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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April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.