The FDA on Friday approved Amarin's Vascepa (AMRN) for an expanded label for cardiovascular risk reduction in elevated triglyceride patients.
"We now have further clarity on the breakdown of labeling, which we interpret positively in terms of our expectations," H.C. Wainwright analyst Andrew Fein tells investors in a research note. He believes that the characterization of triglyceride levels at 150mg/dL or higher did not come as a surprise, despite incorporation of patients with triglyceride levels as low as 135mg/dL in the REDUCE-IT trial.
The analyst continues to think physicians can utilize their best judgment in assessing whether to assign the proven benefits of Vascepa in cardiovascular risk reduction when evaluating at-risk patients. Fein points out that his omega-3 proprietary physician survey indicated broad physician support for utilizing Vascepa with an expanded label in CV risk reduction.
He reiterates a Buy rating on Amarin shares with a $51 price target. Fein maintains his current Vascepa sales revenue estimates of $416M in 2019 and $663M in 2020.
The stock in premarket trading is up 11% to $26.75.
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