UPDATE: Amarin (AMRN) Surges; Is It NCE Related?
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(Updated - October 18, 2012 12:41 PM EDT)
Shares of Amarin Corporation plc (NASDAQ: AMRN) are surging higher mid-day Thursday which could be related to chatter about progress in NCE status from the FDA. NCE status designation has been delayed many times and now some believe it won't be granted at all. If granted, it would be a positive surprise, giving FDA-approved drug Vascepa many more years of exclusivity and could move potential suitors closer to a bid.
The hubbub on NCE comes following a September post at US National Library of Medicine National Institutes of Health:
"The FDA considers Vascepa to be a new chemical entity. It contains only EPA but not DHA, and it does not contain any appended portions of both EPA and DHA that cause them to be an ester, salt, or other non-covalent derivative. Therefore, its active moiety has not been previously approved by the FDA in any other application submitted under Section 505(b) of the Federal Food, Drug, and Cosmetic Act.
Shares are up 6.8 percent on heavy volume.
Shares of Amarin Corporation plc (NASDAQ: AMRN) are surging higher mid-day Thursday which could be related to chatter about progress in NCE status from the FDA. NCE status designation has been delayed many times and now some believe it won't be granted at all. If granted, it would be a positive surprise, giving FDA-approved drug Vascepa many more years of exclusivity and could move potential suitors closer to a bid.
The hubbub on NCE comes following a September post at US National Library of Medicine National Institutes of Health:
"The FDA considers Vascepa to be a new chemical entity. It contains only EPA but not DHA, and it does not contain any appended portions of both EPA and DHA that cause them to be an ester, salt, or other non-covalent derivative. Therefore, its active moiety has not been previously approved by the FDA in any other application submitted under Section 505(b) of the Federal Food, Drug, and Cosmetic Act.
Shares are up 6.8 percent on heavy volume.
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