Key Developments: Amarin Corporation PLC (AMRN.A)

AMRN.A on American Stock Exchange

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Latest Key Developments (Source: Significant Developments)

Amarin Corporation PLC announces publication of case study results describing reductions in multiple lipid parameters for individual Hyperlipidemic patients switched to Vascepa
Wednesday, 11 Jun 2014 07:00am EDT 

Amarin Corporation PLC:Publication of retrospective analysis of patient cases that examined effect on lipid parameters in hyperlipidemic patients who were switched from Lovaza  (omega-3-acid ethyl esters) capsules, a mixture of omega fatty acids.Says to Vascepa  (icosapent ethyl) capsules, the only pure-EPA prescription omega-3 product, to potentially achieve better outcomes in triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C) levels.1 During studied period of 14 patients switched to Vascepa experienced reductions in levels of triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and non-high-density lipoprotein cholesterol (non-HDL-C).Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.Effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.  Full Article

Amarin Corporation PLC Presents new MARINE and ANCHOR Post-Hoc Analyses showing Vascepa significantly reduced Apolipoprotein C-III Levels
Friday, 2 May 2014 08:00am EDT 

Amarin Corporation PLC:Presentation of new post-hoc analyses of the MARINE and ANCHOR studies that showed the use of Vascepa (icosapent ethyl) capsules significantly reduced apolipoprotein C-III (ApoC-III) levels.ApoC-III is small protein that resides on various lipoproteins, and is important regulator of lipoprotein and triglyceride (TG) metabolism.Significantly reduced Apo C-III levels with Vascepa in MARINE and ANCHOR trials add to previously reported TG- and ApoB-lowering effects in patients from these studies.MARINE and ANCHOR were 12-week, phase 3, double-blind studies that randomized patients to Vascepa 4 g/day, 2 g/day, or placebo.MARINE randomized 229 patients with TG 500 and 2000 mg/dL while ANCHOR randomized 702 patients at high risk for cardiovascular disease with TG 200 and < 500 mg/dL despite low-density lipoprotein cholesterol (LDL-C) control while on statin therapy.In MARINE study, stable statin therapy was permitted but not required.In ANCHOR study, patients were required to be at high risk for cardiovascular disease as defined by the NCEP ATP III guidelines and on stable statin dose (atorvastatin, rosuvastatin, or simvastatin).Vascepa (icosapent ethyl) capsules, known in scientific literature as AMR101, is a patented, pure-EPA omega-3 prescription product in a 1 gram capsule.  Full Article

Amarin Corporation PLC and Kowa Pharmaceuticals America, Inc. announces U.S. co-promotion agreement for VascepaCapsules
Monday, 31 Mar 2014 04:30pm EDT 

Amarin Corporation PLC and Kowa Pharmaceuticals America, Inc:Agreement to co-promote Amarin's flagship product, Vascepa (icosapent ethyl) capsules, in United States.Vascepa is approved for use in United States as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.  Full Article

Amarin Corporation PLC announces appointment of auditor - Form 8-K
Thursday, 6 Mar 2014 05:01pm EST 

Amarin Corporation PLC:Says the engagement of Ernst & Young LLP as the independent auditor for the fiscal year ending Dec. 31.  Full Article

Amarin Corporation PLC announces FDA award of three-year exclusivity for Vascepa capsules
Friday, 21 Feb 2014 04:01pm EST 

Amarin Corporation PLC:U.S. Food and Drug Administration has awarded three years of marketing exclusivity to Vascepa capsules in connection with the July 26, 2012 approval of Vascepa pursuant to the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act.Such exclusivity extends through July 25, 2015 and is expected to be supplemented by a 30-month stay under the Hatch-Waxman Amendments that would be triggered after patent infringement litigation initiated by Amarin following.FDA marketing exclusivity is separate from, and in addition to, patent protection.Trade secrets and manufacturing barriers to entry which also help protect Vascepa against generic competition.  Full Article

Amarin Corporation PLC announces FDA review division response to ANCHOR SPA agreement reinstatement request
Tuesday, 21 Jan 2014 01:00am EST 

Amarin Corporation PLC:Says that the division of Metabolism and Endocrinology Products (DMEP) within the U.S. Food and Drug Administration (FDA) has notified Amarin in connection with Amarin's request for reconsideration of DMEP's Oct. 2013.decision to rescind the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement that DMEP 'does not plan to re-instate the ANCHOR SPA agreement.Says that in its communication to Amarin, DMEP stated that information submitted by Amarin supports testing the hypothesis that Vascepa (icosapent ethyl) 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.Says 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.  Full Article

Amarin Corporation PLC says FDA delays decision on Vascepa trial design-Reuters
Wednesday, 15 Jan 2014 05:55pm EST 

Amarin Corporation PLC:Says U.S. health regulators delayed their decision to reconsider a rescinded agreement that could support a marketing application for an expanded use of the company's blood fat-lowering drug-Reuters.Says the U.S. Food and Drug Administration had in October revoked a Special Protocol Assessment (SPA) agreement covering a large late-stage trial of the drug, Vascepa.Says following an appeal from Amarin, the regulator said it would determine by Jan 15 whether it would reconsider that decision.  Full Article

Amarin Corporation PLC announces leadership changes
Monday, 16 Dec 2013 09:03am EST 

Amarin Corporation PLC:Says the appointment of current President, John F. Thero, as President and Chief Executive Officer of the company, effective Jan 1, 2014.Says these appointments follow communication to the Board of Directors by Joseph S. Zakrzewksi of his intention to retire as Chief Executive Officer and Chairman of the Board of Directors of Amarin.In connection with Zakrzewski's retirement, Lars Ekman, who currently serves as Lead Independent Director, will become Chairman of the board, effective Jan 1, 2014.  Full Article

Howard G. Smith files class action lawsuit against Amarin Corporation plc
Wednesday, 27 Nov 2013 09:32pm EST 

Howard G. Smith:Says a class action lawsuit has been filed in the United States District Court for the Southern District of New York on behalf of a class comprising all purchasers of the common, call options or sellers of put options of Amarin Corporation plc between July 9, 2009 and Oct. 15, 2013, inclusive.  Full Article

Rigrodsky & Long, P.A. Files Securities Fraud Class Action Against Amarin Corporation plc
Friday, 22 Nov 2013 01:32pm EST 

Rigrodsky & Long, P.A., including former Special Assistant United States Attorney, Timothy J. MacFall, announced that a complaint has been filed in the United States District Court for the Southern District of New York on behalf of all persons or entities that purchased the common stock of Amarin Corporation plc (Amarin or the Company) between July 9, 2009 and October 16, 2013, inclusive (the Class Period), alleging violations of the Securities Exchange Act of 1934 against the Company and certain of its officers (the Complaint). The Complaint alleges that throughout the Class Period, defendants made materially false and misleading statements, and omitted materially adverse facts, about the Company's business, operations and prospects. Specifically, the Complaint alleges that the defendants concealed from the investing public that: (1) the Company's prospects for U.S. Food and Drug Administration's ("FDA") approval of its lead product, Vascepa, were misleading; and (2) the Company failed to disclose that the FDA had informed Amarin that there was a lack of prospective, controlled clinical trial data indicating that the pharmaceutical reduction of triglycerides ("TG") reduces residual cardiovascular risk. As a result of defendants` false and misleading statements, the Company's stock traded at artificially inflated prices during the Class Period.  Full Article

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