GSK PLC (LSE:GSK, NYSE:GSK) said on Wednesday that a potential new treatment for chronic hepatitis B had delivered positive late-stage trial results, raising the prospect of a shorter, more effective therapy for a disease that affects more than 250 million people worldwide. The drug, bepirovirsen, met its primary goal in two large phase III trials, B-Well 1 and B-Well 2, with GSK saying it achieved a “statistically significant and clinically meaningful” functional cure rate when added to existing treatment.
GSK's experimental drug to treat chronic hepatitis B infection met the main goals in two closely watched studies, the drugmaker said on Wednesday, bringing the company a step closer to making a functional cure available to patients.
GSK PLC (LSE:GSK, NYSE:GSK) said Japan has approved Exdensur (depemokimab) to treat severe or refractory bronchial asthma and chronic rhinosinusitis with nasal polyps. The big-cap drugmaker said the authorisation was based on phase III SWIFT and ANCHOR trial data evaluating twice-yearly dosing versus placebo, each on top of standard of care.
GSK PLC (LSE:GSK, NYSE:GSK) has become the latest big pharma company to fall into line with the US government's "most favoured nation" drug pricing regime, in exchange for an exemption from tariffs. The FTSE 100 group said the voluntary agreement with the White House implements all four policy actions requested by President Trump earlier this year.
South Korea's Samsung Biologics said on Monday its U.S. unit is buying a U.S. drug production facility from GSK for $280 million.
The companies, including Bristol-Myers Squibb, GSK and Merck, would avoid potential U.S. tariffs in return.
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GSK has surged ~46% YTD, far outpacing both the healthcare sector and S&P 500, which is notable considering the spectre of high US tariffs hanging over it. The recent US-UK pharmaceuticals deal, the company's investment plans in the US, and the likelihood of a possible drug pricing agreement with the US government can work for GSK. Supporting these developments is the company's solid financial performance, upgraded outlook and attractive market multiples.
GSK secures FDA approval for Exdensur, the first twice-yearly biologic for treating severe asthma with an eosinophilic phenotype.
The U.S. Food and Drug Administration has approved GSK's add-on drug to treat asthma and a chronic inflammatory sinus condition, the drugmaker said on Tuesday, paving the way for a less frequently dosed treatment option for patients to enter the market.
UK's health regulator on Monday approved GSK's twice-yearly drug for use as an add-on treatment for asthma in patients aged 12 and older, as well as for a chronic inflammatory sinus condition in adults.
GSK gets CHMP backing for Nucala in COPD and depemokimab in asthma, setting up possible Europe approvals in 2026 for IL-5 therapies.