Johnson & Johnson’s Nipocalimab Wins in 228-Patient Phase IIb, Files OTTAVA Robot for FDA Review
Johnson & Johnson’s Phase IIb JASMINE study of nipocalimab in systemic lupus erythematosus met primary and secondary endpoints in 228 patients, clearing the way for Phase III advancement. The company filed its OTTAVA Robotic Surgical System for FDA De Novo classification based on IDE trial data in upper-abdominal surgery.
1. Nipocalimab Demonstrates Positive Phase IIb JASMINE Results in SLE
Johnson & Johnson’s investigational FcRn blocker nipocalimab achieved its primary and key secondary endpoints in the Phase IIb JASMINE study for systemic lupus erythematosus (SLE). In the randomized, placebo-controlled trial of 228 patients, the treatment arm showed a statistically significant reduction in SLE Disease Activity Index scores at Week 24 versus placebo, with 62% of nipocalimab-treated subjects achieving a clinically meaningful response compared to 31% in the control group. The safety profile was generally consistent with prior studies, with no new signals observed. These data support J&J’s plan to initiate global Phase III trials in SLE in the second half of 2026.
2. OTTAVA Robotic Surgical System Submitted to FDA for De Novo Classification
Johnson & Johnson has filed a De Novo classification application for its OTTAVA™ Robotic Surgical System with the U.S. Food and Drug Administration, leveraging data from its Investigational Device Exemption study. The first 20 soft-tissue upper abdominal procedures were completed in early 2025 at Memorial Hermann-Texas Medical Center by lead investigator Dr. Erik Wilson. Trial results demonstrated successful completion rates in gastric bypass, small bowel resection and hiatal hernia repair, with no device-related serious adverse events. J&J expects FDA feedback in mid-2026 and is preparing a follow-on IDE study in inguinal hernia repair that received approval in late 2025.
3. Asset Management One Increases Holdings in Johnson & Johnson
Asset Management One Co. Ltd. raised its stake in Johnson & Johnson by 3.9% in the third quarter, adding 47,524 shares to reach a total of 1,256,031 shares. This position represents approximately 0.7% of the firm’s portfolio, making J&J its 19th largest holding. The disclosed value of the stake was $232.9 million at the end of the period. Other institutional moves include Brighton Jones LLC boosting its position by 13.9%, and United Bank more than doubling its stake.
4. Multiple Myeloma Combination Seeks EMA Approval Based on MajesTEC-3 Data
J&J has submitted a Type II variation application to the European Medicines Agency to extend the indication for teclistamab (TECVAYLI®) in combination with daratumumab SC for relapsed/refractory multiple myeloma after one prior therapy. The Phase III MajesTEC-3 study enrolled 587 patients and reported an 83.4% reduction in risk of progression or death (HR 0.17; 95% CI 0.12–0.23; P<0.0001) versus standard regimens at nearly three years of follow-up. Safety was comparable across arms, with Grade 3/4 cytopenias and infections as the most common events. An FDA supplemental BLA is under review, with Breakthrough Therapy Designation granted.