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August 12, 2014
16:32 EDTDNDN, KATE, ICPT, TRAK, KORSOn The Fly: Closing Wrap
Stocks on Wall Street began the session in negative territory and remained there for most of the session. The averages moved in a narrow range as the summer doldrums have set in, leaving little in the way of both volume and volatility. ECONOMIC EVENTS: In the U.S., the NFIB's small business confidence index rose 0.7% to 95.7 in July, though that was below the expectation for a 96.0 reading. The Job Openings and Labor Turnover Survey showed job openings rose 94K to 4.671M in June. The Treasury posted a $94.6B budget deficit in July, which was not as steep as the $96.0B deficit that was projected. In Germany, the ZEW Center's economic sentiment index fell to 8.6 in August from 27.1 in July, compared to the consensus forecast for a decrease to 17. COMPANY NEWS: Accessory and clothing retailer Kate Spade (KATE) initially advanced in pre-market trading and was higher early in the session after the company reported second quarter adjusted earnings per share and sales that beat analysts' consensus forecast. However, the stock reversed and moved into negative territory during the company's associated conference call, during which it said it was "responsible to reevaluate the timeframe" to achieve its previously laid out targets for 2016, citing a longer than expected Kate Spade Saturday ramp-up, its revised 2014 margin rate outlook, and the company's limited visibility into 2016. For the day, the stock declined $9.87, or 25.39%, to $29.00. MAJOR MOVERS: Among the notable gainers was Intercept Pharmaceuticals (ICPT), which rose $39.34, or 16.59%, to $276.52 after data from a trial of its liver disease drug OCA showed improved safety as well as a statistical benefit in reversing liver fibrosis. Also higher was DealerTrack (TRAK), which advanced $7.32, or 18.73%, to $46.40 after the company reported higher than expected second quarter earnings and raised its 2014 EPS outlook. Among the noteworthy losers was Dendreon (DNDN), which dropped 72c, or 33.96%, to $1.40 after reporting its Q2 revenue in a regulatory filing and disclosing the company sees a "significant risk" that it will not be able to repay or refinance its 2016 Notes. The company also acknowledged it is currently considering alternatives to the repayment of the 2016 Notes, some of which could result in leaving its current stockholders "with little or no financial ownership of Dendreon." Also lower were shares of Michael Kors (KORS), which fell $2.55, or 3.19%, to $77.44 in a potential reaction to the cautious margin guidance and commentary about the promotional retail environment from peer Kate Spade. INDEXES: The Dow fell 9.44, or 0.06%, to 16,560.54, the Nasdaq dropped 12.08, or 0.27%, to 4,389.25, and the S&P 500 slid 3.17, or 0.16%, to 1,933.75.
News For KATE;KORS;ICPT;DNDN;TRAK From The Last 14 Days
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November 27, 2015
06:39 EDTKORSPiper says Deckers, GoPro look more promotional than last year
After visiting malls and big box retailers during the initial 6 PM store openings last night, Piper Jaffray analyst Erinn Murphy says brands that appear more promotional than last year include Deckers Outdoor (DECK), GoPro (GPRO), Michael Kors (KORS), Ralph Lauren (RL), Steven Madden (SHOO) and Under Armour (UA). Customer traffic "was robust" at the open on Thanksgiving, Murphy tells investors this morning in a research note. She views the "must-have" items as being in the electronics and cosmetics spaces.
November 18, 2015
07:42 EDTICPTIntercept PBC treatment revenue likely to beat expectations, says Oppenheimer
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November 17, 2015
07:52 EDTKORSMorgan Stanley to hold a conference
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November 16, 2015
16:43 EDTKORSGreenlight Capital added Apple, sold some SunEdison
Greenlight Capital gave a quarterly update on its stakes in a filing this afternoon. NEW STAKES: CNX Coal Resources (CNXC), Garmin (GRMN), Terraform Global (GLBL), and Liberty Global (LILA). INCREASED STAKES: Apple (AAPL), Michael Kors (KORS), Dillard's (DDS), UIL Holdings (UIL), and Twenty-First Century Fox (FOXA). DECREASED STAKES: SunEdison (SUNE), Micron (MU), Voya (VOYA), Applied Materials (AMAT), and SunEdison Semiconductor (SEMI). LIQUIDATED STAKES: Citizens Financial (CFG), Lam Research (LRCX), Spirit AeroSystems (SPR), Hertz (HTZ), and Macy's (M).
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.

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