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GSK plcBullish
GSK has received US FDA approval for its chronic hepatitis B treatment, Hibsago (bepirovirsen). The drug demonstrated a 19% functional cure rate in phase III trials, significantly outperforming the current standard of care, and will now be available as a new therapeutic option in the US market.…more
GSK plc
GSK's Jemperli has received accelerated approval from the US FDA as the first and only immunotherapy for adult patients with MSI-H/dMMR locally advanced rectal cancer. This approval is based on data from the phase II AZUR-1 trial, offering a new treatment approach that may help patients avoid chemotherapy, radiation, and surgery.…more
GSK plc
GSK announced positive global phase Ib data for its B7-H3-targeted ADC, Ris-Rez, in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC). The 8 mg/kg dose cohort achieved a 61% objective response rate (ORR) with a manageable safety profile. These findings support the acceleration of the ongoing global phase III EMBOLD SCLC-301 trial.…more
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GSK Wins FDA Approval For Chronic Hepatitis B Drug Hibsago
GSK's chronic hepatitis B treatment, Hibsago, received FDA approval after demonstrating significant functional cure rates in Phase 3 trials. However, the drug includes boxed warnings for serious side effects, which may impact its market adoption.…more
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HUTCHMED has closed an exclusive licensing agreement with GSK for its KRAS-EGFR inhibitor outside of China. The deal includes an upfront payment of $110 million and potential milestone payments reaching up to $1.185 billion.…more
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The FDA has approved Hibsago as the first treatment for adult patients with chronic hepatitis B without cirrhosis. This approval provides a new therapeutic option for the condition and is expected to strengthen the company's market position.…more
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