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Last update 23 Apr 2025

Nipocalimab

Last update 23 Apr 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

anti-FcRn monoclonal antibody(Momenta Pharmaceuticals), Immunoglobulin g1, anti-(human neonatal fc receptor) (human monoclonal m281 .gamma.-1 chain), disulfide with human monoclonal m281 .lambda.-chain, dimer, Nipocalimab (USAN)

+ [4]

Target

FcRn

Action

antagonists, modulators

Mechanism

FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Immunomodulators

Therapeutic Areas

NeoplasmsImmune System DiseasesNervous System Diseases+ [7]

Active Indication

Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingMyasthenia GravisSjogren's Syndrome+ [11]

Inactive Indication-

Originator Organization

Momenta Pharmaceuticals, Inc.

Active Organization

Johnson & Johnson (China) Investment Ltd.Janssen Research & Development LLC

Vetter Pharma-Fertigung GmbH & Co. KG

+ [1]

Inactive Organization

Momenta Pharmaceuticals, Inc.

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationFast Track (United States), Orphan Drug (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Priority Review (United States), Breakthrough Therapy (United States), Orphan Drug (Japan)

Structure/Sequence

Sequence Code 19395495L

Source: *****

Sequence Code 19395504H

Source: *****

Clinical Trials associated with Nipocalimab

NCT04883619

/ Not yet recruitingPhase 2

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN).

Start Date15 Jan 2026

Sponsor / Collaborator

Janssen Research & Development LLC

ISRCTN14534389

/ RecruitingPhase 2

A randomized, placebo-controlled, double-blind, multicenter phase 3 protocol to assess the efficacy and safety of nipocalimab in adults with moderate to severe Sjogren's disease (SjD)

Start Date05 May 2025

Sponsor / Collaborator

Janssen Research & Development LLC

NCT06533098

/ RecruitingPhase 3

Multicenter, Open-Label, Randomized Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

The purpose of this study is to assess the efficacy and safety of nipocalimab in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).

Start Date10 Feb 2025

Sponsor / Collaborator

Janssen Research & Development LLC

100 Clinical Results associated with Nipocalimab

100 Translational Medicine associated with Nipocalimab

100 Patents (Medical) associated with Nipocalimab

Literatures (Medical) associated with Nipocalimab

31 Dec 2025·mAbs

Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties

Article

Author: Sukumaran, Siddharth ; Xu, Rui ; Abouzahr, Katie ; Ling, Leona E. ; Avery, William ; Roy, Sucharita ; Beavers, Traymon ; Choudhury, Amit ; Sihapong, Samuel ; Price, Karen ; Kumar, Sujatha ; Narayanaswami, Pushpa ; DuPrie, Matthew ; Markowitz, Lynn ; Bhattacharya, Sayak ; Brown, Julia ; Daly, Thomas ; Tyler, Steven ; Seth, Nilufer P. ; Rutitzky, Laura ; Cochran, Edward ; Meador, James ; Hubbard, Jonathan J. ; Pao, Yvonne ; Elwood, Fiona ; Duffner, Jay ; Parge, Viraj ; Wang, Yang ; Chen, Hsin

Nipocalimab is a human immunoglobulin G (IgG)1 monoclonal antibody that binds to the neonatal Fc receptor (FcRn) with high specificity and high affinity at both neutral (extracellular) and acidic (intracellular) pH, resulting in the reduction of circulating IgG levels, including those of pathogenic IgG antibodies. Here, we present the molecular, cellular, and nonclinical characteristics of nipocalimab that support the reported clinical pharmacology and potential clinical application in IgG-driven, autoantibody- and alloantibody-mediated diseases. The crystal structure of the nipocalimab antigen binding fragment (Fab)/FcRn complex reveals its binding to a unique epitope on the IgG binding site of FcRn that supports the observed pH-independent high-binding affinity to FcRn. Cell-based and in vivo studies demonstrate concentration/dose- and time-dependent FcRn occupancy and IgG reduction. Nipocalimab selectively reduces circulating IgG levels without detectable effects on other adaptive and innate immune functions. In vitro experiments and in vivo studies in mice and cynomolgus monkeys generated data that align with observations from clinical studies of nipocalimab in IgG autoantibody- and alloantibody-mediated diseases.

31 Dec 2025·Human Vaccines & Immunotherapeutics

A randomized, open-label study on the effect of nipocalimab on vaccine responses in healthy participants

Article

Author: Jackson, Amanda ; Scott, Brittney ; Beier, Ulf H. ; Myshkin, Eugene ; Lam, Edwin ; Liu, Grace ; Dimitrova, Dessislava ; Weisel, Kathleen ; Cossu, Marta ; Bobadilla Mendez, Carolina ; Gao, Sheng ; Leu, Jocelyn H.

Nipocalimab, a human immunoglobulin G (IgG) 1 monoclonal antibody, selectively binds the IgG-binding site on the neonatal Fc receptor (FcRn) and blocks IgG recycling, reducing IgG levels without impacting antigen presentation or T-/B-cell functions. In this phase 1, open-label study, we assessed the effect of nipocalimab on IgG response in healthy adults receiving T-cell-dependent/-independent vaccines (ie, tetanus toxoid [TT], diphtheria, and acellular pertussis vaccine [Tdap] and 23-polysaccharide pneumococcal vaccine [PPSV®23], respectively). Participants received either no drug (control) or intravenous nipocalimab (30 mg/kg at Week 0; 15 mg/kg at Weeks 2 and 4). All participants received Tdap and PPSV®23 vaccinations on Day 3 and were followed through Week 16. Twenty-nine participants completed the study (active, n=15; control, n=14). All participants mounted a response to Tdap vaccination, with 3 (20%) participants in the active arm and 7 (50%) participants in the control arm achieving a positive anti-TT response at Week 4 (primary endpoint; p=.089). Nipocalimab treatment was associated with numerically lower anti-TT and anti-pneumococcal (PCP)-specific IgG responses at Week 4 but comparable responses at Weeks 2 and 16. Overall, anti-TT IgG levels remained above the protective threshold (0.16 IU/mL) for all participants, and anti-PCP IgG levels remained above the 50 mg/L threshold and showed a 2-fold increase from baseline in both arms. Nipocalimab coadministration with Tdap and PPSV®23 was safe and well tolerated. Results suggest that nipocalimab does not impact the development of IgG responses to T-cell-dependent/-independent vaccines and participants treated with nipocalimab can follow recommended vaccination schedules.Trial registration number: NCT05827874.

01 Feb 2025·LANCET NEUROLOGY

Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study

Article

Author: Bril, Vera ; De Bleecker, Jan ; Youssef, Eriene ; Grudniak, Mariusz ; Sun, Hong ; Sevilla, Teresa ; Sheehan, John J ; Ramchandren, Sindhu ; Zhu, Yaowei ; Sanga, Panna ; Karcher, Keith ; Farmakidis, Constantine ; Sivakumar, Kumaraswamy ; Yang, Huan ; Minks, Eduard ; Smilowski, Marek ; Hoffmann, Sarah ; Vu, Tuan ; Antozzi, Carlo ; Park, Jin-Sung ; Suzuki, Yasushi ; Nowak, Richard J

BACKGROUND:

Given burdensome side-effects and long latency for efficacy with conventional agents, there is a continued need for generalised myasthenia gravis treatments that are safe and provide consistently sustained, long-term disease control. Nipocalimab, a neonatal Fc receptor blocker, was associated with dose-dependent reductions in total IgG and anti-acetylcholine receptor (AChR) antibodies and clinically meaningful improvements in the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale in patients with generalised myasthenia gravis in a phase 2 study. We aimed to assess the safety and efficacy of nipocalimab in a phase 3 study.

METHODS:

Vivacity-MG3 was a phase 3, randomised, double-blind, placebo-controlled, phase 3 study conducted at 81 outpatient centres with expertise in myasthenia gravis in 17 countries in Asia-Pacific, Europe, and North America. Adults (aged ≥18 years) with generalised myasthenia gravis inadequately controlled with standard-of-care therapy (MG-ADL score ≥6) were randomly assigned (1:1) to either nipocalimab (30 mg/kg loading dose then 15 mg/kg every 2 weeks for maintenance dosing) or placebo infusions every 2 weeks, added to standard-of-care therapy in both groups, for 24 weeks. Randomisation was stratified by antibody status, day 1 MG-ADL total score, and region. The sponsor, investigators, clinical raters, and participants were masked to treatment assignment. The primary endpoint was the difference between nipocalimab and placebo based on least-squares mean change from baseline in MG-ADL total score averaged over weeks 22, 23, and 24 in the intention-to-treat population of patients who were antibody-positive (for AChR, anti-muscle-specific tyrosine kinase [MuSK], or anti-low-density lipoprotein receptor-related protein 4 [LRP4]). Adverse events were assessed in patients who received at least one dose of study drug. This study is registered at ClinicalTrials.gov, NCT04951622; the double-blind phase is completed and an open-label extension phase is ongoing.

FINDINGS:

Between July 15, 2021, and Nov 17, 2023, 199 patients were enrolled, and 196 patients received study drug (98 in the nipocalimab group and 98 in the placebo group); of these, 153 (77 in the nipocalimab group and 76 in the placebo group) were antibody-positive. The least-squares mean change in MG-ADL score from baseline to weeks 22, 23, and 24 was -4·70 (SE 0·329) in the nipocalimab group versus -3·25 (0·335) in the placebo group (difference -1·45 [95% CI -2·38 to -0·52]; p=0·0024). The incidence of adverse events was similar between groups (82 [84%] of 98 in both the nipocalimab and placebo groups), including infections (42 [43%] of 98 in the nipocalimab group and placebo group) and headache (14 [14%] of 98 in the nipocalimab group and 17 [17%] of 98 in the placebo group). Serious adverse events were reported for nine (9%) of 98 patients in the nipocalimab group and 14 (14%) of 98 patients in the placebo group, three of which had a fatal outcome (nipocalimab: myasthenic crisis; placebo: cardiac arrest and myocardial infarction).

INTERPRETATION:

Results from the completed double-blind phase of Vivacity-MG3 support the role of nipocalimab, added to standard-of-care therapies, as a safe treatment for sustained disease control over 6 months for a broad population of patients with generalised myasthenia gravis who are antibody-positive. The ongoing open-label extension phase should provide longer term sustained safety and efficacy data with nipocalimab.

FUNDING:

Janssen Research & Development, LLC, a Johnson & Johnson company.

127

News (Medical) associated with Nipocalimab

15 Apr 2025

·www.investor.jnj.com

Johnson & Johnson Reports Q1 2025 Results

2025 First-Quarter reported sales growth of 2.4% to $21.9 Billion with operational growth of 4.2%* and adjusted operational growth of 3.3%* 2025 First-Quarter earnings per share (EPS) increased to $4.54 which includes the reversal of special charges and adjusted EPS increased to $2.77 or 2.2%* Significant new product pipeline progress including approval of TREMFYA in Crohn’s disease, data for RYBREVANT/LAZCLUZE overall survival in non-small cell lung cancer and icotrokinra in plaque psoriasis, and initiation of the clinical trial for a general surgery robotic system, OTTAVA Company increases Full-Year 2025 operational sales2,5 guidance to reflect the addition of CAPLYTA following the completion of the Intra-Cellular Therapies acquisition Including tariff costs, dilution from the Intra-Cellular Therapies acquisition, and updated foreign exchange, Company maintains Full-Year 2025 adjusted reported EPS4 outlook of 6.2%* growth at the mid-point NEW BRUNSWICK, N.J.--(BUSINESS WIRE)-- Johnson & Johnson (NYSE: JNJ) today announced results for first-quarter 2025. “The power of Johnson & Johnson’s uniquely diversified portfolio was on full display this quarter, with strong operational sales growth reinforcing our confidence in 2025 guidance,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “During the quarter, we fortified our position as an innovation powerhouse with major advancements across our pipeline, including TREMFYA in IBD, RYBREVANT plus LAZCLUZE in non-small-cell lung cancer, and OTTAVA, our soft tissue surgical robotic system, and further enhanced our leading neuroscience portfolio with the completion of the Intra-Cellular Therapies acquisition.” Overall financial results Q1 ($ in Millions, expect EPS) 2025 2024 % Change Reported Sales $21,893 $ 21,383 2.4% Net Earnings $10,999 $3,255 237.9% EPS (diluted) $4.54 $1.34 238.8% Q1 Non-GAAP* ($ in Millions, except EPS) 2025 2024 % Change Operational Sales1,2 4.2% Adjusted Operational Sales1,3 3.3% Adjusted Net Earnings1,4 $6,706 $6,580 1.9% Adjusted EPS (diluted)1,4 $2.77 $2.71 2.2% Free Cash Flow6,7 ~$3,400 $2,850 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency 4 Excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine 6 Non-GAAP measure; defined as cash flow from operating activities, less additions to property, plant and equipment. Cash flow from operations, the most directly comparable GAAP financial measure, will be included in subsequent SEC filings. 7 First-quarter 2025 is estimated as of April 15, 2025 Regional sales results Q1 % Change ($ in Millions) 2025 2024 Reported Operational1,2 Currency Adjusted Operational1,3 U.S. $12,305 $11,620 5.9% 5.9 - 4.4 International 9,588 9,763 (1.8) 2.1 (3.9) 1.9 Worldwide $21,893 $21,383 2.4% 4.2 (1.8) 3.3 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency Segment sales results Q1 % Change ($ in Millions) 2025 2024 Reported Operational1,2 Currency Adjusted Operational1,3 Innovative Medicine $13,873 $13,562 2.3% 4.2 (1.9) 4.4 MedTech 8,020 7,821 2.5 4.1 (1.6) 1.3 Worldwide $21,893 $21,383 2.4% 4.2 (1.8) 3.3 1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules 2 Excludes the impact of translational currency 3 Excludes the net impact of acquisitions and divestitures and translational currency First-Quarter 2025 segment commentary: Operational sales* reflected below excludes the impact of translational currency. Innovative Medicine Innovative Medicine worldwide operational sales grew 4.2%* driven primarily by DARZALEX, CARVYKTI, ERLEADA, and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and SIMPONI/SIMPONI ARIA in Immunology, SPRAVATO in Neuroscience, and XARELTO in Cardiovascular/Metabolism/Other. Growth was partially offset by an approximate (810) basis points impact from STELARA in Immunology. MedTech MedTech worldwide operational sales grew 4.1%*, with net acquisitions and divestitures positively impacting growth by 2.8%. Growth was driven primarily by Abiomed in Cardiovascular and wound closure products in General Surgery. Growth was partially offset by Spine, Sports & Other in Orthopaedics. Full-year 2025 guidance: Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson's results computed in accordance with GAAP. ($ in Billions, except EPS) April 2025 January 2025 Adjusted Operational Sales1,2,5 Change vs. Prior Year / Mid-point 2.0% – 3.0% / 2.5% 2.0% – 3.0% / 2.5% Operational Sales2,5 / Mid-point Change vs. Prior Year / Mid-point $91.6B – $92.4B / $92.0B 3.3% – 4.3% / 3.8% $90.9B – $91.7B / $91.3B 2.5% – 3.5% / 3.0% Estimated Reported Sales3,5/ Mid-point Change vs. Prior Year / Mid-point $91.0B – $91.8B / $91.4B 2.6% – 3.6% / 3.1% $89.2B – $90.0B / $89.6B 0.5% – 1.5% / 1.0% Adjusted Operational EPS (Diluted)2,4 / Mid-point Change vs. Prior Year / Mid-point $10.50 – $10.70 / $10.60 5.2% – 7.2% / 6.2% $10.75 – $10.95 / $10.85 7.7% – 9.7% / 8.7% Adjusted EPS (Diluted)3,4 / Mid-point Change vs. Prior Year / Mid-point $10.50 – $10.70 / $10.60 5.2% – 7.2% / 6.2% $10.50 – $10.70 / $10.60 5.2% – 7.2% / 6.2% 1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures 2 Non-GAAP financial measure; excludes the impact of translational currency 3 Calculated using Euro Average Rate: April 2025 = $1.10 and January 2025 = $1.04 (Illustrative purposes only) 4 Non-GAAP financial measure; excludes intangible amortization expense and special items 5 Excludes COVID-19 Vaccine Other modeling considerations will be provided on the webcast. Notable announcements in the quarter: The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at News Releases, as well as Innovative Medicine News Center, MedTech News & Events, and www.factsabouttalc.com. Regulatory European Commission approves subcutaneous RYBREVANT (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer1 Press Release European Commission approves Johnson & Johnson’s subcutaneous DARZALEX (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility1 Press Release U.S. FDA approves TREMFYA (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn's disease Press Release Nipocalimab, the first and only investigational treatment to be granted U.S. FDA Breakthrough Therapy designation for the treatment of adults with moderate-to-severe Sjögren's disease, has now received Fast Track designation Press Release Data Releases Johnson & Johnson MedTech Announces Completion of First Cases with OTTAVA Robotic Surgical System1 Press Release Icotrokinra results show 75% of adolescents with plaque psoriasis achieved completely clear skin and demonstrate favorable safety profile in a once daily pill1 Press Release Johnson & Johnson highlights new data that showcase the strength of nipocalimab, demonstrating long-term sustained disease control in adults living with generalized myasthenia gravis (gMG)1 Press Release TREMFYA (guselkumab) is the first and only IL-23 inhibitor to significantly reduce both the signs and symptoms and the progression of structural damage in adults living with active psoriatic arthritis1 Press Release Johnson & Johnson MedTech to Highlight Latest Advancements in Heart Disease Treatment with Impella at ACC.25 Press Release RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) outperforms osimertinib with a significant and unprecedented overall survival benefit in patients with EGFR-mutated non-small cell lung cancer Press Release New nipocalimab data and real-world research at AAN 2025 highlight positive Phase 3 results and commitment to people living with generalized myasthenia gravis (gMG) Press Release RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) significantly outperforms standard of care in first-line EGFR-mutated lung cancer with compelling new data at ELCC 2025 Press Release Johnson & Johnson MedTech Showcases New Era of Digital Orthopaedics at AAOS 2025 Press Release Icotrokinra meets primary endpoint of clinical response in ulcerative colitis study and shows potential to transform the treatment paradigm for patients Press Release Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis Press Release TREMFYA (guselkumab) subcutaneous (SC) induction data support potential to be the first and only in its class to offer the option of both intravenous and SC induction therapy in ulcerative colitis Press Release New nipocalimab data published in mAbs journal details differentiated molecular design, clinical profile and potential of nipocalimab to treat IgG-driven alloantibody and autoantibody diseases Press Release Findings from pivotal nipocalimab Phase 3 study in a broad antibody positive population of people living with generalized myasthenia gravis (gMG) published in The Lancet Neurology Press Release Product Launch Shockwave Medical Launches Novel Forward Intravascular Lithotripsy Platform in U.S. to Transform Treatment of Difficult-to-Cross Calcified Lesions Press Release Other Johnson & Johnson Closes Landmark Intra-Cellular Therapies, Inc. Acquisition to Solidify Neuroscience Leadership1 Press Release Johnson & Johnson to Return to Tort System to Defeat Meritless Talc Claims1 Press Release Johnson & Johnson Increases U.S. Investment to More than $55 Billion Over the Next Four Years Press Release Johnson & Johnson Announces Darren Snellgrove as Vice President, Investor Relations Press Release Webcast information: Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company's website at events-and-presentations. About Johnson & Johnson: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at www.jnj.com. Non-GAAP financial measures: * “Operational sales growth” excluding the impact of translational currency, “adjusted operational sales growth” excluding the net impact of acquisitions and divestitures and translational currency, as well as “adjusted net earnings”, “adjusted diluted earnings per share” and “adjusted operational diluted earnings per share” excluding after-tax intangible amortization expense and special items, are non-GAAP financial measures and should not be considered replacements for, and should be read together with, the most comparable GAAP financial measures. Except for guidance measures, reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying financial schedules of the earnings release and the Investor Relations section of the company's website at quarterly results. Copies of the financial schedules accompanying this earnings release are available on the company’s website at quarterly results. These schedules include supplementary sales data, a condensed consolidated statement of earnings, reconciliations of non-GAAP financial measures, and sales of key products/franchises. Additional information on Johnson & Johnson, including adjusted income before tax by segment, an Innovative Medicine pipeline of selected compounds in late stage development and a copy of today’s earnings call presentation can also be found in the Investor Relations section of the company's website at quarterly results. Note to investors concerning forward-looking statements: This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things: future operating and financial performance, product development, and market position and business strategy. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations or changes to applicable laws and regulations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products; challenges to patents; the impact of patent expirations; the ability of the Company to successfully execute strategic plans, including restructuring plans; the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability claims; changes to applicable laws and regulations, including tax laws and global health care reforms; trends toward health care cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and legal systems and sovereign risk; and increased scrutiny of the health care industry by government agencies. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Any forward-looking statement made in this release speaks only as of the date of this release. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Percent Change 2025 2024 Total Operations Currency $ 8,092 7,612 6.3 % 6.3 - 5,781 5,950 (2.9 ) 1.5 (4.4 ) 13,873 13,562 2.3 4.2 (1.9 ) 4,213 4,008 5.1 5.1 - 3,807 3,813 (0.2 ) 3.0 (3.2 ) 8,020 7,821 2.5 4.1 (1.6 ) 12,305 11,620 5.9 5.9 - 9,588 9,763 (1.8 ) 2.1 (3.9 ) $ 21,893 21,383 2.4 % 4.2 (1.8 ) Percent Change 2025 2024 Total Operations Currency $ 12,305 11,620 5.9 % 5.9 - 5,110 5,163 (1.0 ) 2.2 (3.2 ) 1,167 1,194 (2.3 ) 9.2 (11.5 ) 3,311 3,406 (2.8 ) (0.6 ) (2.2 ) 9,588 9,763 (1.8 ) 2.1 (3.9 ) $ 21,893 21,383 2.4 % 4.2 (1.8 ) 2025 2024 Percent Percent Percent Increase Amount to Sales Amount to Sales (Decrease) $ 21,893 100.0 $ 21,383 100.0 2.4 7,357 33.6 6,511 30.4 13.0 14,536 66.4 14,872 69.6 (2.3 ) 5,112 23.3 5,257 24.6 (2.8 ) 3,225 14.7 3,542 16.6 (8.9 ) (128 ) (0.6 ) (209 ) (1.0 ) (7,321 ) (33.4 ) 2,404 11.2 17 0.1 164 0.8 13,631 62.3 3,714 17.4 267.0 2,632 12.1 459 2.2 473.4 $ 10,999 50.2 $ 3,255 15.2 237.9 $ 4.54 $ 1.34 238.8 2,423.8 2,430.1 19.3 % 12.4 % $ 8,011 36.6 $ 7,877 36.8 1.7 $ 6,706 30.6 $ 6,580 30.8 1.9 $ 2.77 $ 2.71 2.2 16.3 % 16.5 % 2025 2024 $10,999 $3,255 (6,966) 2,726 1,120 1,078 55 171 132 148 39 (20) - 51 - 9 1,315 (856) 12 18 $6,706 $6,580 2,423.8 2,430.1 $2.77 $2.71 $2.81 1 2 2.3% 2.5% 2.4% 6.3% 5.1% 5.9% (2.9)% (0.2)% (1.8)% (1.9) (1.6) (1.8) - - - (4.4) (3.2) (3.9) 4.2% 4.1% 4.2% 6.3% 5.1% 5.9% 1.5% 3.0% 2.1% (3.3) (1.2) (5.1) (1.8) (1.4) (0.5) 0.2 0.5 0.3 0.0 0.9 0.3 0.4 0.2 0.3 4.4% 1.3% 3.3% 6.3% 0.9% 4.4% 1.9% 1.8% 1.9% REPORTED SALES vs. PRIOR PERIOD ($MM) 2025 2024 Reported Operational (1) Currency $ 3,013 2,383 26.4 % 26.4 % - 2,664 2,430 9.6 % 14.4 % -4.8 % 5,678 4,814 17.9 % 20.4 % -2.5 % 318 140 * * - 51 16 * * * 369 157 * * * 1,829 1,464 24.9 % 24.9 % - 1,409 1,228 14.7 % 19.8 % -5.1 % 3,237 2,692 20.3 % 22.5 % -2.2 % 292 285 2.5 % 2.5 % - 479 404 18.5 % 23.1 % -4.6 % 771 689 11.9 % 14.6 % -2.7 % 235 265 -11.5 % -11.5 % - 474 518 -8.5 % -4.2 % -4.3 % 709 784 -9.5 % -6.7 % -2.8 % 113 36 * * - 28 11 * * * 141 47 * * * 68 50 35.2 % 35.2 % - 18 8 * * * 86 58 48.4 % 50.2 % -1.8 % 105 101 4.9 % 4.9 % - 46 33 38.8 % 45.9 % -7.1 % 151 133 13.3 % 15.0 % -1.7 % 7 9 -24.3 % -24.3 % - 118 172 -31.3 % -28.5 % -2.8 % 125 181 -30.9 % -28.3 % -2.6 % 47 33 42.9 % 42.9 % - 42 41 4.6 % 10.1 % -5.5 % 89 73 21.7 % 24.7 % -3.0 % REPORTED SALES vs. PRIOR PERIOD ($MM) 2025 2024 Reported Operational (1) Currency 2,196 2,453 -10.5 % -10.5 % - 1,510 1,794 -15.8 % -11.5 % -4.3 % 3,707 4,247 -12.7 % -10.9 % -1.8 % 314 266 18.1 % 18.1 % - 10 27 -64.2 % -64.2 % - 143 141 1.3 % 6.8 % -5.5 % 467 434 7.5 % 9.3 % -1.8 % 292 254 14.8 % 14.8 % - 366 299 22.4 % 29.7 % -7.3 % 659 554 18.9 % 22.9 % -4.0 % 981 1,396 -29.8 % -29.8 % - 644 1,055 -38.9 % -35.8 % -3.1 % 1,625 2,451 -33.7 % -32.3 % -1.4 % 599 509 17.6 % 17.6 % - 356 299 19.2 % 24.4 % -5.2 % 956 808 18.2 % 20.1 % -1.9 % 1 0 * * - 0 0 - - - 1 0 * * - 968 1,054 -8.1 % -8.1 % - 679 749 -9.3 % -5.5 % -3.8 % 1,647 1,803 -8.6 % -7.0 % -1.6 % 38 41 -7.4 % -7.4 % - 110 136 -18.9 % -15.2 % -3.7 % 148 177 -16.3 % -13.4 % -2.9 % 625 765 -18.2 % -18.2 % - 277 292 -4.9 % -1.1 % -3.8 % 903 1,056 -14.5 % -13.5 % -1.0 % 276 191 45.0 % 45.0 % - 43 34 25.0 % 31.7 % -6.7 % 320 225 41.9 % 42.9 % -1.0 % 28 58 -50.6 % -50.6 % - 248 287 -13.4 % -9.8 % -3.6 % 277 345 -19.6 % -16.7 % -2.9 % REPORTED SALES vs. PRIOR PERIOD ($MM) 2025 2024 Reported Operational (1) Currency 744 766 -2.9 % -2.9 % - 281 283 -0.6 % 3.2 % -3.8 % 1,025 1,049 -2.3 % -1.2 % -1.1 % 363 356 2.1 % 2.1 % - 159 169 -6.0 % -2.5 % -3.5 % 522 524 -0.5 % 0.6 % -1.1 % 365 392 -6.9 % -6.9 % - 86 76 13.4 % 17.5 % -4.1 % 451 468 -3.6 % -2.9 % -0.7 % 15 18 -12.7 % -12.7 % - 37 39 -4.6 % -0.3 % -4.3 % 52 56 -7.2 % -4.3 % -2.9 % 315 324 -2.8 % -2.8 % - 487 497 -1.9 % 1.9 % -3.8 % 802 821 -2.2 % 0.1 % -2.3 % 8 8 -1.3 % -1.3 % - 350 315 11.0 % 14.7 % -3.7 % 358 323 10.7 % 14.3 % -3.6 % 305 314 -2.9 % -2.9 % - 98 104 -6.2 % -0.6 % -5.6 % 403 418 -3.7 % -2.3 % -1.4 % 2 2 7.7 % 7.7 % - 39 77 -48.8 % -47.0 % -1.8 % 41 78 -47.6 % -45.9 % -1.7 % 855 631 35.4 % 35.4 % - 158 197 -19.7 % -15.3 % -4.4 % 1,013 829 22.3 % 23.4 % -1.1 % 690 518 33.3 % 33.3 % - - - - - - 690 518 33.3 % 33.3 % - 165 114 45.0 % 45.0 % - 158 197 -19.7 % -15.3 % -4.4 % 323 311 3.9 % 6.7 % -2.8 % 8,092 7,612 6.3 % 6.3 % - 5,781 5,950 -2.9 % 1.5 % -4.4 % $ 13,873 13,562 2.3 % 4.2 % -1.9 % REPORTED SALES vs. PRIOR PERIOD ($MM) FIRST QUARTER % Change 2025 2024 Reported Operational (1) Currency $ 1,261 1,025 23.0 % 23.0 % - 842 781 7.8 % 10.7 % -2.9 % 2,103 1,806 16.4 % 17.7 % -1.3 % 684 692 -1.1 % -1.1 % - 638 652 -2.0 % 0.7 % -2.7 % 1,323 1,344 -1.6 % -0.2 % -1.4 % 339 303 11.9 % 11.9 % - 81 67 19.7 % 23.6 % -3.9 % 420 371 13.3 % 14.0 % -0.7 % 206 - * * - 52 - * * - 258 - * * - 32 30 7.1 % 7.1 % - 72 62 15.1 % 17.4 % -2.3 % 103 92 12.5 % 14.1 % -1.6 % 1,384 1,448 -4.4 % -4.4 % - 857 892 -3.9 % -0.9 % -3.0 % 2,241 2,340 -4.2 % -3.1 % -1.1 % 263 270 -2.5 % -2.5 % - 146 152 -4.0 % -0.8 % -3.2 % 409 422 -3.1 % -1.9 % -1.2 % 231 242 -4.3 % -4.3 % - 158 160 -1.0 % 2.1 % -3.1 % 389 401 -3.0 % -1.7 % -1.3 % 502 504 -0.5 % -0.5 % - 270 261 3.7 % 7.2 % -3.5 % 772 765 0.9 % 2.1 % -1.2 % 388 432 -10.2 % -10.2 % - 283 320 -11.6 % -8.9 % -2.7 % 671 752 -10.8 % -9.7 % -1.1 % REPORTED SALES vs. PRIOR PERIOD ($MM) FIRST QUARTER % Change 2025 2024 Reported Operational (1) Currency 1,002 987 1.5 % 1.5 % - 1,394 1,429 -2.5 % 0.8 % -3.3 % 2,396 2,416 -0.8 % 1.1 % -1.9 % 457 446 2.7 % 2.7 % - 616 641 -4.0 % -1.0 % -3.0 % 1,073 1,087 -1.2 % 0.5 % -1.7 % 544 542 0.5 % 0.5 % - 778 788 -1.2 % 2.3 % -3.5 % 1,323 1,330 -0.5 % 1.6 % -2.1 % 566 547 3.4 % 3.4 % - 713 710 0.4 % 3.9 % -3.5 % 1,279 1,258 1.7 % 3.7 % -2.0 % 452 438 3.1 % 3.1 % - 467 472 -1.1 % 2.4 % -3.5 % 919 910 1.0 % 2.7 % -1.7 % 114 110 4.3 % 4.3 % - 246 238 3.4 % 7.1 % -3.7 % 361 348 3.7 % 6.2 % -2.5 % 4,213 4,008 5.1 % 5.1 % - 3,807 3,813 -0.2 % 3.0 % -3.2 % $ 8,020 7,821 2.5 % 4.1 % -1.6 % 2023 2024 2024 Full Year Q1 Q2 Q3 Q4 Full Year 66 36 52 68 101 257 27 11 17 21 21 70 93 47 69 89 122 327 56 50 59 64 68 241 7 8 9 12 17 46 63 58 69 75 85 287 93 33 37 36 39 145 235 41 45 50 36 172 328 73 83 86 75 317 1,292 356 376 417 408 1,557 681 169 171 166 162 668 1,973 524 548 583 570 2,225 79 18 17 21 19 75 182 39 49 39 38 165 260 56 67 60 57 240 19 2 5 3 1 11 1,395 77 227 54 43 401 1,414 78 233 56 45 412 First Quarter March 30, 2025 GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related First Quarter March 30, 2025 Non-GAAP $ 4,020 (649 ) 3,371 2,261 2,261 2,548 2,548 (166 ) - - - (20 ) (18 ) - (204 ) 5,210 649 - - 20 18 - 5,897 First Quarter March 30, 2025 GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related First Quarter March 30, 2025 Non-GAAP $ 3,326 (471 ) (8 ) (52 ) 2,795 2,656 2,656 677 (6 ) 671 (60 ) - - (47 ) (54 ) (21 ) - (182 ) 1,421 471 - 55 112 21 - 2,080 First Quarter March 30, 2025 GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related First Quarter March 30, 2025 Non-GAAP $ 11 11 195 195 - (7,206 ) - 6,966 - - - - (240 ) 7,000 - (6,966 ) - - - - 34 First Quarter March 30, 2025 GAAP Intangible asset amortization Litigation related Restructuring related Acquisition, integration and divestiture related (Loss)/gain on securities Tax legislation and other tax related First Quarter March 30, 2025 Non-GAAP $ 7,357 (1,120 ) (8 ) (52 ) - 6,177 5,112 5,112 3,225 (6 ) 3,219 (7,321 ) - 6,966 (30 ) (74 ) (39 ) (498 ) - - (128 ) (128 ) 17 (17 ) - 13,631 1,120 (6,966 ) 55 132 39 - 8,011 2,632 188 (1,553 ) 11 30 9 (12 ) 1,305 10,999 932 (5,413 ) 44 102 30 12 6,706 $ 3,370 (698 ) (2 ) 2,670 2,438 2,438 2,896 (7 ) 2,889 (111 ) (144 ) (47 ) 55 (247 ) 4,969 698 - 144 47 (55 ) - 9 - 5,812 $ 3,120 (380 ) (7 ) (20 ) 2,713 2,582 (4 ) 2,578 646 (18 ) (27 ) 601 (47 ) (20 ) (43 ) (22 ) (132 ) 1,520 380 - 27 61 22 51 - - 2,061 $ 21 21 237 237 - - 2,517 (2,726 ) (40 ) (13 ) (262 ) (2,775 ) - 2,726 - 40 13 - - - 4 $ 6,511 (1,078 ) (7 ) (20 ) (2 ) 5,404 5,257 (4 ) 5,253 3,542 (18 ) (27 ) (7 ) 3,490 2,404 (2,726 ) (130 ) 20 (432 ) - - (209 ) (209 ) 164 (164 ) - 3,714 1,078 2,726 171 148 (20 ) 51 9 - 7,877 459 148 627 39 38 (7 ) 9 2 (18 ) 1,297 3,255 930 2,099 132 110 (13 ) 42 7 18 6,580 Media contact: media-relations@its.jnj.com Investor contact: investor-relations@its.jnj.com

Clinical ResultPhase 3Breakthrough TherapyDrug ApprovalFinancial Statement

10 Apr 2025

·endpts.com

J&J, argenx keep rolling out myasthenia gravis data, plus more from #AAN25

Last weekend, researchers gathered in San Diego for the American Academy of Neurology’s annual meeting to discuss the latest advancements and clinical trial data across the neuroscience field. Among the most intensely watched spaces is myasthenia gravis, in which a handful of approvals are soon expected to be challenged by up-and-coming drug programs. UCB and argenx are the primary players currently, along with AstraZeneca/Alexion’s Soliris and Ultomiris franchises. But others may soon join the market, with drugs from J&J, Amgen and Immunovant all in late-stage development. Biohaven also has a program that’s expected to start Phase 1 studies in myasthenia gravis before the end of June, and Cartesian reported data for its cell therapy program earlier this week. Nipocalimab is a major part of J&J’s R&D portfolio. Company executives projected peak sales of at least $5 billion across a potential 10 indications. Myasthenia gravis is first among those efforts, with nipocalimab succeeding in its Phase 3 trial last year. J&J outlined longer-term data for people who participated in that trial, including patients who originally received placebo in the double-blinded portion and then crossed over into taking the drug. After 84 weeks, J&J said nipocalimab resulted in sustained disease control in both groups of patients. The randomized period was 24 weeks, and the open-label follow-up was 60 weeks. Patients who received placebo first and then crossed over had nearly identical mean levels of IgG after the 60-week period, with the levels dropping within the first few weeks. J&J’s executive director of neuroscience Sindhu Ramchandren said because myasthenia gravis is a chronic disease, the data showing nipocalimab’s effectiveness over time helps boost its case overall. “I think of it like diabetes,” she said. “You don’t treat diabetes by just taking insulin for a limited period of time and then hope that it gets cured. In a chronic disease, you need to take your treatments chronically.” J&J submitted its application to the FDA last Aug. 29, and said in January that it received priority review for nipocalimab in myasthenia gravis. Though a PDUFA date has not been disclosed, Wall Street expects a decision by the end of April. Vyvgart has been on the market for a while, first getting approval in December 2021. Argenx is continuing to move forward with other administration routes, getting FDA approval last year for the subcutaneous injection Vyvgart Hytrulo. The subcutaneous version also got FDA approval last year in a rare disease called CIDP (chronic inflammatory demyelinating polyneuropathy), and the company touted long-term data in both disease areas. For the original formulation, 75% of myasthenia gravis patients saw sustained improvement through two and a half years (126 weeks), while 56.5% saw “minimal symptom expression,” according to a press release. Vyvgart Hytrulo, meanwhile, showed long-term benefits in CIDP. Argenx said the drug induced improvements after 36 weeks compared to baseline. The company is continuing to collect real-world data in order to confirm the benefit seen in the pivotal trial. “Stabilization usually has been the target, but now that we have long-term data, there’s an impression people are better off with long-term treatment,” argenx CMO Luc Truyen said. “So that, I think, is important and should be a driver for the field to test.” A third formulation of Vyvgart that uses a self-injector is also under review at the FDA. Regulators are expected to make a decision by the end of April 10. More dispatches:

Clinical ResultPhase 3Drug ApprovalPriority ReviewCell Therapy

08 Apr 2025

·www.fiercebiotech.com

J&J links FcRn blocker to sustained benefits as FDA ruling on potential blockbuster nears

J&J acquired nipocalimab in its $6.5 billion takeover of Momenta. \n Johnson & Johnson has reinforced a key plank of its plan to build nipocalimab into a $5 billion medicine, reporting that the benefits seen earlier in a phase 3 autoimmune trial persisted through Week 60 of the open-label extension.The FDA is reviewing a request for approval of FcRn blocker nipocalimab in generalized myasthenia gravis (gMG). J&J is late to the party, with argenx and UCB already selling rival FcRn blockers, but has bet big in the belief nipocalimab has advantages over the competition. Ongoing dosing with argenx’s Vyvgart and UCB’s Rystiggo is based on clinical evaluation. J&J has studied consistent dosing of nipocalimab.The Big Pharma previously reported a 5.73-point reduction on a gMG symptom scale after 24 weeks of the open-label extension. The reduction hit 5.97 points at Week 48. Tuesday, J&J published the latest cut of data from the ongoing extension trial, reporting a reduction of 5.64 points after 60 weeks.The average symptom score fell 6.01 points in people who switched to nipocalimab from placebo after the trial’s double-blind period. Forty-five percent of antibody-positive patients reduced or discontinued steroids. The mean dose of the steroid prednisone decreased from 23 mg to 10 mg a day. If the FDA approves nipocalimab, the long-term data could form part of J&J’s pitch for the gMG market. The labels for argenx’s Vyvgart, in its intravenous and subcutaneous forms, state the safety of delivering ongoing doses less than 50 days apart hasn’t been established. The figure for UCB’s Rystiggo is 63 days.J&J, which acquired nipocalimab in its $6.5 billion takeover of Momenta Pharmaceuticals, has made the case that its FcRn blocker should be safer than rival molecules because it is highly specific to the IgG binding site without overlap on the albumin binding site. Consistent nipocalimab dosing could support sustained disease control, strengthening J&J’s play for the gMG market and other indications.However, the company will face a well-established rival in gMG. Argenx won approval in 2021 and later launched a subcutaneous version. The biotech has pointed to the established safety profile of Vyvgart as a factor that could help it hold off competition.

Clinical ResultPhase 3Drug ApprovalAcquisitionPost-Marketing Study

100 Deals associated with Nipocalimab

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D11666	-	-	DB16257

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	NDA/BLA	Canada	Janssen Research & Development LLC	01 Jan 2025
Myasthenia Gravis	NDA/BLA	United States	Johnson & Johnson (China) Investment Ltd.	29 Aug 2024
Sjogren's Syndrome	Phase 3	United States	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Japan	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Argentina	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Brazil	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Mexico	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	Taiwan Province	Janssen Research & Development LLC	04 Dec 2024
Sjogren's Syndrome	Phase 3	United Kingdom	Janssen Research & Development LLC	04 Dec 2024
Fetal and neonatal alloimmune thrombocytopenia	Phase 3	Belgium	Janssen Research & Development LLC	11 Nov 2024

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04951622 (Vivacity-MG3, AAN2025) Manual	Phase 3	Myasthenia Gravis	137	Nipocalimab+standard-of-care therapy	rquijvzfvd(gyjdzszfob) = mdfsmnnkeo miwebolihi (pdjslmqmtn, 0.401) View more	Positive	07 Apr 2025
NCT04951622 (Vivacity-MG3, Lancet) Manual	Phase 3	Myasthenia Gravis	196	Nipocalimab	ecsfhrxnmz(fjhkmkezur) = nmoaptsdmt whgntqseem (cktohnprbq, 0.329) Met	Positive	01 Feb 2025
				Placebo	ecsfhrxnmz(fjhkmkezur) = pyjgiegmnn whgntqseem (cktohnprbq, 0.335) Met
NCT04968912 (DAHLIAS, ACR2024) Manual	Phase 2	Sjogren's Syndrome	163	Placebo	ccenbphojc(cnlwkuayrc) = aklmhrocbq smrezfmwxp (ipmmebpjht, -4.74 to -2.75) Met View more	Positive	18 Nov 2024
				nipocalimab 5 mg/kg	ccenbphojc(cnlwkuayrc) = jwnrujsueb smrezfmwxp (ipmmebpjht, -5.10 to -3.07) Met View more
NCT04968912 (DAHLIAS, ACR2024) Manual	Phase 2	Sjogren's Syndrome	163	nipocalimab 5 mg/kg	xwvnlysyfx(rlwwjqnudm) = qoermyctzl vcudlxgckk (byykumdnvb )	Positive	18 Nov 2024
				nipocalimab 15 mg/kg	xwvnlysyfx(rlwwjqnudm) = wdhgjxdlrc vcudlxgckk (byykumdnvb, -66， - 46)
NCT04968912 (DAHLIAS, ACR2024) Manual	Phase 2	Sjogren's Syndrome	163	Nipocalimab 5 mg/kg	nmfsmgftml(ovpubzccyj) = occuowfcww ynxpyewcep (jlpyrtqrog ) View more	Positive	17 Nov 2024
				Nipocalimab 15 mg/kg	nmfsmgftml(ovpubzccyj) = gbjbsvntbd ynxpyewcep (jlpyrtqrog ) View more
NCT05265273 (Vibrance-MG, Corporate Publications) Manual	Phase 2/3	Myasthenia Gravis	7	Nipocalimab plus standard of care (SOC)	lejxyewrbq(vokaiflkqb) = civkyteqqa mnpnyypldx (cmztswggwe ) Met View more	Positive	15 Oct 2024
NCT03842189 (UNITY, Pubmed \| N Engl J Med)	Phase 2	Erythroblastosis, Fetal maternal antierythrocyte IgG alloantibodies	13	Nipocalimab 30 mg/kg	vhgpnypiev(wrjwthspnu) = consistent with HDFN, pregnancy, or prematurity itkqstdrib (skbmlwssau )	Positive	08 Aug 2024
NCT04951622 (Vivacity-MG3, GlobeNewswire) Manual	Phase 3	Myasthenia Gravis anti-AChR+ \| anti-MuSK+ \| anti-LRP4+	153	nipocalimab plus SOC	lhexmvutaw(amijdixvtt) = bnrtbyfppd kqetapwgls (pocekwjcxy ) Met View more	Positive	28 Jun 2024
				Placebo plus SOC	lhexmvutaw(amijdixvtt) = jxgcefdcot kqetapwgls (pocekwjcxy ) Met View more
NCT04968912 (DAHLIAS, EULAR 12024 \| EULAR 22024) Manual	Phase 2	Sjogren's Syndrome	163	NIPOCALIMAB 5 mg/kg	yncnqvbqep(zbycucelie) = gdfumlnqjk qnuvjwvvux (hsnwrfpnvd, -5.10 to -3.07) View more	Positive	12 Jun 2024
				NIPOCALIMAB 15 mg/kg	yncnqvbqep(zbycucelie) = kryzttrtyf qnuvjwvvux (hsnwrfpnvd, -7.43 to -5.36) View more
NCT04968912 (DAHLIAS , Corporate Publications) Manual	Phase 2	Sjogren's Syndrome	-	Nipocalimab	ttyxldpvxh(gfftfmeiuh) = with a statistically significant reduction in clinESSDAIb score from baseline at week 24 compared with placebo (PBO) mzlpbtqfwx (egaazhvzaf ) Met	Positive	05 Feb 2024
				placebo

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