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Aegis Capital Corp. Reiterates on Amarin Corporation plc After FDA Formally Rescinds Special Protocol Assessment


In a report published Wednesday, Aegis Capital Corp. analyst Raghuram Selvaraju reiterated a Hold rating on Amarin Corporation plc (NASDAQ: AMRN).

In the report, Aegis Capital Corp. noted, “Yesterday, Amarin disclosed via 8-K filing that the FDA had notified it of the formal rescinding of the original Special Protocol Assessment (SPA) that had been given to the company prior to the completion of the ANCHOR study of Amarin's lead drug Vascepa™ in the treatment of mixed dyslipidemia. In our view, this move could probably have been predicted, since with the formal SPA rescindment the agency may be trying to protect itself from any legal recourse that Amarin might pursue (although SPAs are not the same as contractual promises in any case). Investors will recall that the FDA held an Advisory Committee meeting on October 16, 2013, at which the panel voted 9-2 against recommending approval of Vascepa™ in mixed dyslipidemia ahead of the release of data from the REDUCE-IT outcomes trial. It now appears a given that Amarin will not be able to obtain an expanded label for Vascepa™ from the FDA without positive data from this trial. As stated previously, we continue to expect the firm to receive a Complete Response Letter (CRL) from the FDA on the sNDA for Vascepa™ in mixed dyslipidemia. Although Amarin recently announced a broad-based restructuring of the organization in order to reduce costs, and expects to lower the annualized cash burn to roughly $80mm, we continue to be skeptical of Amarin's chances of obtaining approval for Vascepa™ in mixed dyslipidemia and maintain our Hold rating without a price target on Amarin shares.”

Amarin Corporation plc closed on Tuesday at $2.10.

Latest Ratings for AMRN

Feb 2021SVB LeerinkMaintainsOutperform
Sep 2020SVB LeerinkMaintainsOutperform
Aug 2020Piper SandlerInitiates Coverage OnOverweight

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Posted-In: Aegis Capital Corp. Raghuram SelvarajuAnalyst Color Reiteration Analyst Ratings

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