GSK plc (GSK,GSK.L) announced that the European Medicines Agency has accepted for review the marketing authorisation application for the use of bepirovirsen, an investigational antisense oligonucleotide, in the treatment of adults with chronic hepatitis B. The regulatory submission to EMA is based on positive results from the B-Well 1 and B-Well 2 Phase III trials.
GSK licensed bepirovirsen from Ionis Pharmaceuticals and collaborated with them on its development. It is currently not approved anywhere in the world.
At last close, shares of GSK were trading at 2,047.00 pence.
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Business News
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