Innovative Medicine

Nipocalimab, a first-in-class FcRn blocker being investigated for SjD, met its primary endpoint in the Phase 2 DAHLIAS study with statistically significant improvement in ClinESSDAI score, which is based on 11 key systemic disease domains, at Week 24 versus placebo Critical patient-reported SjD symptoms including dryness, pain and fatigue trended towards greater improvement in the nipocalimab-treated group compared to placebo-treated patients Nipocalimab is the only investigational treatment to be granted Breakthrough Therapy Designation (BTD) by U.S. FDA for the treatment of adults living with moderate-to-severe SjD, and the Phase 3 DAFFODIL study is currently enrolling patients

In areas of high impact, 72% of patients with scalp psoriasis and 85% with genital psoriasis treated with icotrokinra achieved site-specific clear or almost clear skin at Week 52 in Phase 3 ICONIC-TOTAL study 67% of patients treated with icotrokinra achieved overall rates of clear or almost clear skin by Week 24, which was maintained through Week 52 Icotrokinra continues to show potential with its standout combination of exceptional skin clearance and favorable safety profile in a once daily pill

Phase 2b SunRISe-4 study shows 38% of patients treated with INLEXZO™-based combination had no detectable cancer in the bladder prior to surgery Data support potential role of INLEXZO™ in treating muscle invasive bladder cancer

Responses were rapid and durable, and tumor shrinkage was observed in 82 percent of patients New findings from this investigational study build on the strength of RYBREVANT® (amivantamab-vmjw) in non-small cell lung cancer and broadens its potential across additional solid tumors

First Phase 3 study (MajesTEC-3) of an investigational combination to show benefit in PFS and OS in relapsed/refractory multiple myeloma as early as second line Independent Data Monitoring Committee (IDMC) recommended unblinding the study based on statistically significant results

First report of subcutaneous amivantamab demonstrates compelling clinical activity in recurrent or metastatic head and neck cancer, building on strength in colorectal cancer and EGFR-mutated lung cancer New analysis and recent U.S. FDA Fast Track designation underscore promise of first-in-class pasritamig for prostate cancer

17 abstracts from across the Company’s portfolio and pipeline highlight new clinical and real-world data on major depressive disorder and treatment-resistant depression New post-hoc analysis of CAPLYTA® (lumateperone) Phase 3 data evaluates the impact on sexual function in MDD, reinforcing potential to reset treatment expectations European Union and United Kingdom sub-group analyses of Phase 3 data evaluate efficacy of adjunctive seltorexant compared to adjunctive quetiapine XR in MDD with insomnia symptoms New data from post-hoc analysis of ESCAPE-TRD explores association of patient characteristics and remission with SPRAVATO® (esketamine) versus quetiapine XR in treatment-resistant depression

Approval expands SIMPONI® indication to treat children weighing at least 15 kg with moderately to severely active ulcerative colitis SIMPONI® is the only approved treatment to offer a monthly maintenance dose for this patient population