Core Viewpoint - Johnson & Johnson (JNJ) has submitted a new drug application (NDA) to the FDA for icotrokinra, an investigational oral peptide aimed at treating moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 and above [1][9]. Group 1: Clinical Development and Efficacy - The NDA submission is based on data from four phase III studies, part of the ICONIC clinical development program, which evaluated icotrokinra as an IL-23 inhibitor for psoriasis and psoriatic arthritis [2]. - Icotrokinra met all primary and co-primary endpoints across the four pivotal studies, demonstrating significant skin clearance and a favorable safety profile with once-daily oral dosing [3]. - The studies also showed icotrokinra's superiority over Bristol Myers' psoriasis drug, Sotyktu (deucravacitinib) [4][12]. Group 2: Market Position and Future Potential - JNJ's shares have increased by 13.7% this year, contrasting with a 2.1% decline in the industry [5]. - Management believes icotrokinra has the potential to transform the treatment landscape for plaque psoriasis and could establish itself as the new standard of care [6]. - Icotrokinra is designed to block the IL-23 receptor, a key driver of inflammation in plaque psoriasis, with potential applications in other IL-23-driven diseases [7]. Group 3: Collaborative Development and Ongoing Studies - Icotrokinra is being developed in collaboration with Protagonist Therapeutics (PTGX), with JNJ holding exclusive worldwide rights for development beyond phase II studies [10]. - Positive results were reported from the phase IIb ANTHEM-UC study, which evaluated icotrokinra in ulcerative colitis, meeting its primary endpoint [11]. - JNJ is conducting the phase III ICONIC-ASCEND study to compare icotrokinra with its own drug, Stelara (ustekinumab), aiming to provide a more convenient oral alternative [12].

Core Insights - TREMFYA® (guselkumab) demonstrated significant efficacy in inhibiting joint structural damage and improving symptoms in patients with active psoriatic arthritis (PsA) in the Phase 3b APEX study [1][2][3] Efficacy Results - TREMFYA® showed a 2.5 times greater ability to inhibit joint structural damage compared to placebo [1] - At Week 24, 67% of patients receiving TREMFYA® every four weeks (Q4W) and 63% every eight weeks (Q8W) experienced no radiographic progression, compared to 53% in the placebo group [2] - More than 40% of TREMFYA®-treated patients achieved ACR50 response at Week 24, significantly higher than the 20% in the placebo group [1][5] Safety Profile - The safety profile of TREMFYA® remained consistent with previous studies, with no new safety signals identified [3] - TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved for treating PsA, targeting IL-23 and binding to CD64 [3][9] Study Design - The APEX study was a multicenter, randomized, double-blind, placebo-controlled trial involving biologic-naïve patients with active PsA who had inadequate responses to standard therapies [7] Market Position - Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®, which is approved in multiple regions for treating moderate-to-severe plaque psoriasis and active PsA [10][24]

Core Insights - Johnson & Johnson announced significant results from the Phase 3 ASTRO study, demonstrating that TREMFYA® (guselkumab) subcutaneous induction therapy leads to substantial clinical remission and endoscopic improvement in adults with moderately to severely active ulcerative colitis at Week 24 [1][2] Group 1: Study Findings - At Week 24, patients receiving TREMFYA® 400 mg SC induction followed by maintenance doses of 100 mg every eight weeks or 200 mg every four weeks showed statistically significant improvements in clinical remission (35.3% and 36.4% respectively) compared to placebo (9.4%) [2] - Symptomatic remission rates were 54.7% for the 100 mg q8w group and 50.0% for the 200 mg q4w group, compared to 25.2% for placebo [2] - Endoscopic improvement was observed in 40.3% of the 100 mg q8w group and 45.0% of the 200 mg q4w group, while only 12.2% of placebo patients experienced improvement [2] Group 2: Treatment Options and Flexibility - TREMFYA® is the first and only IL-23 inhibitor to show robust results with a fully subcutaneous regimen, providing greater flexibility for physicians and patients in treatment approaches [1][2] - The availability of both subcutaneous and intravenous induction options allows for a more tailored treatment plan for patients with ulcerative colitis [2] Group 3: Safety and Efficacy - Safety data from the ASTRO study were consistent with the established safety profile of TREMFYA®, indicating a favorable risk-benefit ratio [2] - The study included a diverse patient population, demonstrating significant results across various subpopulations, including those who were biologic and JAK inhibitor-naïve or refractory [2] Group 4: Regulatory Approvals - TREMFYA® received FDA approval in September 2024 for treating adults with moderately to severely active ulcerative colitis, with a supplemental Biologics License Application submitted for the SC induction regimen [2] - The drug was also approved for both SC and IV induction options for Crohn's disease in March 2025, expanding its therapeutic applications [2]