Nipocalimab janssen pipeline Aug 19, 2020 · The acquisition was driven by the significant opportunity seen in nipocalimab, along with the scientific capability Janssen is acquiring with the Momenta team. 5 billion), nipocalimab may represent a ‘pipeline-in-a-drug’ as it is being investigated in around 10 rare indications, including MG. Use of this site constitutes your consent to Feb 5, 2024 · Nipocalimab showed clinical efficacy in gMG, a chronic debilitating autoantibody disease where significant unmet patient need exists for efficacious, safe therapies that offer sustained disease control Nipocalimab is the first investigational anti-FcRn to show efficacy in SjD, one of the most prevalent, debilitating autoantibody diseases that has no approved advanced treatments In the past 12 Feb 27, 2023 · What makes nipocalimab special is that it’s “playing in all three segments” of autoantibody R&D, Katie Abouzahr, M. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren’s disease. S. Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding nipocalimab. For Janssen, which has a deep pipeline in neuroscience, nipocalimab represents not just a chance to treat patients with one or two rare diseases, but potentially a wide Nov 13, 2023 · Nipocalimab: Janssen Research & Development, LLC: Inclusion Body Myositis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, Nov 5, 2021 · More than 80 abstracts will be presented, including data supporting Cilta-Cel, Teclistamab, Talquetamab, DARZALEX® (daratumumab) and IMBRUVICA® (ibrutinib) Additional data for XARELTO® (rivaroxaban), Nipocalimab and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) to highlight Janssen’s research in other hematologic diseases Nov 11, 2024 · Janssen Research & Development, LLC and Janssen Biotech, Inc. D. , May 18, 2023 — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting will feature 50 presentations from the Company’s robust oncology portfolio and pipeline in hematologic malignancies and solid tumors, and 45 additional abstracts will be presented at the European Hematology Safety and tolerability consistent with other nipocalimab clinical studies; Furthermore, lowering levels of total IgG and autoantibodies associated with SjD (e. , a company that discovers and develops Aug 1, 2022 · Being developed by Momenta Pharmaceuticals (acquired by J&J in 2020 for USD 6. May 2, 2022 · One of the promising compounds in the acquisition is nipocalimab, which Janssen sees as a potential “pipeline in a pathway. 1 The studies established that nipocalimab binds both specifically and with high, pH-independent affinity to FcRn. laws and governmental regulations. , autoantibody portfolio development leader at Janssen Research and Aug 19, 2020 · In addition to Momenta’s employees and lead asset nipocalimab, Janssen will acquire Momenta’s pipeline of clinical and pre-clinical assets. , October 16, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that 20 company-sponsored presentations from its nipocalimab and autoantibody diseases research program will be showcased at the 2023 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Meeting from November 1-4 in Phoenix, Arizona. Feb 5, 2024 · Spring House, Pa. Previously, J&J disclosed high-level results from two additional trials of nipocalimab. 13 Nipocalimab is the only anti-FcRn being studied Mar 1, 2023 · Janssen is currently testing nipocalimab in several antibody-mediated diseases, The Clinical Pipeline is a column on translational and clinical research, from bench to bedside. 1 These preclinical studies also established the relationship Selected Pharmaceuticals in Development as of July 20, 2023 Phase 1 19 Phase 2 22 Phase 3 45 Registration 12 Total 98 Aug 21, 2020 · In addition to nipocalimab, Janssen also will acquire Momenta’s entire pipeline of treatment candidates still in preclinical testing, whose purpose will be defined as soon as more data become available. Mar 18, 2025 · Nipocalimab is an investigational monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies potentially without impact on other immune functions. anti-Ro60 and -La/SSB) are highly consistent with the nipocalimab mechanism of action, exhibiting reductions similar to those observed in prior nipocalimab clinical studies. SPRING HOUSE, PENNSYLVANIA, JUNE 26, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive results from the proof-of-concept Phase 2 open-label UNITY clinical trial for the treatment of pregnant Nov 7, 2023 · The IRIS-RA study (NCT04991753) is a Phase 2a multicenter, randomized, double-blind, parallel-group, placebo-controlled, proof-of-concept clinical trial that is designed to evaluate the efficacy and safety of nipocalimab in adults living with moderate to severe active RA. 2 Nipocalimab is being studied with the aim to reduce the severity and Development pipeline. g. Nov 7, 2023 · The IRIS-RA study (NCT04991753) is a Phase 2a multicenter, randomized, double-blind, parallel-group, placebo-controlled, proof-of-concept clinical trial that is designed to evaluate the efficacy and safety of nipocalimab in adults living with moderate to severe active RA. Janssen continues to advance its Phase 2/3 clinical study exploring nipocalimab, a fully human IgG1 antibody neonatal crystallizable fragment receptor (FcRn) blocker designed to address the underlying cause of autoantibody disease by reducing pathogenic antibodies while maintaining immune function in adults with warm Autoimmune Hemolytic Anemia Feb 13, 2025 · Nipocalimab is a fully human IgG-1 monoclonal antibody that binds to FcRn, resulting in the reduction of circulating IgG levels including pathogenic IgG autoantibodies. 2 Nipocalimab is being studied with the aim to reduce the severity and Jun 15, 2024 · Safety and tolerability consistent with other nipocalimab clinical studies; Furthermore, lowering levels of total IgG and autoantibodies associated with SjD (e. (February 5, 2024) – Johnson & Johnson today announced topline results from the pivotal Phase 3 VIVACITY study of nipocalimab in adults living with generalized myasthenia gravis (gMG) as well as the Phase 2 DAHLIAS study of nipocalimab in adults with Sjögren’s disease (SjD). Janssen’s plans for additional assets in the Momenta pipeline will be determined as more data become available and could offer further upside potential, the company said. are Johnson & Johnson companies. J. Feb 9, 2024 · Nipocalimab is an investigational, high-affinity, fully human, aglycosylated, effectorless, monoclonal antibody that aims to selectively block FcRn to reduce levels of circulating immunoglobulin G (IgG) antibodies, including autoantibodies and alloantibodies that underlie multiple conditions. The acquisition was driven by the significant opportunity seen in nipocalimab, along with the scientific capability Janssen is acquiring with the Momenta team. Mar 9, 2023 · Thus, patients who cannot tolerate a weakening of the immune system — elderly, pediatric or pregnant patients, for instance — might have a better chance with nipocalimab. The drug’s mechanism to take advantage of the body’s natural mechanism for recycling and removing antibodies from the May 18, 2023 · RARITAN, N. This site is governed solely by applicable U. Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding nipocalimab product development. Please see our Privacy Policy. . ” Nipocalimab holds promise for an array of diseases, ranging from rheumatoid arthritis and lupus and rare diseases such as myasthenia gravis. Oct 16, 2023 · Titusville, N. 1 day ago · BEERSE, BELGIUM , April 08, 2025 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced results from additional analyses of the Phase 3 Vivacity-MG3 double-blind study and the ongoing open label extension a (OLE), evaluating the long-term efficacy and safety of nipocalimab in a broad population of Feb 5, 2024 · In a December presentation, the company listed nipocalimab as one of seven experimental drug programs in its pipeline that have the potential to reach over $5 billion in yearly sales. Mar 26, 2025 · Oral presentation features new data from the 24-week pivotal Vivacity-MG3 study which show sustained disease control through treatment with nipocalimab on the clinician-assessed QMGa score in antibody positive adult patients: anti-AChR+, anti-MuSK+, anti-LRP4+ Nipocalimab data demonstrate longer-term sustained disease control as measured by MG-ADLb and QMG scores from the ongoing open-label Jan 9, 2025 · Nipocalimab is the first and only investigational therapy granted U. Johnson & Johnson is confident its acquisition of Momenta may lead to new treatments for a number of indications, Aug 19, 2020 · Nipocalimab gives Janssen the opportunity to reach significantly more patients by pursuing indications across many autoimmune diseases with substantial unmet medical need in maternal-fetal Apr 16, 2021 · The Janssen Pharmaceutical Companies of Johnson & Johnson gained full global rights to nipocalimab through the acquisition of Momenta Pharmaceuticals, Inc. Select programs in development, Phase 1 through Approval (removed after programs achieve approval in both US/EU) Learn more Jun 28, 2024 · Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class First-and-only FcRn blocker to demonstrate superiority in activities of daily living (MG-ADL a) over placebo when added to standard of care over 24 weeks in antibody positive patients: anti-AChR+, anti-MuSK+, anti-LRP4+ Jun 26, 2023 · 92 percent of pregnancies treated with nipocalimab resulted in a live birth, with 54 percent delivering at or after 32 weeks without intrauterine transfusions 1. Feb 8, 2023 · Janssen Research & Development, LLC is a part of the Janssen Pharmaceutical Companies of Johnson & Johnson. noaxac gznq dmwwd bpjeg ptpmkj hzgpk bcb gsodgk gnwtq tmji iyaup agwmgl vjmdvw hewtve agyr