GSK Stock Discussion (GSK plc)

GSK wins US hepatitis B approval, opening a royalty stream for Ionis

The FDA has approved GSK ($GSK)’s Hibsago, or bepirovirsen, alongside nucleos(t)ide analogue treatment for a defined group of adults with chronic hepatitis B without cirrhosis. Eligibility includes at least six months of prior analogue therapy, suppressed viral DNA and a hepatitis B surface-antigen level no higher than 3,000 IU/ml, measured with an authorized test. The new treatment is given as a six-month course. In the pivotal B-Well studies, 19% achieved functional cure, defined by sustained

GSK

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GSK presents Jideytro data supporting a potential first-line lung-cancer filing

GSK ($GSK) reported a 94% response rate for Jideytro in 94 evaluable patients with ROS1-positive advanced lung cancer who had not previously received a ROS1 tyrosine kinase inhibitor. In the single-arm Phase 1/2 ARROS-1 study, 90% were progression-free at twelve months. Seven of ten patients with measurable brain metastases achieved complete clearance of detectable brain tumors. Treatment-related adverse events led to dose reductions in 11% of patients and discontinuation in 1%. GSK plans a US s