FDA expected to make decision on Amarin's AMR101 this week

theflyonthewall.com

The FDA is scheduled to make an announcement regarding the status of Amarin's (AMRN) AMR101, a treatment for patients with very high triglyceride levels, on July 26. The time allotted for the agency to review the drug is due to expire on that day. A prescription-grade omega-3 fatty acid, AMR101 has significantly reduced the "bad" cholesterol of patients who take the drug in trials, compared with those who take placebos. On May 29, Amarin announced that it had received a patent covering the pharmaceutical composition of AMR101. Last month the USPTO took positive action on three key Amarin patent applications, leading research firm Jefferies to predict that AMR101 could be protected through 2030. Meanwhile, in a note to investors earlier this morning, JPMorgan said there's a strong likelihood that AMR101 will be approved by the FDA on July 26. Any delay in approval of the drug would be minor, said the firm, which thinks the drug could generate $1B+ in sales. JPMorgan believes that the stock could advance further following FDA approval, and the firm maintains a $22 target and Overweight rating on Amarin. In early trading, Amarin rose 0.46% to $15.23.

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