JNJ Johnson & Johnson

amivantamab · NCT04538664 registry update

completion: 2027-08-02 → 2027-12-31

teclistamab · NCT06948084 registry update

countries: {'total_sites': 29, 'us_sites': 29} → {'total_sites': 31, 'us_sites': 31}

teclistamab · NCT07605416 registry update

countries: {'total_sites': 10, 'us_sites': 10} → {'total_sites': 11, 'us_sites': 11}

JNJ RYBREVANT FASPRO shows 77% ORR in 1L HNSCC at ESMO 2026

Johnson & Johnson reported Phase 1b/2 OrigAMI-4 Cohort 5 data showing a 77% confirmed ORR (14% CR) with subcutaneous amivantamab plus pembrolizumab and carboplatin in first-line non-HPV-associated recurrent/metastatic HNSCC. Responses were deep, rapid (median 9.4 weeks) and durable (65% ongoing at 10.6 months median follow-up). These results support the ongoing Phase 3 OrigAMI-5 study.

JNJ reports 75% ORR for JNJ-6143 in Phase 1 mCRPC

Johnson & Johnson reported positive Phase 1 results for its first-in-class oral RIPTAC molecule JNJ-6143 in heavily pretreated patients with advanced prostate cancer. The 50 mg once-daily dose showed 75% confirmed ORR in patients with measurable disease and deep PSA reductions, supporting advancement into Phase 2 (NCT07832292).

teclistamab · NCT06948084 registry update

countries: {'total_sites': 27, 'us_sites': 27} → {'total_sites': 29, 'us_sites': 29}

apalutamide · NCT03412396 registry update

completion: 2026-03-30 → 2028-03-30

J&J reports TREMFYA 48-week fistula remission data from Phase 3 FUZION study at UEG Week

Johnson & Johnson presented 48-week results from the Phase 3 FUZION study showing TREMFYA maintained or improved combined fistula remission (35% at Week 48 vs 28% at Week 24 for 100 mg q8w) in adults with Crohn's disease and perianal fistula. The data reinforce prior Week 24 findings versus placebo and were presented at the 2026 United European Gastroenterology Week.

guselkumab · NCT07511647 registry update

status: RECRUITING → ACTIVE_NOT_RECRUITING

teclistamab · NCT06948084 registry update

countries: {'total_sites': 24, 'us_sites': 24} → {'total_sites': 26, 'us_sites': 26}

teclistamab · NCT06948084 registry update

countries: {'total_sites': 23, 'us_sites': 23} → {'total_sites': 24, 'us_sites': 24}

guselkumab · NCT07577843 registry update

countries: {'total_sites': 142, 'us_sites': 20} → {'total_sites': 252, 'us_sites': 22}

teclistamab · NCT07463807 registry update

countries: {'total_sites': 1, 'us_sites': 1} → {'total_sites': 2, 'us_sites': 2}

JNJ: FDA approves IMAAVY (nipocalimab) for warm autoimmune hemolytic anemia

FDA approved IMAAVY (nipocalimab-aahu) as the first-ever treatment for warm autoimmune hemolytic anemia (wAIHA). This is the first approved therapy for the indication and represents a landmark regulatory milestone for the asset.

JNJ TREMFYA (guselkumab) shows consistent perianal fistula remission in Crohn's subgroups at ACG 2026

New prespecified analyses from the Phase 3 FUZION study demonstrated consistent combined fistula remission rates with TREMFYA versus placebo across difficult-to-treat subgroups including prior biologic exposure, proctitis, and higher luminal disease activity. These data, presented at ACG 2026, build on the primary Week 24 results where TREMFYA achieved up to 28% remission versus 10% for placebo.

Johnson & Johnson presents 2-year ICOTYDE (icotrokinra) Phase 3 data at Fall Clinical Dermatology 2026

Johnson & Johnson presented new two-year Phase 3 ICONIC-LEAD results for ICOTYDE (icotrokinra) at the Fall Clinical Dermatology conference. The data show sustained high rates of skin clearance (PASI 90 ≥72%, IGA 0/1 ≥70%) and symptom improvement through Week 112 with a consistent safety profile in adults and adolescents with plaque psoriasis.

teclistamab · NCT05932680 registry update

primary_completion: 2026-06 → 2027-01; completion: 2027-01 → 2027-05

Johnson & Johnson presents 2-year ICOTYDE data at EADV 2026 in high-impact plaque psoriasis

Johnson & Johnson presented new two-year Phase 3 ICONIC-TOTAL data for ICOTYDE (icotrokinra) at the EADV Congress 2026, showing sustained skin clearance in difficult-to-treat sites including scalp, genital, hands/feet and nails with a consistent safety profile. These long-term results support its use as a first-line systemic therapy for moderate-to-severe plaque psoriasis.

SpyGlass Pharma Acquires AVS from Santen to Secure IOL Manufacturing for BIM-IOL System

SpyGlass Pharma acquired 100% of Advanced Vision Science, Inc. (AVS), its current IOL manufacturer and a former Santen subsidiary, for ~$13M. The deal secures scalable commercial manufacturing capacity for the Phase 3 BIM-IOL System and accelerates development of premium lens options (toric, EDOF) integrated with its drug-delivery platform. AVS will continue supplying Santen in Japan and licensing material to Bausch + Lomb and others.

apalutamide · NCT05534646 registry update

primary_completion: 2027-01 → 2028-01; completion: 2027-01 → 2028-01; enrollment: 100 → 116; primary_outcomes: ['Progression free survival (rPFS) between patients receiving apalutamide and apalutamide + carotuximab'] → ['Progression free survival (rPFS) between patients receiving AR blockade and AR blockade + carotuximab']

J&J to present 15 IMAAVY (nipocalimab) abstracts including 2-year Vibrance-MG data at AANEM/MGFA 2026

Johnson & Johnson announced new two-year data from the Vibrance-MG Phase 2/3 long-term extension in adolescents with anti-AChR+ gMG showing sustained improvements in MG-ADL and QMG scores through Week 108 plus corticosteroid reductions. A retrospective HCP survey on treatment transitions in adults was also highlighted. The data will be presented at the MGFA Scientific Session during AANEM 2026.

teclistamab · NCT06948084 registry update

countries: {'total_sites': 14, 'us_sites': 14} → {'total_sites': 17, 'us_sites': 17}

Johnson & Johnson CARVYKTI® shows 50% 5-year treatment-free remission in early line multiple myeloma

New long-term follow-up data from the Phase 2 CARTITUDE-2 study show that 50% of patients with early line relapsed or refractory multiple myeloma achieved five-year treatment-free remissions after a single infusion of CARVYKTI® (ciltacabtagene autoleucel). These results suggest earlier treatment may increase the likelihood of long-term remission and reinforce the potential curative approach of CARVYKTI®.

icotrokinra · NCT07196748 registry update

countries: {'total_sites': 401, 'us_sites': 55} → {'total_sites': 402, 'us_sites': 56}

teclistamab · NCT07605416 registry update

countries: {'total_sites': 2, 'us_sites': 2} → {'total_sites': 7, 'us_sites': 7}

JNJ presents MajesTEC-3 model-based analyses at IMS showing potential long-term survival benefit of TECVAYLI + DARZALEX FASPRO

New model-based and post-hoc analyses from the ongoing Phase 3 MajesTEC-3 trial were presented at the International Myeloma Society Annual Meeting. The data project that ~87% of patients treated with the combination as early as second-line may achieve mortality risk comparable to the general population, driven by a 90% reduction in disease progression risk.

JNJ: FDA approves IMAAVY (nipocalimab-aahu) for wAIHA

FDA granted full approval for IMAAVY as the first therapy specifically indicated for warm autoimmune hemolytic anemia in adults and adolescents 12 years and older. The approval was based on the Phase 2/3 ENERGY trial showing durable hemoglobin response and fatigue improvement versus placebo. This converts the asset from an investigational FcRn blocker to an approved, marketed product for wAIHA.

SpyGlass: Phase 3 BIM-IOL enrollment on track for 2027 completion

The 8-K confirms that the two parallel registrational Phase 3 trials of the BIM-IOL System remain on track, with enrollment completion now guided for 2027. The company also states that the first-in-human trial of the next-generation BIM-DRS is expected to start in the second half of 2026. No new regulatory filings or agency decisions are reported.

Johnson & Johnson receives FDA De Novo authorization for OTTAVA robotic system

FDA granted De Novo marketing authorization for the OTTAVA Robotic Surgical System, allowing commercial use in ten specified general surgery procedures. The system is the first table-integrated soft tissue robotic platform cleared in the U.S. J&J will begin a limited U.S. commercial launch while continuing trials for additional indications.

Johnson & Johnson: FDA approves Dual Energy THERMOCOOL SMARTTOUCH SF Platform

FDA approved the Dual Energy THERMOCOOL SMARTTOUCH SF Platform, allowing delivery of both radiofrequency and pulsed-field energy through a single catheter. The platform integrates with the CARTO ecosystem and is indicated for atrial fibrillation ablation. First U.S. procedures are expected to begin this summer following a phased commercial rollout.