Amarin Corp. PLC (NASDAQ: AMRN) shares absolutely skyrocketed on Monday after the company announced top-line results from the Vascepa cardiovascular (CV) outcomes trial, REDUCE-IT. Needless to say, the results were very positive.
Overall, the trial met its primary endpoint of demonstrating an approximately 25% relative risk reduction, to a high degree of statistical significance, in major adverse CV events in the intent-to-treat patient population with use of Vascepa 4 grams per day as compared to placebo.
Vascepa was well tolerated, with a safety profile consistent with clinical experience associated with omega-3 fatty acids and current FDA-approved labeling. The proportions of patients experiencing adverse events and serious adverse events in REDUCE-IT were similar between the active and placebo treatment groups.
Considering the successful topline results of REDUCE-IT, Amarin is in the process of increasing the number of company sales representatives promoting Vascepa to over 400 people in the United States. This will provide a greater concentration of coverage in current sales territories and provide new coverage where Amarin currently does not have sales representatives.
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In addition to sales force expansion in the United States, Amarin plans to work with its international partners to support regulatory efforts outside the United States based on REDUCE-IT results.
Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Amarin, commented:
Considered against the backdrop of multiple unsuccessful cardiovascular outcomes studies of earlier generation drug therapies, including multiple recent failed cardiovascular studies of omega-3 mixture products that contain the omega-3 acid DHA, REDUCE-IT topline results stand alone as positive and confirm our hypothesis that pure EPA Vascepa at 4 grams/day can provide additional cardiovascular risk reduction benefit on top of LDL-C control with standard of care statin therapy in studied patients.
Shares of Amarin trading at $9.98 Monday morning, up more than 233% on the day, with a consensus analyst price target of $7.60 and a 52-week trading range of $2.35 to $4.60.
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