Wired News – Amarin’s REDUCE-IT Study Reached 100% Mark for Estimated Onset of Targeted Primary MACE
Stock Monitor: Pernix Therapeutics Holdings Post Earnings Reporting
LONDON, UK / ACCESSWIRE / April 6, 2018 / Active-Investors.com has just released a free research report on Amarin Corp. PLC (NASDAQ: AMRN). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=AMRN as the Company’s latest news hit the wire. On April 04, 2018, the Company announced that its REDUCE-IT cardiovascular outcomes study of Vascepa® (icosapent ethyl) has reached the targeted number of 1,612 primary major adverse cardiovascular events (MACE) specified in the study design. The REDUCE-IT cardiovascular outcomes study began with patient dosing at the end of 2011. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Amarin most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
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The 1,612 Events to Meet Criteria for 90% Power to Detect a 15% Relative Reduction in MACE Risk
Completion of the REDUCE-IT study does not require reaching exactly 1,612 MACE, and the actual number of events is likely to differ from this study design target. The powering assumptions for the study were based on 1,612 MACE with 90% power to demonstrate a 15% relative risk reduction. A final cumulative MACE tally from the inception date of the study which is slightly above or below 1,612 MACE will not have a significant impact on the overall powering of the study results.
Top-line Results from REDUCE-IT Study Expected in Q3 2018
The estimated onset of the targeted number of cardiovascular events in REDUCE-IT is based on documented events having exceeded 90% of target as reported in January 2018, subsequently reported MACE in the adjudication process, and projected events based on standard industry methodology. Amarin anticipates that MACE from the study will be adjudicated through Q2 2018, consistent with the Company’s objective of reporting top-line results from this important study before the end of Q3 2018.
Amarin is Nearing Conclusion of this Potentially Landmark Cardiovascular Outcomes Study
Commenting on the announcement, Dr. Steven Ketchum, President of R&D and Chief Scientific Officer of Amarin, stated that the Company is happy to be nearing the conclusion of this potentially landmark cardiovascular outcomes study.
Dr. Steven added that the Company will work diligently to rapidly roll-up and report the results of the study in the hope that such results can lead to the better informed preventative care of patients at high cardiovascular risk.
Amarin is intentionally blinded to the results of the study and will remain blinded to such results until after the study is completed and the database is locked.
About VASCEPA® Capsules
Vascepa® (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa® is not fish oil but is derived from fish through a stringent and complex FDA-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient. Vascepa®, known in scientific literature as AMR101, has been designated a new chemical entity by the FDA. Amarin has been issued multiple patents internationally based on the unique clinical profile of Vascepa®, including the drug’s ability to lower triglyceride levels in relevant patient populations without raising LDL-cholesterol levels.
About Amarin Corp. PLC
Founded in 1991 and headquartered in Dublin, Ireland, Amarin is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. The Company’s product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids.
Stock Performance Snapshot
April 05, 2018 – At Thursday’s closing bell, Amarin’s stock declined 4.11%, ending the trading session at $3.03.
Volume traded for the day: 2.23 million shares, which was above the 3-month average volume of 2.20 million shares.
After yesterday’s close, Amarin’s market cap was at $873.06 million.
The stock is part of the Healthcare sector, categorized under the Drug Manufacturers-Other industry.
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