Following recent U.S. FDA approval of TREMFYA® for adults with moderately to severely active ulcerative colitis (UC), this submission underscores its potential to be the only IL-23 inhibitor that offers choice of subcutaneous or intravenous induction in UC Submission is supported by the Phase 3 ASTRO study, which achieved the primary endpoint of clinical remission at Week 12 and met all secondary endpoints in adults with moderately to severely active UC

More than 90 presentations of clinical trial and real-world data highlight potentially practice-changing evidence and commitment to pioneer the next wave of therapies for patients with hematologic malignancies

Icotrokinra (JNJ-2113), a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, met its co-primary endpoints in patients with moderate to severe plaque psoriasis 74% of patients achieved clear or almost clear skin (IGA 0/1) at week 24 Comprehensive results are being prepared for presentation at upcoming medical congresses

The amivantamab plus lazertinib combination regimen offers potential to provide new standard of care as first-line option for adult patients with advanced NSCLC with EGFR ex19del or L858R substitution mutations1 In the Phase 3 MARIPOSA study, amivantamab plus lazertinib significantly reduced risk of disease progression or death by 30 percent versus osimertinib monotherapy1

Adults with moderately-to-severely active Sjögren’s disease who received investigational FcRn blocker nipocalimab had improvements in disease activity scores at 24 weeks with accompanying significant reductions in IgG and autoantibody levels Nipocalimab was granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren’s disease based on results from the Phase 2 DAHLIAS study

New collaboration to strengthen and deliver advanced soft tissue repair solutions for shoulder, foot and ankle procedures

Company prepares to support clinical trial in the United States

The Breakthrough Therapy Designation (BTD) for investigational nipocalimab in Sjögren’s disease, a prevalent autoantibody disease with no approved advanced therapies, is supported by results from the Phase 2 DAHLIAS study A greater than 70 percent relative improvement in systemic disease activity at Week 24 was demonstrated in study participants on average who received nipocalimab 15 mg/kg compared to participants who received placebo Nipocalimab was granted BTD in hemolytic disease of the fetus and newborn earlier this year, making this the second time Johnson & Johnson’s nipocalimab has received this designation

If approved, DARZALEX FASPRO® will become the first treatment option for patients with smoldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset of active disease and the occurrence of end organ damage