Amarin: Rises as FDA panel unanimously votes to expand heart drug label

Grace Therapeutics

15/11/2019 14:26

(Updates)
    ** Shares of drugmaker  AMRN.O  up 4.5% at $22.46 premarket
    ** FDA panel voted 16-0 on Thursday to expand label of co's
heart drug capsules, Vascepa, as an additional therapy for
patients on statins with high risk of heart attacks or strokes
with previous history of the diseases  urn:newsml:reuters.com:*:nL4N27U4Y0
    ** Vascepa was previously approved in 2012 by the FDA for
patients with high levels of triglycerides; the new expanded
approval potentially opens up a multi-billion opportunity for
Vascepa 
    ** FDA expected to take final decision by Dec. 28; it
typically follows the advice of its expert panels but is not
mandated to do so  urn:newsml:reuters.com:*:nGNX3pcLRd
    ** Shares were halted on Thursday as the FDA panel was
discussing co's label extension application  urn:newsml:reuters.com:*:nGNX9cwdL3
   ** Shares of Acasti  ACST.O  and Matinas  MTNB.N , which are
also developing omega-3 fatty acid-based drugs to lower
triglycerides, also rise; ACST up 7.7% and MTNB up 16.7%
    ** Up to Wednesday's close, AMRN stock had risen 57.9% YTD;
ACST had more than doubled and MTNB had risen ~49% in the same
period

 (Reporting by Ruhi Soni)
 ((Ruhi.Soni@thomsonreuters.com;))