GSK plc (GSK,GSK.L) announced the FDA has accepted for priority review a New Drug Application for bepirovirsen, an investigational antisense oligonucleotide, for the treatment of adults with chronic hepatitis B. The FDA has assigned 26 October 2026 as the PDUFA goal date. Bepirovirsen has also received Breakthrough Therapy Designation. The Group said the regulatory submission and BTD are supported by positive results from the Phase III B-Well 1 and B-Well 2 trials.
GSK licensed bepirovirsen from Ionis Pharmaceuticals and collaborated with them on its development. Bepirovirsen is currently not approved anywhere in the world.
At last close, shares of GSK plc were trading at 2,012.00 pence, down 0.20%.
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Business News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.