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TheFly reported on May 27 that GILD presented long-term interim findings from the ongoing Phase 3 ***** URE study of Livdelzi at the 2026 European ***** ociation for the Study of the Liver Congress in Barcelona. A post hoc ***** ysis showed sustained improvement in liver function markers among patients with primary biliary cholangitis who had persistently elevated alkaline phosphatase despite prior first-line therapy.
Across treated participants, ALP levels declined, and a high proportion achieved biochemical normalization over extended follow-up, with durable responses observed up to two years. Additional ***** yses indicated stability in other indicators of cholestasis and liver stiffness over time. The safety profile remained consistent with earlier findings, with no treatment discontinuations due to adverse events and no new safety concerns identified.
In an interconnected pipeline development, Gilead Sciences, Inc. (NASDAQ:GILD) announced on May 22 that the European Medicines Agency’s CHMP issued a positive opinion recommending marketing authorization for Trodelvy (sacituzumab govitecan-hziy) as a first-line monotherapy option for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who are not eligible for PD-1 or PD-L1 inhibitor therapy.
The decision is based on Phase 3 ASCENT-03 results demonstrating statistically significant and clinically meaningful improvement in progression-free survival compared with standard chemotherapy, including a 38% reduction in the risk of disease progression or death. Metastatic TNBC remains a highly aggressive cancer with limited first-line options and poor outcomes. The recommendation now proceeds to the European Commission for final review, with a decision expected later in 2026.
TheFly reported on May 27 that GILD presented long-term interim findings from the ongoing Phase 3 ***** URE study of Livdelzi at the 2026 European ***** ociation for the Study of the Liver Congress in Barcelona. A post hoc ***** ysis showed sustained improvement in liver function markers among patients with primary biliary cholangitis who had persistently elevated alkaline phosphatase despite prior first-line therapy.
Across treated participants, ALP levels declined, and a high proportion achieved biochemical normalization over extended follow-up, with durable responses observed up to two years. Additional ***** yses indicated stability in other indicators of cholestasis and liver stiffness over time. The safety profile remained consistent with earlier findings, with no treatment discontinuations due to adverse events and no new safety concerns identified.
In an interconnected pipeline development, Gilead Sciences, Inc. (NASDAQ:GILD) announced on May 22 that the European Medicines Agency’s CHMP issued a positive opinion recommending marketing authorization for Trodelvy (sacituzumab govitecan-hziy) as a first-line monotherapy option for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who are not eligible for PD-1 or PD-L1 inhibitor therapy.
The decision is based on Phase 3 ASCENT-03 results demonstrating statistically significant and clinically meaningful improvement in progression-free survival compared with standard chemotherapy, including a 38% reduction in the risk of disease progression or death. Metastatic TNBC remains a highly aggressive cancer with limited first-line options and poor outcomes. The recommendation now proceeds to the European Commission for final review, with a decision expected later in 2026.
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