“Later this year, we expect to provide an update from our Phase III IDEAL study evaluating Libdelzi in patients with ALP levels between 1 and 1.67 times the upper limit of normal.”

In context

“GS-3242 and GS-1219 as well as GS-1614 and islatrovir prodrug. Consistent with the timeline shared during our HIV analyst event in December 2024, we have identified GS-3242 as the most promising program with lenacapavir and prioritized its development as a potential twice-yearly HIV treatment. As a result, and as a reminder, we have discontinued the development of a twice-yearly regimen with GS-1219, and a quarterly regimen with GS-1614. Turning to liver disease on slide 20. We remain committed to further evaluating Libdelzi to potentially improve the standard of care for more patients with PBC. At the liver meeting in November, we presented late-breaking real-world data showing that Libdelzi is an effective and well-tolerated alternative for PBC patients switching from obeticholic acid. Later this year, we expect to provide an update from our Phase III IDEAL study evaluating Libdelzi in patients with ALP levels between 1 and 1.67 times the upper limit of normal. Patients typically excluded from Phase III studies. If positive, these data could support the expansion of Libdelzi to incomplete responders to UDCA and potentially enable even more second-line PBC patients to achieve better biochemical and symptomatic control of their PBC. Moving to oncology on Slide 21. Trodelvy has demonstrated clinically meaningful survival benefit in two Phase III trials establishing it as a leading regimen in its approved indications. Most recently, Trodelvy has demonstrated highly statistically significant and clinically meaningful progression-free survival benefit across first-line metastatic triple-negative breast cancer patients. Full data from the Phase III ASCENT-03 and ASCENT-04 trials were published in the New England Journal of Medicine in October 2025 and”