Johnson & Johnson presents new data further reinforcing the role of nipocalimab in lowering the autoantibodies driving Sjögren's disease
Rhea-AI Summary
Johnson & Johnson (NYSE:JNJ) reported new exploratory biomarker analyses from the Phase 2 DAHLIAS study of nipocalimab in adults with moderate-to-severe Sjögren's disease.
Participants with elevated disease-driving autoantibodies and IgG levels achieved 62.5% response on nipocalimab versus 51.9% overall, supporting ongoing Phase 3 DAFFODIL evaluation. Nipocalimab holds FDA Breakthrough and Fast Track designations for this indication but is not yet approved.
Positive
- Autoantibody-high subgroup response rate 62.5% vs 51.9% overall on nipocalimab
- Phase 2 DAHLIAS showed statistically significant ClinESSDAI improvement vs placebo
- Nipocalimab being advanced into Phase 3 DAFFODIL study for Sjögren's disease
- Only FcRn blocker with FDA Breakthrough and Fast Track in Sjögren's disease
Negative
- Nipocalimab is not FDA approved for treatment of Sjögren's disease
- Current findings are exploratory Phase 2 biomarker analyses, not definitive outcomes
News Market Reaction – JNJ
In the Jun 3 session, JNJ gained 0.16%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 29 | Oncology trial update | Positive | -2.4% | Updated Phase 1/1b RYBREVANT plus LAZCLUZE survival data in atypical EGFR NSCLC. |
| May 29 | Oncology Phase 3 data | Positive | -2.4% | TECVAYLI Phase 3 showed improved PFS and OS vs standard regimens in myeloma. |
| May 28 | FDA label expansion | Positive | -2.4% | FDA approved TREMFYA label expansion showing inhibition of joint damage progression. |
| May 27 | Earnings call notice | Neutral | -0.2% | Announcement of upcoming second-quarter investor conference call and webcast details. |
| May 14 | Survey on burden | Neutral | -1.8% | Global survey highlighted quality-of-life burden in non–muscle-invasive bladder cancer. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent positive R&D and regulatory updates have often coincided with modest negative next-day moves, indicating a pattern of divergence between upbeat news and short-term price reaction.
Over the past few weeks, Johnson & Johnson has delivered multiple positive updates across its pharmaceutical portfolio. Late May saw strong data for RYBREVANT plus LAZCLUZE in atypical EGFR-mutated NSCLC and superior survival outcomes for TECVAYLI in multiple myeloma, alongside an FDA label expansion for TREMFYA in psoriatic arthritis. Despite these constructive developments, next-day price reactions around -2.37% were negative. The current Sjögren’s disease Phase 2 nipocalimab data fit this pattern of clinically encouraging news amid subdued price responses.
Key Terms
neonatal fc receptor (fcrn) medical
fcrn blocker medical
immunoglobulin g (igg) medical
autoantibodies medical
breakthrough therapy designation regulatory
fast track designation regulatory
biomarker medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Nipocalimab, an immunoselective neonatal Fc receptor (FcRn) blocker, is designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with Sjögren's disease while preserving immune function
- New exploratory analysis of Phase 2 study data shows a strong correlation between autoantibody levels and even greater clinical response rates of participants in the nipocalimab treatment group
- Previously reported data from the Phase 2 study showed nipocalimab reduced Sjögren's disease activity and severity, with potential to address systemic manifestations and the most burdensome patient-reported symptoms including dryness, fatigue and pain
- Nipocalimab is the only FcRn blocker granted both Breakthrough Therapy Designation and Fast Track Designation by the
U.S . FDA for the treatment of adults with moderate-to-severe Sjögren's disease.
A healthcare professional's perspective
"Sjögren's disease is a highly heterogeneous condition that has historically posed significant challenges for therapeutic development, leaving gaps in patient care," said R. Hal Scofield, M.D., the University of
New DAHLIAS Phase 2 clinical and biomarker findings
Clinical improvements were observed across all patients, with the greatest responses observed in participants with elevated known disease-driving autoantibodies and IgG levels – factors associated with more severe SjD activity and outcomes.1 Previously reported positive Phase 2 study results demonstrated statistically significant improvement in ClinESSDAId scores with nipocalimab versus placebo.2 In the current analysis, patients in the autoantibody-high subgroupb treated with nipocalimab achieved higher response rates than observed in the overall participant population (
Biomarker analyses reveal autoantibody and immune function insights
These findings further support the underlying mechanism of action of nipocalimab as a targeted, immunoselective approach designed to reduce pathogenic IgG autoantibodies associated with SjD disease activity while preserving broader immune function.3
"The biomarker analyses are consistent with the hypothesized mechanism of nipocalimab in Sjögren's disease. These findings suggest greater response in the broad study population of adults with moderate-to-severe Sjögren's disease, plus a greater response observed among patients with elevated disease-driving autoantibodies and immunoglobulin G levels," said Leonard L. Dragone, M.D., Ph.D., Disease Area Leader, Autoantibody and Rheumatology, Johnson & Johnson. "The data also furthers our understanding of the role pathogenic IgG autoantibodies may play in this heterogenous disease as we continue to investigate nipocalimab in Sjögren's."
Editor's Notes:
a. | Nipocalimab is not FDA approved for the treatment of SjD. |
b. | Subgroup included patients with moderate-to-severe SjD who had the highest baseline levels of three disease-associated autoantibodies – anti-Ro60, anti-Ro52 and anti-La – measured in the study population. |
c. | Dr. Scofield is a paid consultant for Johnson & Johnson. He has not been compensated for any media work. |
d. | ClinESSDAI is an endpoint specific to SjD and is a composite scale that assesses organ disease activity across 11 organ system domains [cutaneous, pulmonary, renal, articular, muscular, peripheral nervous system (PNS), central nervous system (CNS), hematological, glandular, constitutional, lymphadenopathy and lymphoma; a higher score indicates greater symptom severity. |
ABOUT DAHLIAS
DAHLIAS (NCT04968912) is a Phase 2 multicenter, randomized, placebo-controlled double-blind, dose-ranging study to evaluate the effects of nipocalimab in participants with moderately-to-severely active primary Sjögren's disease (SjD) who were seropositive for anti-Ro60 and/or anti-Ro52 immunoglobulin G (IgG) antibodies. 163 adults aged 18-75 were randomized 1:1:1 to receive intravenous nipocalimab at 5 or 15 mg/kg, or placebo every 2 weeks through Week 22 and received protocol-permitted background standard of care. Safety assessments were conducted through Week 30. The primary endpoint was change in baseline in the ClinESSDAI (Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index) Score at Week 24. 4
ABOUT SJÖGREN'S DISEASE
Sjögren's disease (SjD) is one of the most prevalent autoantibody-driven diseases for which no therapies are currently approved that treat the underlying and systemic nature of the disease.5 It is a chronic autoimmune disease that is estimated to impact approximately four million people worldwide and is nine times more common in women than men.6 SjD is characterized by autoantibody production, chronic inflammation and lymphocytic infiltration of exocrine glands.7 Most patients are affected by mucosal dryness (eyes, mouth, vagina), joint pain and fatigue.8 More than
ABOUT NIPOCALIMAB
Nipocalimab is an investigational immunoselective treatment designed to target, bind with high affinity and block neonatal Fc receptor (FcRn), reducing circulating immunoglobulin (IgG) antibodies that drive disease while also preserving key immune functions.13,14 Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic diseases, Rare Autoantibody diseases andMaternal Fetal diseases mediated by maternal alloantibodies in which blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus.4,15,16,17,18,19,20,21,22
The
- EU EMA Orphan medicinal product designation for hemolytic disease of the fetus and newborn (HDFN) in October 2019 and fetal and neonatal alloimmune thrombocytopenia (FNAIT) in April 2025
U.S . FDA Fast Track designation in HDFN and warm autoimmune hemolytic anemia (wAIHA) in July 2019, generalized myasthenia gravis (gMG) in December 2021, FNAIT in March 2024, Sjögren's disease (SjD) in March 2025 and systemic lupus erythematosus (SLE) in January 2026U.S . FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023U.S . FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024U.S . FDA granted Priority Review in gMG in Q4 2024 and wAIHA in Q2 2026
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 https://www.jnj.com/ or at www.innovativemedicine.jnj.com.
Follow us at @JNJInnovMed.
Janssen Biotech, Inc. is a Johnson & Johnson company.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. 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: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. 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. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
1 Scofield, H et al. Biomarker-Driven Insights to Clinical Response in DAHLIAS: A Nipocalimab Trial for Sjogren's Disease. Presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress. Oral Presentation #OP0131
2 Noaiseh, G et al., Efficacy and safety of nipocalimab in patients with moderate-to-severe Sjögren's disease (DAHLIAS): a randomised, phase 2, placebo-controlled, double-blind trial. The Lancet. Oct 2025; Nov 22;406(10518):2435-2448.
3 Seth NP, et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. MAbs. 2025 Dec;17(1):2461191.
4 ClinicalTrials.gov Identifier: NCT04968912. Available at: https://clinicaltrials.gov/study/NCT04968912. Last accessed: June 2026.
5 Huang H, et al. Mortality in patients with primary Sjögren's syndrome: a systematic review and meta-analysis. Rheumatology (Oxford). 2021 Sep 1;60(9):4029-4038. doi: 10.1093/rheumatology/keab364. PMID: 33878179
6 Beydon, M., et al. Epidemiology of Sjögren syndrome. Nat Rev Rheumatol. 2024 Mar;20(3):158-169. doi: 10.1038/s41584-023-01057-6.
7 Meudec L, Nocturne G, Mariette X. Update on the Aetiopathogenesis of Sjögren Disease: From Interferon Signaling to Epithelial Dysfunction. J Clin Med. 2026 Mar 4;15(5):1945. doi: 10.3390/jcm15051945
8 Mayo Clinic. Sjogren's syndrome. Available at: https://www.mayoclinic.org/diseases-conditions/sjogrens-syndrome/symptoms-causes/syc-20353216. Last accessed: June 2026.
9 Lim ZFS, et al. Regulatory T cell therapy for Sjögren's disease: From pathogenesis to targeted treatment. J Transl Autoimmun. 2025 Aug 26;11:100311. doi: 10.1016/j.jtauto.2025.100311.
10 Carsons SE, Patel BC. Sjogren Syndrome. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK431049/
11 Hackett KL, et al. Impaired functional status in primary Sjögren's syndrome. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1760-4.
12 Meijer JM, et al. Health-related quality of life, employment and disability in patients with Sjogren's syndrome. Rheumatology (Oxford). 2009 Sep;48(9):1077-82. doi: 10.1093/rheumatology/kep141. Epub 2009 Jun 24. PMID: 19553376.
13 Ling LE., et al. M281, an anti–fcrn antibody: Pharmacodynamics, pharmacokinetics, and safety across the full range of IGG reduction in a first–in–human study. Clinical Pharmacology & Therapeutics., 2018;105;4:1031–1039. Available at: https://doi.org/10.1002/cpt.1276.
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22 ClinicalTrials.gov Identifier: NCT06533098 Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: June 2026.
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Bridget Kimmel | Jess Margevich |
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