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.
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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