Amarin plunges as FDA denies appeal on ANCHOR trial SPA

14 September 2014

Shares of US biotech firm Amarin Corp (Nasdaq: AMRN) tanked 23.7% to $1.38 on Friday in heavy trading, when the company revealed that the US Food and Drug Administration’s Office of New Drugs (OND) had denied its appeal of the FDA's rescission of the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement relating to Vascepa (icosapent ethyl).

Amarin had previously expressed that, while it believes strongly in its legal, scientific and regulatory appeal arguments that it would be an uphill battle to achieve an SPA agreement reinstatement. Amarin continues to believe that reinstatement of this SPA agreement and approval of an indication based on the ANCHOR clinical trial results is in the best interest of patient care and is evaluating OND's response and potential next steps. Amarin has not yet received a determination from the FDA on the pending ANCHOR supplemental new drug application (sNDA).

Retains current approval status

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