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Stock Market & Financial Investment News

News Breaks
January 21, 2014
05:13 EDTAMRNAmarin announces FDA DMEP 'does not plan to reinstate ANCHOR SPA agreement'
Amarin announced that the Division of Metabolism and Endocrinology Products, or DMEP, within the FDA has notified Amarin in connection with Amarin's request for reconsideration of DMEP's October 2013 decision to rescind the ANCHOR clinical trial Special Protocol Assessment, or SPA, agreement that DMEP "does not plan to re-instate the ANCHOR SPA agreement." In its communication to Amarin, DMEP stated that information submitted by Amarin supports testing the hypothesis that Vascepa 4 grams/day versus placebo reduces major adverse cardiovascular events in statin-treated subjects with residually high triglyceride levels, as is being studied in the Vascepa REDUCE-IT cardiovascular outcomes study. However, DMEP reiterated its position expressed at the October 2013 Vascepa advisory committee meeting that currently available data from studies of other therapies do not support use of drug-induced reductions in serum triglycerides as a basis for approval of an indication that DMEP views as ostensibly and impliedly an indication to reduce the risk of cardiovascular disease. Prior to being able to appeal DMEP's October 2013 decision to rescind the ANCHOR SPA agreement, FDA protocol requires that DMEP first be given a formal opportunity for reconsideration. With that step now completed, Amarin plans to appeal the DMEP decision to the FDA Director of the Office of Drug Evaluation II, or ODE-II, the next level under FDA dispute resolution guidance. Based on information available to Amarin, Amarin does not expect a determination on the pending ANCHOR sNDA while Amarin prepares its appeal or while this appeal is pending. Amarin also plans to continue its efforts toward a positive determination on the pending ANCHOR sNDA.
News For AMRN From The Last 14 Days
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September 16, 2014
05:59 EDTAMRNAmarin to host conference call
Conference call to discuss its commitment to the REDUCE-IT study will be held on September 16 at 8 am. Webcast Link
05:34 EDTAMRNAmarin commits to completing REDUCE-IT cardiovascular outcomes study
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September 12, 2014
16:20 EDTAMRNOn The Fly: Closing Wrap
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14:59 EDTAMRNAmarin weakness an overreaction, says Citigroup
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12:51 EDTAMRNOn The Fly: Midday Wrap
Stocks on Wall Street opened in negative territory and have remained there throughout the morning. The day’s economic data, including retail sales figures, a report on import prices, and business inventories data, were generally in line with expectations. The economic bright spot was the University of Michigan consumer confidence report which came in higher than expected. The market is on the verge of ending the week lower, which would be its first weekly loss in the last seven. ECONOMIC EVENTS: In the U.S., sales at retailers climbed 0.6% in August, matching expectations but also representing the fastest pace in four months. Retail sales growth for July was also revised upward to 0.3% from a prior estimate of having been flat. Import prices dropped 0.9% in August, while export prices slipped 0.5%. The University of Michigan preliminary consumer sentiment reading for for September rose to 84.6, beating expectations for it to be up more modestly to 83.3. Business inventories grew 0.4% in July, as expected. COMPANY NEWS: Shares of eBay (EBAY) were up more than 2% near noon after rumors circulated that Google (GOOG) may look to take a stake in the company. However, an eBay spokesperson denied the speculation, telling Reuters that the company has held "no conversations" with Google about acquiring a stake. MAJOR MOVERS: Among the notable gainers was digital marketing services company Conversant (CNVR), which soared 30% after Alliance Data Systems (ADS) agreed to acquire it for about $2.3B in cash and stock. Following last night's announcement of the deal, some Conversant peers rose as well, as Criteo (CRTO) gained almost 5% and TubeMogul (TUBE) rose 1%, while Alliance Data gained over 2%. Among the noteworthy losers was Amarin (AMRN), which dropped 22% after an office within the FDA denied the company's appeal of FDA's rescission of the ANCHOR clinical trial Special Protocol Assessment agreement. Also lower were shares of Ruckus Wireless (RKUS), which fell 5% after one analyst downgraded the shares and another initiated coverage of the stock with an Underweight rating. INDEXES: Near midday, the Dow was down 66.43, or 0.39%, to 16,982.57, the Nasdaq was down 19.83, or 0.43%, to 4,571.97, and the S&P 500 was down 10.28, or 0.51%, to 1,987.17.
10:10 EDTAMRNHigh option volume stocks
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09:14 EDTAMRNOn The Fly: Pre-market Movers
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09:04 EDTAMRNAmarin down 24.3% after FDA office denies appeal of ANCHOR rescission
09:03 EDTAMRNAmarin says FDA office denies appeal of ANCHOR rescission
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09:02 EDTAMRNAmarin says FDA office denies appeal of ANCHOR rescission
September 10, 2014
14:17 EDTAMRNAmarin says Vascepa SPA rescission appeal on ANCHOR sNDA ongoing
Amarin says it is appealing to a higher level and if appeal is not successful that the company may pursue judicial relief under the First Amendment. Amarin says that the fight over Vascepa's sNDA for a mixed dyslipidemia indication is an "uphill battle," but the company believes patient care would benefit and that the company has valid legal, clinical and regulatory arguments. Information from slides for the company's presentation at the Rodman & Renshaw Global Investment conference.

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