FDA Decision Due on GSK's Bepirovirsen for Chronic Hepatitis B
SCHEDULEDDate confidence: SCHEDULEDGiven as scheduledHow firmly the source words the date: confirmed, scheduled, estimated, delayed or unverified.Show all SCHEDULED pins75% CONFIDENCEOverall confidence: 75%How well the pin's source and references back up its dates.Weighted average of how firmly 3 references, the source included, support the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins at 75% confidence or betterGSK's[1][2] release states "October 26, 2026 assigned by FDA as PDUFA date" and its later release says a US decision is "expected from the FDA by 26 October 2026".
The FDA has set 26 October 2026 as its priority-review goal date for GSK's bepirovirsen, an antisense drug aimed at a functional cure of chronic hepatitis B after two positive phase III B-Well trials.
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