulatory success. Key Topics Covered: Introduction and background Primary biliary cirrhosis (PBC) - The disease (Medscape.com) - Phase II, including long-term extension data (ICPT 2013 10-K) - POISE (ICPT March 16 release) - Accelerated Approval in PBC and surrogates of transplant-free survival - Will one study be enough? - In summary Non-alcoholic steatohepatitis (NASH) NAFLD and NASHa brief review - Phase II study in diabetic NAFLD - The FLINT study - Endpoint issues and approval pathways for NASH - In summary - Update on lipid changes in phase II studies of fatty liver - Update on other indications Summary opinion - PBC - NASH - Other indications - In conclusion For more information visit http://www.researchandmarkets.com/research/qll444/intercept (full story)
Research and Markets: Intercept Pharmaceuticals' Obeticholic Acid for Liver Diseases Report
Business Wire - Fri May 23, 3:01AM CDT
Research and Markets (http://www.researchandmarkets.com/research/rh9xhp/intercept) has announced the addition of the "Intercept Pharmaceuticals' Obeticholic Acid for Liver Diseases" report to their offering. (full story)
Intercept Pharmaceuticals' Obeticholic Acid for Liver Diseases Report
M2 - Fri May 23, 2:03AM CDT
Research and Markets (http://www.researchandmarkets.com/research/bfcxg8/intercept) has announced the addition of the "Intercept Pharmaceuticals' Obeticholic Acid for liver diseases" report to their offering. Obeticholic acid (OCA) is a derivative of chenodeoxycholic acid, the dominant component of bile. It is a potent stimulator of farnesoid X receptor and in that way differs both from chenodeoxycholic acid and ursodeoxycholic acid (URSO), another bile acid used therapeutically. Intercept is developing OCA for use in a variety of liver diseases. Primary biliary cirrhosis (PBC), an orphan inflammatory disease of bile ducts, is the lead indication. But non-alcoholic steatohepatitis (NASH), a liver disorder that substantively overlaps with the epidemiology and pathophysiology of the metabolic syndrome is close behind. Intercept has also initiated/reported pilot efforts in bile acid diarrhea (BAD), acute alcoholic hepatitis, and portal hypertension. This initiation report explores these programs in depth, including the underlying rationale for use and a review of the phase II data in the lead PBC and NASH indications. It also explores issues related to the later phase trials for those indications, including the selection of endpoints. In PBC and especially in NASH, the ability to identify those who will have poor long-term outcomes (and thus would benefit from therapy) is difficult. Thus, endpoint selection and FDA's acceptance of data showing impact on those measures becomes a central issue when assessing the probabilities of regulatory success. The report also reviews the rationale and available data from the other programs and also looks at the competitive landscapes for each. Key Topics Covered: 1. Primary biliary cirrhosis (PBC) - The disease - Phase II, including long-term extension data (ICPT 2013 10-K) - POISE - Accelerated Approval in PBC and surrogates of transplant-free survival - Will one study be enough? - In summary 2. Non-alcoholic steatohepatitis (NASH) - NAFLD and NASHa brief review - Phase II study in diabetic NAFLD - The FLINT study - Endpoint issues and approval pathways for NASH - Update on lipid changes in phase II studies of fatty liver 3. Update on other indications 4. Summary opinion - PBC - NASH - Other indications Companies Mentioned - Albireo - Antipodean Pharmaceuticals - Intercept Pharmaceuticals - Johnson & Johnson - Kotobuki Pharmaceuticals - NovImmune - Phenex For more information visit http://www.researchandmarkets.com/research/bfcxg8/intercept About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. (full story)
Intercept Sinks on Cholesterol Issue - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Wed May 21, 4:12PM CDT
Intercept Pharmaceuticals (ICPT) shares tumbled 14.1% after a report from The Street disclosed that the company had information about the occurrence of abnormal cholesterol levels in its phase IIb study on obeticholic acid. (full story)
Today's Dead Cat Bounce Stock Is Intercept Pharmaceuticals (ICPT)
at The Street - Wed May 21, 8:52AM CDT
Trade-Ideas LLC identified Intercept Pharmaceuticals (ICPT) as a "dead cat bounce" (down big yesterday but up big today) candidate (full story)
Intercept Pharma, Government Scientists Spar Over Negative Safety of Liver Drug, Emails Show
at The Street - Tue May 20, 5:00AM CDT
Intercept Pharmaceuticals knew last January that abnormal cholesterol levels in patients contributed to the early stopping of a clinical trial involving its liver disease drug obeticholic acid, or OCA, but the company chose not to tell investors and... (full story)
