Shares of Amarin Corporation plc (ADR) (NASDAQ:AMRN) ended Monday session in green amid volatile trading. The shares closed up +0.07 points or 2.64% at $2.72 with 1.94 million shares getting traded. Post opening the session at $2.65, the shares hit an intraday low of $2.64 and an intraday high of $2.74 and the price vacillated in this range throughout the day. The company has a market cap of $585.66 million and the numbers of outstanding shares have been calculated to be 205.65 million shares.
Amarin Corporation plc (ADR) (AMRN) on Sept. 12, 2016 announced that, as expected, the independent data monitoring committee (DMC) has completed its review of the first pre-specified interim efficacy analysis for the REDUCE-IT cardiovascular outcomes study and has recommended that the trial continue as planned without modification. The 8,175-patient outcomes study is evaluating whether treatment with Vascepa® (icosapent ethyl) reduces cardiovascular events in patients who despite stabilized statin therapy have elevated triglyceride levels and other cardiovascular risk factors.
In accordance with the study protocol, the first interim efficacy analysis was performed after adjudication of approximately 60% of the target 1,612 aggregate primary cardiovascular events occurred within the study. Preparations for a second planned interim efficacy analysis will be triggered by the onset of approximately 80% of the target aggregate number of primary cardiovascular events. Amarin anticipates that the onset of approximately 80% of events will occur in the first half of 2017, with the second pre-specified interim efficacy analysis and review by the DMC expected around mid-2017. Amarin will remain blinded to results of the study until after the study is stopped and the database is locked at either the second interim analysis or at the final analysis.
The DMC’s recommendation to continue as planned also reflects its review of all available safety data. In accordance with the study protocol and DMC charter, safety reviews have been performed multiple times each year since REDUCE-IT began in December 2011, and more than 23,000 patient years of study have been accumulated to date in the ongoing REDUCE-IT study. The review and recommendation of the DMC was made independently. Neither Amarin nor the FDA has reviewed the interim clinical results and neither participated in the DMC’s closed session deliberation.
Shares of Skyline Medical Inc (NASDAQ:SKLN) ended Monday session in green amid volatile trading. The shares closed up +0.007 points or 4.10% at $0.183 with 21.48 million shares getting traded. Post opening the session at $0.21, the shares hit an intraday low of $0.18 and an intraday high of $0.21 and the price vacillated in this range throughout the day. The company has a market cap of $14.71 million and the numbers of outstanding shares have been calculated to be 81.80 million shares.
Skyline Medical Inc (SKLN) on Sept. 21, 2016 announced the signing of a partnership and exclusive reseller agreement with GLG Pharma, LLC (“GLG”).
Under the terms of the agreement, GLG intends to develop rapid diagnostic tests that utilize fluid and tissue collected by the STREAMWAY System during procedures. Skyline Medical will issue common stock to GLG in four separate tranches, with each tranche released after the achievement of certain development milestones. In addition, Skyline will pay a royalty to GLG on the sale of individual tests.
Initial tests are anticipated to include cancer biomarkers and infectious diseases. The oncology test panels will feature GLG’s patented inhibitors of Signal Transducers and Activators of Transcription 3 (STAT3), which are in preclinical development for a new generation of targeted therapies.
“This partnership provides Skyline Medical with access to exciting new technology that we believe will allow future enhancements in the collection of cells and fluid waste and how it is utilized prior to disposal,” said Dr. Carl Schwartz, Interim Chief Executive Officer of Skyline Medical. “The first of these developments may include point-of-care companion testing that assists oncologists, both in operating rooms and in interventional radiology suites, in personalizing treatments based on results of the fluid collected. In addition, testing of the cells that are sloughed off during procedures may provide physicians with valuable information as to the progress of a surgery. The sale of diagnostic tests in conjunction with STREAMWAY provides an attractive opportunity to leverage our sales and marketing organization, while providing both new and enhanced sources of revenue to Skyline.”