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Innovative Medicine

Johnson & Johnson investigational co-antibody therapy JNJ-4804 shows potential to raise the bar for clinical efficacy in treating refractory inflammatory bowel disease

JNJ-4804 demonstrated highest rates of clinical and endoscopic outcomes compared to golimumab and guselkumab in patients with ulcerative colitis or Crohn’s disease who have had inadequate response to two or more systemic therapy classes JNJ-4804 is the first and only fixed dose co-antibody designed to deliver molecular synergy in IBD by blocking the complementary IL-23 and TNF pathways Data from Phase 2b DUET studies show potential to address a critical unmet need and support advancement to Phase 3 trials

Johnson & Johnson study shows TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to demonstrate efficacy in perianal fistulizing Crohn’s disease

TREMFYA® demonstrated significantly higher rates of combined fistula remission – complete external closure of draining fistulas and absence of fluid collection on MRI – compared to placebo at Week 24 First study of its kind in 20 years for this debilitating manifestation of Crohn’s disease presented as late-breaking data at Digestive Disease Week (DDW) 2026

CAPLYTA® (lumateperone) showed greatest improvement across key efficacy outcomes among adjunctive MDD treatments in new network meta-analysis

CAPLYTA® ranked highest among FDA-approved adjunctive therapies across four measures of efficacy, based on indirect comparisons from placebo plus antidepressant therapy-controlled trials Among the secondary endpoints for the adjunctive MDD therapies evaluated, CAPLYTA® demonstrated no weight gain compared to placebo plus antidepressant therapy Featured in a late-breaking presentation at the 2026 NEI Spring Congress, analysis provides indirect comparisons to help inform treatment decisions in the absence of head-to-head clinical trials

Johnson & Johnson ushers in the next wave of innovation in cancer care with more than 20 clinical and real-world studies at ASCO 2026

· Late-breaking Phase 3 PROTEUS data for ERLEADA® (apalutamide) selected to open the ASCO plenary, signaling a potential paradigm shift for high-risk prostate cancer in patients receiving curative-intent surgical treatment · Results from MajesTEC-9, the second positive Phase 3 study of TECVAYLI® (teclistamab-cqyv), reinforce TECVAYLI® regimens as potential new standard of care in multiple myeloma as early as second line · Pivotal OrigAMI-4 results evaluating RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) reinforce its potential to redefine treatment in advanced head and neck cancer

FDA grants Priority Review for IMAAVY® (nipocalimab-aahu) as the potential first approved treatment for people living with warm autoimmune hemolytic anemia (wAIHA)

Priority Review is granted to medicines that may offer significant improvements in safety or effectiveness for serious conditions like warm autoimmune hemolytic anemia, a life-threatening disease in which pathogenic immunoglobulin G autoantibodies attach to and destroy red blood cells, leading to debilitating anemia IMAAVY is designed to target the underlying cause of warm autoimmune hemolytic anemia by reducing circulating immunoglobulin G, including autoantibodies, while preserving critical immune functions Pivotal study showed rapid and durable hemoglobin responsea and fatigue improvementb compared to placebo in patients with warm autoimmune hemolytic anemia

FDA approves CAPLYTA® (lumateperone) sNDA with robust new data supporting reduced risk of relapse in schizophrenia

CAPLYTA® reduced relapse risk by 63 percent, with 84 percent of patients with schizophrenia relapse-free over six months Demonstrating long-term stability and a well-established safety profile consistent with previous CAPLYTA® studies

IMAAVY® (nipocalimab-aahu) shows over two years of sustained disease control in a broad population with generalized myasthenia gravis (gMG)

Through 120 weeks of follow-up, IMAAVY delivered sustained clinical improvements and reductions in total IgG in antibody-positive adult patients including anti-AChR+ and anti-MuSK+ Patients achieving sustained minimal symptom expression (MSE) experienced greater improvements in quality of life than those with transient MSE in a post-hoc analysis of the Phase 3 study EPIC, the first head-to-head study of IMAAVY versus another FcRn blocker in generalized myasthenia gravis, is now enrolling participants