GSK (GSK) Gains FDA Approval for Hibsago, Enhancing Dividend App

GSK's Hibsago (bepirovirsen) received FDA approval for chronic hepatitis B in adults without cirrhosis. The approval is based on Phase 3 trial results showing a 19% functional cure rate. GSK licensed the drug from Ionis and is pursuing regulatory submissions globally. GSK's stock closed at $50.63, up 2.37%.

GSK's Hibsago (bepirovirsen), licensed from Ionis, received FDA approval for treating chronic hepatitis B (CHB). The drug, showing 19% functional cure rates in trials, is used with NrtI therapy. Ionis may receive milestone payments and royalties. GSK is pursuing regulatory approvals globally. Bepirovirsen has Breakthrough Therapy and Priority Review designations in the U.S., China, and Japan.

GSK's bepirovirsen (HIBSAGO) received FDA approval for chronic hepatitis B (CHB) treatment, showing 19% functional cure rates in trials. The six-month treatment can be administered at home after the first dose. GSK licensed the drug from Ionis in 2019, with Ionis eligible for milestone payments and royalties. CHB affects approximately 1.7 million people in the U.S.

Hutchmed (00013.HK) finalized a licensing deal with GSK for its KRAS-EGFR conjugate therapy, HMPL-A830. GSK gains global rights (excluding Greater China) for $110M upfront, with up to $1.185B in milestones. Hutchmed leads Phase I trials, while GSK handles later stages. The drug targets cancers with KRAS mutations, currently in early clinical testing.

GSK's depemokimab (Exdensur) showed significant improvements in asthma patients' quality of life, with benefits seen as early as 4 weeks and persisting through 52 weeks, according to a study presented at the CHEST Annual Meeting. The treatment was administered subcutaneously twice a year, with 363 patients receiving 100 mg doses and 196 on placebo. Mean changes in symptom, activity, and impact scores on the St.

HUTCHMED (HCM) has finalized a deal with GSK, granting GSK rights to develop and commercialize HMPL-A830, an ATTC drug candidate for cancer, outside Mainland China. HUTCHMED expects to receive $110 million from the agreement. The drug targets KRAS-altered tumors, common in colorectal, pancreatic, and lung cancers. HUTCHMED will lead global Phase I development, while GSK handles subsequent clinical trials and commercialization in its territory.