CLAIM #27434 · GILD (GILD) · 2026Q1 earnings call · May 7, 2026 · due Jun 30, 2026
“We expect an FDA regulatory decision for bulevirtide as a treatment for chronic HDV infection later this quarter.”
Dietmar Berger · Chief Medical Officer
In context
“e targeting Phase 3 registrational trials in select autoimmune diseases as early as 2027. Longer term, we believe gembritomig has potential in more than 20 autoimmune diseases that are driven by pathogenic B and plasma cells. Additionally, this year we plan to share updates from our broader inflammation portfolio, including the Phase 3 IDEAL study evaluating Libdelzi in PBC patients with incomplete response to UDCA, the Phase 2 SWIFT study evaluating GS-1427 or envistigraf, our investigational oral alpha4beta7 inhibitor for inflammatory bowel diseases, and the Phase 2a COSMIC study evaluating usertib, our investigational IRAK4 kinase inhibitor, in cutaneous lupus erythematosus. Finally, reviewing our 2026 pipeline milestones on slide 20, we remain on track across all our key deliverables. We expect an FDA regulatory decision for bulevirtide as a treatment for chronic HDV infection later this quarter. Bulevirtide has been approved as Hepcludex in the EU since 2020, and we look forward to making this available to patients in the U.S. Additionally, we expect FDA regulatory decisions for Biclen in August and anitocel in December, as well as Phase 3 updates for ILLAND-1 and -2 in the first half of this year, and for EVOQUE-3, ASCENT GYN, and IDEAL in the second half. With that, I would like to thank our research and development teams and our partners, whose continued strong clinical execution are driving the progress we have seen across our pipeline. Now I will turn over the call to Andy. Andrew Dickinson: Thank you, Dietmar. Good afternoon, everyone. As you have heard, Gilead Sciences, Inc. delivered strong first quarter results with continued commercial outperformance and disciplined ope”
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SEC filings for GILD ↗ · Claim quote is verbatim from the 2026Q1 earnings call.