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April 11, 2014
09:08 EDTICPTIntercept announces OCA preclinical study data
Intercept announced results from a preclinical study demonstrating the potential protective effects of obeticholic acid, or OCA, in an experimental model of liver disease. The study was presented orally during the opening session of the International Liver Congress 2014, the 49th Annual Meeting of the European Association for the Study of the Liver. The study has also been selected as the best oral abstract in Basic Science at ILC 2014. In the study, OCA administration was shown to have protective effects on bacterial translocation from the ileum in an experimental rat model of cholestasis. The six animals receiving OCA treatment experienced significant reduction of bacteria in mesenteric lymph nodes and all but one of these remained free from bacterial infection in the abdominal cavity. In contrast, all six animals in the control group developed an abdominal infection. OCA treatment was additionally associated with normalized intestinal permeability, along with reduced inflammation of the lymph nodes and spleen. This study is the first to show OCA treatment limits bacterial translocation from the small intestine. In patients with liver cirrhosis, this manifests as spontaneous bacterial peritonitis.
News For ICPT From The Last 14 Days
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November 18, 2015
07:42 EDTICPTIntercept PBC treatment revenue likely to beat expectations, says Oppenheimer
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November 15, 2015
15:08 EDTICPTIntercept reports analysis of Phase 3 obeticholic acid study, other data
Intercept announced results from three studies in primary biliary cirrhosis, recently renamed primary biliary cholangitis, for presentation at the American Academy for the Study of Liver Diseases annual meeting. The studies evaluate investigational use of obeticholic acid, Intercept's lead farnesoid X receptor agonist. In a presentation titled, "Clinical Epidemiology of Primary Biliary Cirrhosis based on a Large U.S. Laboratory Database: Incidence and Trends in Serum Alkaline Phosphatase," an analysis of a clinical database of more than 575,000 patients who received an anti-mitochondrial antibody test showed that, of those patients, 6,107 were classified as having probable PBC based on a positive AMA test and ALP greater than the upper limit of normal at any time prior to AMA testing or up to one month following AMA testing. The study found that 69% of those likely PBC patients continued to have elevated ALP two years after the first positive AMA test. Meanwhile, a presentation titled "A Trial-Based Model of Liver Transplant and Liver-Related Death in Patients with Primary Biliary Cirrhosis" includes an analysis of data from the Phase 3 POISE trial of OCA in PBC using the UK-PBC predictive model of transplant-free survival based on ALP, bilirubin, alanine transaminase, albumin and platelet count. Risk was assessed at 5, 10 and 15 years based on a 12-month change from baseline in patients treated with OCA plus or minus ursodiol or placebo plus or minus ursodiol at the end of the POISE study. The UK-PBC risk algorithm showed a significantly lower risk of liver transplant or liver-related death in OCA-treated patients compared to placebo. Lastly, a presentation titled "Physician versus Patient Perceptions of Medical Care Quality in Primary Biliary Cirrhosis" showed that patients may not be properly informed about their ALP scores and the nature of PBC symptoms.
14:38 EDTICPTIntercept reports analyses of OCA in fatty liver patients
Intercept Pharmaceuticals announced new results from the non-invasive evaluation of liver fibrosis in patients from the FLINT trial of obeticholic acid, or OCA, for the treatment of nonalcoholic steatohepatitis, or NASH. In the trial, treatment with once daily 25 mg OCA was shown to reverse fibrosis in a "significant proportion" of biopsy-proven NASH patients, as observed by repeat liver biopsy at the end of the double-blind treatment phase at week 72, according to the company. Post-hoc analysis evaluated the early predictive value of three known non-invasive fibrosis tests -- FIB-4, APRI and NFS -- in identifying patients who experienced improvement in fibrosis. Each was assessed at baseline and over the course of treatment and then correlated with histologic changes observed in the OCA and placebo patients. The analysis demonstrated that OCA treatment of NASH patients led to a statistically significant decrease in FIB-4 from baseline as compared to placebo. Further, a decline in FIB-4 of 10% after 24 weeks of treatment predicted improvement in fibrosis by at least one stage as assessed by biopsy at 72 weeks, according to Intercept. Similarly, OCA-treated patients experienced a significant decrease in APRI as compared to placebo, and a 34% reduction in APRI at 24 weeks predicted improvement in fibrosis by at least one stage at 72 weeks. On average, OCA treatment reduced the FIB-4 score to less than 1.3 and the APRI score to less than 0.5, the respective cut-off values associated with advanced fibrosis, while placebo patients remained above these cut-offs. While NFS declined in the OCA-treated patients and increased in the placebo patients, it did not appear to be sensitive to changes in fibrosis, the company said.
November 13, 2015
15:35 EDTICPTIntercept to host investor meeting
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08:28 EDTICPTAmerican Association for Study of Liver Diseases to hold annual meeting
The Liver Meeting 2015 is being held in San Francisco on November 13-17.
November 11, 2015
16:26 EDTICPTOn The Fly: Top stock stories for Wednesday
Stocks on Wall Street finished the day lower following a range-bound session marked by lighter than normal volume due to the Veteran's Day holiday. The lower participation allowed the market to digest the latest round of earnings with the reporting season beginning to wind down. Oil remained under pressure and closed near three week lows, as production has not really declined despite lower pricing. ECONOMIC EVENTS: In the U.S., the economic calendar was quiet with no major data reported. U.S. bond markets were closed in observance of Veteran's Day. In China, industrial output rose 5.6% in October, matching March's reading as the weakest since 2008. Retail sales climbed 11% last month, beating expectations. COMPANY NEWS: Shares of Alibaba Group (BABA) trading in New York fell $1.62, or 1.98%, to $79.81 despite its report of blockbuster sales for the 11.11 shopping festival, better known as "Singles' Day." By the end of Wednesday in China, gross merchandise volume on Alibaba's platforms hit $14.3B, far exceeding last year's 24-hour total of $9.3B and topping the company's $11B forecast... Macy's (M) shares fell 14% to $40.41 after the department store operator cut its fiscal year sales and profit forecasts and said it would not follow an activist investor's suggestion to form a real estate investment trust. A number of its peers fell as well, including J.C. Penney (JCP), which dipped 1.9% despite previewing that its own quarterly results should be better than its prior expectations. Penney, which pre-announced stronger than expected same-store sales growth of 6.4% for Q3, is set to report full quarterly results on Friday morning... Anheuser-Busch InBev (BUD) and SABMiller (SBMRY) came to terms on a deal to combine the companies in a transaction worth $107B. In relation to their deal, Molson Coors (TAP) agreed to purchase SABMiller's 58% stake in MillerCoors, the joint venture formed in the United States in 2008, in a deal valued at $12B. Molson Coors was the biggest winner following today's announcements, rising 4.4% to $92.19. MAJOR MOVERS: Among the notable gainers was Atmel (ATML), which rose 33c, or 4.39%, to $7.85 after Dialog Semiconductor (DLGNF) issued a statement saying it continues to "strongly" support its agreement to acquire the company. Also higher was Amazon (AMZN), which gained $14.18, or 2.15%, to $673.86 after research firm Morgan Stanley raised its price target on the name to $800 from $750 on the growing opportunity of Amazon Web Services. Separately, Wayfair (W) rallied 5.4% to $41.57 after Cowen analysts raised their target on the shares to $61 from $56 and reiterated an Outperform rating, calling Tuesday's selloff misguided. Among the noteworthy losers were Horizon Pharma (HZNP) and Insys (INSY), which declined a respective 19.6% and 8.7% after Express Scripts (ESRX) cut ties with Linden Care, a specialty pharmacy used by both companies. Also lower was PayPal (PYPL), which fell 67c, or 1.81%, to $36.33 shortly before the close after the Wall Street Journal reported that Apple (AAPL) is working on a mobile payments service that could compete with the firm's Venmo platform. Additionally, Intercept (ICPT) lost $24.02, or 11.66%, to $181.95 after FBR Capital cut its price target on the stock to $192 from $273, saying the market opportunity for Intercept's obeticholic acid liver disease candidate appears smaller than initially thought. INDEXES: The Dow dropped 55.99, or 0.32%, to 17,702.22, the Nasdaq slid 16.22, or 0.32%, to 5,067.02, and the S&P 500 declined 6.72, or 0.32%, to 2,075.00.
09:29 EDTICPTIntercept price target lowered to $192 from $273 at FBR Capital
FBR Capital analyst Vernon Bernardino cut his price target for Intercept Pharmaceuticals to $192 and keeps a Market Perform rating on the name. The market opportunity of the company's investigational liver disease drug, obeticholic acid, is smaller than initially estimated, Bernardino admits in a research note. The analyst now believes OCA will achieve $2.2B in peak annual sales in non-alcoholic steatohepatitis, versus a prior estimate of $2.7B. His reduced forecast is based on the likelihood of Intercept having inadequate long-term safety data in NASH. Shares of Intercept closed yesterday at $205.97.

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