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SPRING HOUSE, Pa. - Johnson & Johnson (NYSE: JNJ) has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for nipocalimab, intended for the treatment of adult patients with moderate-to-severe Sjögren’s disease (SjD). This autoimmune disease currently lacks FDA-approved advanced treatments. The Fast Track status follows the Breakthrough Therapy designation granted to nipocalimab for SjD in late 2024, highlighting the FDA’s support for rapid development and review of the drug due to the serious nature of the condition and the lack of adequate treatments.
Sjögren’s disease affects millions worldwide and can lead to systemic complications, including joint pain, fatigue, and an increased risk of mortality. Patients with SjD are also at a heightened risk of developing B-cell lymphomas. The investigational therapy nipocalimab, an FcRn blocker, has shown promise in the Phase 2 DAHLIAS study, achieving its primary endpoint with significant improvement in systemic disease activity and IgG reductions compared to placebo.
Nipocalimab’s mechanism involves blocking FcRn to reduce circulating immunoglobulin G (IgG) antibodies, which include autoantibodies associated with various autoimmune diseases. The FDA has previously granted nipocalimab several designations for different conditions, emphasizing its potential across a spectrum of autoantibody-related disorders.
Johnson & Johnson, through its companies Janssen Research & Development, LLC, and Janssen Biotech, Inc., continues to advance the clinical development of nipocalimab. The Phase 3 DAFFODIL study is currently enrolling patients to further evaluate the drug’s efficacy and safety.
This announcement is based on a press release statement and reflects ongoing efforts by Johnson & Johnson to address unmet medical needs in autoantibody diseases. The company’s commitment to healthcare innovation aims to provide new treatment options for conditions with significant impact on patients’ lives.
In other recent news, Johnson & Johnson reported positive outcomes from its Phase 2b ANTHEM-UC clinical trial for icotrokinra, showing significant improvements in ulcerative colitis patients. The trial met its primary endpoint with a 63.5% clinical response rate at the highest dose, compared to 27% for the placebo group. Additionally, Johnson & Johnson has successfully completed a multi-billion euro notes offering, raising capital expected to be used for general corporate purposes, including potential acquisitions. Meanwhile, RBC Capital Markets has maintained its Outperform rating on Johnson & Johnson, citing the promising sales potential of icotrokinra, which could exceed $5 billion annually. In contrast, Johnson & Johnson has opted out of a licensing deal with Genmab for HexaBody-CD38, despite initial promising data. Furthermore, Johnson & Johnson announced the discontinuation of its Phase 3 VENTURA program testing aticaprant for major depressive disorder due to insufficient efficacy. This development influenced Guggenheim Securities to downgrade Neumora Therapeutics to Neutral, as Neumora faced similar challenges with its own trials. These recent developments highlight Johnson & Johnson’s strategic focus on advancing its pharmaceutical division and managing its financial resources.
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