“We are targeting Phase 3 registrational trials in select autoimmune diseases as early as 2027.”

In context

“t to develop in collaboration with Galapagos. Together with Kite's portfolio of anitocel and next-generation bias-tuned CAR Ts, we believe we could achieve durable immune reset, shifting some autoimmune diseases from chronic symptom control to a transformative long-term treatment effect. Each asset offers unique potential advantages that could allow us to target different patient populations. Specifically, gembritomig has shown rapid, deep, and sustained plasma and B cell depletion while maintaining low rates and low-grade CRS with no ICANS to date in over 60 patients with immune-mediated diseases. We are focusing first on orphan autoimmune indications with established proof of concept and high unmet need, including autoimmune cytopenias, pemphigus, and idiopathic inflammatory myopathies. We are 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 infec”