LONDON - Johnson & Johnson (NYSE:JNJ) announced today that nipocalimab met the primary endpoint of decreasing disease activity at 24 weeks in adults with moderate-to-severe systemic lupus erythematosus in its Phase 2 JASMINE study, according to a press release statement.
The study measured disease activity using the SLE Responder Index 4 (SRI-4), with 53.5% of patients receiving nipocalimab 15 mg/kg plus background medication achieving an SRI-4 response at Week 24, compared with 46.7% for placebo plus background medication. At Week 52, 53.6% of patients receiving nipocalimab 15 mg/kg achieved an SRI-4 response, compared with 39.7% for placebo.
In autoantibody-positive patients, representing approximately 80% of people with SLE, greater SRI-4 response rates were observed at Week 52, with 58.2% versus 36.1% for placebo plus background medication.The positive trial results come as InvestingPro analysis suggests JNJ is currently undervalued, with shares trading below Fair Value. For investors seeking deeper insights, a comprehensive Pro Research Report is available, offering expert analysis on JNJ’s pipeline and financial health.
The study enrolled 228 adult participants aged 18-65 years with moderate-to-severe SLE who had not responded to at least one standard-of-care treatment. Participants received intravenous nipocalimab at 5 or 15 mg/kg, or placebo every two weeks through Week 52.
Nipocalimab is designed to selectively block the neonatal Fc receptor, reducing levels of circulating pathogenic immunoglobulin G autoantibodies and immune complexes associated with inflammation in SLE. The most common adverse reactions in patients treated with nipocalimab were nasopharyngitis, headache, urinary tract infection and nausea.
The drug received Fast Track Designation in SLE by the U.S. Food and Drug Administration in January 2026. The ongoing Phase 3 GARDENIA study is currently recruiting. Nipocalimab is not FDA-approved for SLE.
The findings were presented at the European Alliance of Associations for Rheumatology 2026 Congress in London.
In other recent news, Johnson & Johnson reported significant findings from its Phase 3 PROTEUS study, revealing that apalutamide combined with hormone therapy reduced the risk of metastasis or death by 20% in prostate cancer patients. The trial, which included 2,109 participants, showed that this combination extended the time before subsequent therapy was needed to over six years. Additionally, Johnson & Johnson’s subsidiary Abiomed won a jury trial in Massachusetts, as it was found that Abiomed’s Impella heart pumps did not infringe on Maquet Cardiovascular’s patent rights, with the jury also declaring the patent invalid.
The U.S. Food and Drug Administration approved an updated label for Johnson & Johnson’s Tremfya, highlighting its effectiveness in inhibiting joint damage progression in psoriatic arthritis patients. This decision was based on results from the Phase 3b APEX study. In another development, DePuy Synthes, a part of Johnson & Johnson, secured an exclusive distribution agreement with CGBIO for the NOVOSIS bone graft substitute, which will be distributed in the U.S., Canada, and Australia.
Johnson & Johnson also launched the Shockwave C2 Aero Coronary IVL Catheter for treating calcified coronary artery disease. This next-generation catheter offers improved deliverability and enhanced lesion crossing capabilities. These recent developments reflect Johnson & Johnson’s ongoing efforts in advancing medical treatments and technologies across various healthcare areas.
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