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Innovative Medicine

Johnson & Johnson enters new era in solid tumors at ESMO 2025 with promising data across multiple cancer types

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

Johnson & Johnson to highlight breadth of its major depressive disorder portfolio at 2025 ECNP Congress

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

U.S. FDA approves SIMPONI® (golimumab) for the treatment of pediatric ulcerative colitis

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

TREMFYA® (guselkumab) is first and only IL-23 inhibitor to demonstrate sustained clinical and endoscopic outcomes with a fully subcutaneous regimen through 48 weeks in ulcerative colitis

Patients treated with subcutaneous TREMFYA® achieved clinically meaningful results in both clinical remission (36.7%) and endoscopic remission (25.9%) at Week 48 in the Phase 3 ASTRO study Clinical and endoscopic outcomes were demonstrated across both biologic-naïve and biologic-refractory sub-groups TREMFYA® is the only IL-23 inhibitor with a fully subcutaneous regimen, following recent FDA approval of SC induction in adults with ulcerative colitis

Icotrokinra data in ulcerative colitis show potential for a standout combination of therapeutic benefit and a favorable safety profile in once-daily pill

Icotrokinra met the primary endpoint of clinical response at all three doses, with 36.5% of patients treated with the highest dose achieving endoscopic improvement at Week 12 in the Phase 2b ANTHEM-UC study These data support the promise of a first-in-class targeted oral peptide that selectively blocks the IL-23 receptor as a potential new option for people with moderately to severely active ulcerative colitis

U.S. FDA approves TREMFYA® (guselkumab) for the treatment of pediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor

TREMFYA® is now approved for pediatric patients living with moderate to severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, and active psoriatic arthritis in children six years and older, weighing at least 40 kg Approval was based on PROTOSTAR study, which showed pediatric patients receiving TREMFYA® achieved high levels of skin clearance vs. placebo at Week 16

Johnson & Johnson’s investigational seltorexant shows numerically higher response in patients with depression with insomnia symptoms, with fewer side effects compared to quetiapine XR

Seltorexant, in combination with an oral antidepressant, demonstrated a numerically greater response rate at week 26 with a more favorable safety and tolerability profile compared to adjunctive quetiapine XR Patients treated with adjunctive seltorexant also saw notably less weight gain, and somnolence rates were four times lower than those in patients treated with adjunctive quetiapine XR

TREMFYA® (guselkumab) achieves U.S. approval for subcutaneous induction in adults with ulcerative colitis, now the first and only IL-23 inhibitor with a fully subcutaneous regimen

TREMFYA® offers the flexibility of self-administration from the start of treatment, building on the prior approval of subcutaneous induction in Crohn’s disease TREMFYA® achieved significant rates of clinical remission and endoscopic improvement versus placebo at Week 12 with a subcutaneous induction regimen, consistent with IV induction Johnson & Johnson is initiating a head-to-head study seeking to demonstrate the superiority of TREMFYA® vs. Skyrizi® (risankizumab) in Crohn’s disease, based on the confidence in the clinical profile