London, Jan 7, 2026, 07:52 GMT — Premarket
GSK (GSK.L) said on Wednesday its experimental chronic hepatitis B drug bepirovirsen met the primary endpoint in two phase III studies, putting it on track for regulatory submissions. The drugmaker said global filings are planned from the first quarter of 2026 after the B-Well 1 and B-Well 2 trials enrolled more than 1,800 patients across 29 countries. Chief Scientific Officer Tony Wood called the readout a “major advance”, and GSK said it defines a functional cure as losing a key viral protein and having no detectable virus DNA for at least 24 weeks after treatment ends. GSK
The result hands new CEO Luke Miels an early pipeline win after he took over from Emma Walmsley at the start of the year. Investors are counting on new launches to help GSK hit more than 40 billion pounds in annual revenue by 2031; bepirovirsen is expected to deliver more than 2 billion pounds in peak sales, while analysts currently estimate 2031 sales at about 35 billion pounds. Reuters
That matters because most approved hepatitis B medicines suppress the virus but rarely deliver a finite course that leaves patients off treatment. A clear late-stage signal can shift expectations quickly for a drugmaker whose valuation leans heavily on whether its next wave of products can scale.
GSK shares ended Tuesday up 4.3% at 19.00 pounds, outpacing a 1.2% rise in the FTSE 100, and trading volume was below the 50-day average. The stock is still about 8% below its 52-week high of 20.58 pounds, leaving the 20-pound area in view as investors gauge whether the latest pipeline news can extend the run. MarketWatch
In a separate stock exchange filing on Wednesday, GSK said the European Commission approved a prefilled syringe presentation for Shingrix, its shingles vaccine. The company said the new format removes preparation steps for healthcare workers and will begin rolling out across EU countries in 2026 without changing dosing, with Wood saying it aims to improve “ease of administration”. TradingView
A day earlier, GSK said Japan’s health ministry approved Exdensur, its depemokimab, for severe asthma and chronic rhinosinusitis with nasal polyps, giving the company a twice-yearly option in the market for biologic respiratory drugs. Kaivan Khavandi, GSK’s global head of respiratory, immunology and inflammation R&D, said the approval “could set a new standard of care”, and GSK said the decision follows approvals in the United States and Britain. GSK
But investors still need full phase III detail on durability and side effects to judge how quickly a hepatitis B therapy could translate into sales. Regulators can demand more follow-up, and uptake will hinge on how payers price a finite course against years of chronic antiviral treatment.
