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Fly News Breaks for August 9, 2019
AMRN
Aug 9, 2019 | 07:39 EDT
The FDA's decision to host an Advisory Committee meeting could be driven more by the agency's conservative approach to an expanded cardiovascular event risk reduction label potentially impacting tens of millions of Americans, than any immediate concerns regarding Amarin's REDUCE-IT results themselves, H.C. Wainwright analyst Andrew Fein tells investors in a research note. Management noted the expanded Vascepa label has the potential to be the first indication to impact as many as a third of American adults, and along these lines the FDA holding an AdCom "represents vigilance above all else," contends the analyst. He continues to emphasize that the current stage of commercial development "could potentially represent just the tip of the iceberg for Vascepa." Fein downplays the significance of the AdCom in terms of "materially influencing" the overall approval path for Vascepa's expanded label and reiterates his belief of Vascepa "as a game changing drug." He believes the AdCom timing can be quantifiably valued and is "only worth" approximately a $2-$3 potential hit to his price target of $51. Fein reiterates a Buy rating on Amarin.
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