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GSK PLC - London-based pharmaceuticals maker - Bepirovirsen, GSK’s treatment for chronic hepatitis B, is accepted for priority review and given ’breakthrough therapy designation’ by the US Food & Drug Administration. GSK says the fast track approval process for its new drug application recognises bepirovirsen’s potential for substantial improvement over existing treatments. Chronic hepatitis is a leading cause of liver cancer, and bepirovirsen, an investigational antisense oligonucleotide, showed ‘clinically meaningful functional cure rates’ in phase III trials of adults. The FDA sets October 26 as its goal date for a decision on the drug application. GSK on Monday had announced two positive regulatory rulings for efimosfermin, a once-monthly investigational liver therapy. Efimosfermin also was granted breakthrough therapy designation by the FDA. In addition, it was given a ’priority medicines designation’ by the European Medicines Agency for the treatment of metabolic dysfunction-associated steatohepatitis. Current stock price: 2,007.00 pence 12-month change: up 42% Copyright 2026 Alliance News Ltd. All Rights Reserved.
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