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Stock Market & Financial Investment News

News Breaks
March 17, 2014
08:50 EDTICPTIntercept says FDA has not reported concern over FLINT trial to company
Intercept said the FDA has not report any concern to the company regarding the FLINT trial. Intercept said the cardiovascular events in the FLINT trial brought to light by the company in its filing occurred over the course of the trial and the last of them occurred prior to Mid 2013, about seven months before the positive interim efficacy analysis lead to the decision to stop the FLINT treatment phase early. The company said that based on its understanding of the mechanism of action of OCA, its clinical safety experience with its drug, and the rates of cardiovascular morbidity and mortality it in NASH patients, particularly in those with Type II Diabetes and other cardiovascular risk factors, the company said it does not currently view the low incidence of the cardiovascular events reported in FLINT to be indicative of a safety signal. Comments from Intertecpt's Q4 earnings conference call.
News For ICPT From The Last 14 Days
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November 14, 2014
15:22 EDTICPTIntercept CEO says company 'very well-positioned' in terms of balance sheet
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November 12, 2014
12:00 EDTICPTKOLs say 'remains to be seen' if OCA can get accelerated approval, says Leerink
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11:55 EDTICPTIntercept not part of talks with journals, says Deutsche Bank
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November 11, 2014
12:00 EDTICPTIntercept results said to be rejected by New England Journal, Bloomberg says
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November 10, 2014
08:36 EDTICPTIntercept price target lowered to $125 from $172 at FBR Capital
FBR Capital lowered its price target for Intercept shares to $125 saying its talks with experts and cardiologists indicate the company's OCA drug is unlikely to be a "silver bullet" for the treatment of nonalcoholic steatohepatitis. FBR notes that while OCA appears to improve the liver, the drug worsens many of the other derangements like lipid and glucose homeostasis. FBR decreased the probability of success in NASH to 55% from 60%, and lowered its peak OCA sales estimate to $5.2B. It keeps an Underperform rating on Intercept shares.
November 9, 2014
11:56 EDTICPTIntercept announces additional data for OCA in primary biliary cirrhosis
Intercept Pharmaceuticals announced new analyses of data from clinical trials on obeticholic acid, OCA, in patients with primary biliary cirrhosis, PBC. Six posters, including posters with new analyses of data from POISE – the first Phase 3 trial in PBC in two decades – are being presented at today's poster session at the American Association for the Study of Liver Disease, AASLD, Annual Meeting. 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, primary sclerosing cholangitis, PSC, and other chronic liver diseases.
November 7, 2014
12:56 EDTICPTIntercept trading toward worst case scenario, says Deutsche Bank
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12:20 EDTICPTOn The Fly: Midday Wrap
Stocks on Wall Street opened in relatively quiet fashion and trading has remained that way throughout the morning. The highly anticipated nonfarm payrolls report showed fewer than expected jobs were added last month, but the figures from the prior two months were also upwardly revised. The market has moved in a narrow range and for the most part has remained near the flat line, with the S&P and Dow little changed and the Nasdaq lagging near noon. ECONOMIC EVENTS: In the U.S., nonfarm payrolls rose 214K in October, which was below the consensus estimate for 235K jobs to have been added. However, back revisions boosted September's job gain to 256K from the 248K previously reported, while August's prior 180K reading was pushed up to 203K. The unemployment rate slid to 5.8% from 5.9%, its lowest level since July 2008. Later this afternoon, the Federal Reserve Board’s report on consumer credit growth in September is expected, with total credit projected to grow $16B. COMPANY NEWS: Shares of Disney (DIS) led all decliners on the Dow, as the stock fell 2.5% after the company reported earnings and revenue for its fourth quarter that were nearly in-line with consensus estimates. Along with its report, the company confirmed 2015's Star Wars movie will be entitled "The Force Awakens" and announced plans for another sequel in the "Toy Story" franchise. MAJOR MOVERS: Among the notable gainers was ChannelAdvisor (ECOM), which rose 46% after delivering generally in-line Q3 results, giving better than expected fiscal year revenue guidance and announcing the acquisition of U.K. based E-Tale Holdings. Also higher were shares of Sears Holdings (SHLD), which jumped 26% after the company disclosed it is actively exploring a REIT transaction involving 200-300 owned properties through a rights offering to shareholders. Among the noteworthy losers was Salix (SLXP), which plunged 36% and was downgraded by at least four firms after the company reported worse than expected Q3 results, gave lower than expected guidance and announced its CFO had resigned amid the company revising its view of the current inventory levels for its drugs. Also lower were shares of Intercept Pharmaceuticals (ICPT), which fell 33% after results from the FLINT trial evaluating obeticholic acid, or OCA, for the treatment of nonalcoholic steatohepatitis, or NASH, were published in The Lancet. Oppenheimer said it believes that data disclosed last night was in-line with previous data from Intercept, but that a Bloomberg story "cherry picked" negative aspects of the data, contributing to the share decline. INDEXES: Near midday, the Dow was virtually unchanged at 17,555.12, the Nasdaq was down 13.72, or 0.3%, to 4,624.75, and the S&P 500 was up 0.42, or 0.02%, to 2,031.63.
11:41 EDTICPTIntercept downgraded to Market Perform from Outperform at Leerink
10:15 EDTICPTIntercept weakness a buying opportunity, says Wedbush
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09:16 EDTICPTOn The Fly: Pre-market Movers
HIGHER: Sears (SHLD), up 22.5% after reporting Q3 same-store sales were flat with prior year, saying company is actively exploring a REIT transaction involving 200-300 owned properties through a rights offering... Gap (GPS), up 2.9% after reporting October same-store sales fell 3%, giving Q3 EPS guidance that beat estimates... Zynga (ZNGA), up 9%, upgraded at Needham following the company's Q3 earnings report... King Digital (KING), up 8.6% after Q3 results top expectations, company announces $150M share repurchase program... ChannelAdvisor (ECOM), up 30% after earnings, guidance, announcing acquisition of U.K. based E-Tale Holdings... Rockwell Medical (RMTI), up 25% after FDA committee recommends Triferic to treat iron loss in certain patients with chronic kidney disease... Repros Therapeutics (RPRX), up 23% following meeting with FDA regarding Androxal NDA filing. LOWER: Salix (SLXP), down 35%, downgraded at Mizuho, Stifel and William Blair after the company reported worse than expected Q3 earnings, gave lower than expected guidance and announced its CFO had resigned... Intercept (ICPT), down 19% after FLINT trial results published... CTI BioPharma (CTIC), down 20% after filing convertible preferred stock offering... Transocean (RIG), down 5% after delaying its Q3 earnings release and conference call, stating the company expects Q3 to include a non-cash charge of $1.97B for impairment of goodwill... General Mills (GIS), down 4% after lowering FY15 outlook. DOWN AFTER EARNINGS: Abercrombie & Fitch (ANF), down 12.6%... Ubiquiti Networks (UBNT), down 17%... Arista Networks (ANET), down 10.5%... First Solar (FSLR), down 6%... Magnum Hunter (MHR), down 2%.
08:55 EDTICPTIntercept says has pre-NDA meeting 'coming up' with FDA
Intercept says it will need aspects of the complete data set from FLINT to complete the NDA, but that it already has "a lot" of the data it needs from FLINT. Intercept said it plans to study how cholesterol can be managed with statins in conjunction with the use of obeticholic acid for NASH.
08:53 EDTICPTIntercept shares should be bought on any weakness, says Oppenheimer
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08:37 EDTICPTIntercept says 'premature' to guess what FDA will require
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08:29 EDTICPTIntercept repeats two deaths in OCA group not considered related to treatment
In the FLINT trial evaluating obeticholic acid, or OCA, for the treatment of nonalcoholic steatohepatitis, or NASH, two deaths occurred in the OCA treatment group, as previously disclosed, but neither were considered related to OCA treatment, Intercept said. Consistent with earlier reported results, OCA treatment was associated with cholesterol changes that developed within 12 weeks of treatment initiation, then began reversing through the end of treatment and returned to baseline during the 24-week post-treatment follow-up phase. Based on these observations, lipid management was emphasized partway into the trial, using generally accepted guidelines, the company said. OCA was generally well tolerated and adverse events were generally mild to moderate in severity and the incidence in the OCA and placebo treatment groups was similar for all symptoms except pruritus. Pruritus in the OCA treatment group occurred more frequently, 23% vs 6%, at a higher grade and resulted in one patient discontinuation.
08:25 EDTICPTIntercept says direct comparison of FLINT and PIVENS trials 'unsound'
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06:49 EDTICPTIntercept to host investor meeting
Investor meeting to be held on November 10 at 6:30 pm. Webcast Link
06:43 EDTICPTIntercept to host conference call
Conference call to discuss FLINT update will be held on November 7 at 8 am. Webcast Link

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