IMAAVY® (nipocalimab-aahu) shows over two years of sustained disease control in a broad population with generalized myasthenia gravis (gMG)
Rhea-AI Summary
Johnson & Johnson (NYSE: JNJ) reported long-term results for IMAAVY (nipocalimab-aahu) in antibody-positive adults with generalized myasthenia gravis, extending follow-up to 120 weeks. Key findings include sustained symptom improvements, mean MG-ADL reduction of 6.47 points, QMG reduction of 5.97, and durable IgG lowering.
Half of patients reached minimal symptom expression and 32% sustained it for at least 8 weeks; corticosteroid use fell with 57% at low doses. EPIC, a head-to-head study versus efgartigimod, is now enrolling.
Positive
- MG-ADL mean reduction of 6.47 points
- QMG mean reduction of 5.97 points
- 50% of patients achieved minimal symptom expression (MSE)
- 32% achieved sustained MSE for ≥8 weeks
- 64%+ reduction in total IgG levels
- 57% of patients reduced corticosteroids to ≤10 or ≤5 mg/day
Negative
- None.
News Market Reaction – JNJ
In the Apr 22 session, JNJ declined 0.03%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 15 | Conference participation | Neutral | -1.7% | Announcement of upcoming Bank of America 2026 Healthcare Conference fireside chat. |
| Apr 14 | Dividend increase | Positive | +0.9% | 64th consecutive annual dividend increase and 3.1% raise in quarterly payout. |
| Apr 14 | Earnings and guidance | Positive | +0.9% | Q1 2026 sales growth, adjusted EPS of $2.70 and higher 2026 sales/EPS outlook. |
| Apr 10 | Clinical data update | Positive | -1.2% | New TECNIS PureSee IOL data showing strong vision outcomes and high satisfaction. |
| Apr 07 | Product launch | Positive | -1.1% | European launch of VARIPULSE Pro pulsed field ablation system after CE Mark approval. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent history shows that even clearly positive operational or clinical updates have sometimes coincided with negative next-day moves, while earnings and dividend news have aligned with modest gains.
Over the past month, Johnson & Johnson reported several milestones. On April 14, 2026, it raised its 2026 sales outlook to $100.8 billion and boosted the quarterly dividend by 3.1%, with both earnings and dividend headlines followed by a 0.9% gain. In contrast, favorable MedTech launches and clinical data on April 7 and April 10 saw next-day declines of 1.06% and 1.18%. The current gMG data thus fits a pattern where strong clinical or product news has not always translated into immediate share price strength.
Key Terms
fcRn blocker medical
open label extension (OLE) medical
immunoglobulin g (igg) medical
autoantibodies medical
post-hoc analysis technical
mg-adl medical
mg-qol-15r medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Through 120 weeks of follow-up, IMAAVY delivered sustained clinical improvements and reductions in total IgG in antibody-positive adult patients including anti-AChR+ and anti-MuSK+
Patients achieving sustained minimal symptom expression (MSE) experienced greater improvements in quality of life than those with transient MSE in a post-hoc analysis of the Phase 3 study
EPIC, the first head-to-head study of IMAAVY versus another FcRn blocker in generalized myasthenia gravis, is now enrolling participants
"For people living with gMG, consistent and durable symptom control is the central goal of treatment," said Constantine Farmakidis, MD, Associate Professor of Neurology at the University of Kansas Medical Centerc. "These long-term results, now extending to beyond two years, provide further evidence that disease control, as initially observed in the nipocalimab Phase 3 pivotal study, can be sustained, and add to the body of evidence that may help guide clinical decision-making."
Sustained disease control is a key treatment objective in gMG, as long-term maintenance of low disease activity can help prevent exacerbations, reduce treatment burden and support meaningful function outcomes.i In addition, new post-hoc analyses explore the clinical relevance of sustained minimal symptom expression (MSE), an emerging patient-centric treatment goal that reflects minimal day-to-day disease impact for people living with gMG.ii
Long-Term Data from OLE Phaseiii
After the 24-week double-blind phase of the study, patients entered the ongoing OLE phase, with the latest results reflecting a total of 120 weeks of observation – among the longest follow-up periods reported for any FcRn blocker study in gMG. At 96 weeks in the OLE, IMAAVY demonstrated:
- Sustained improvements in MG-ADLd and QMGe scores over time, with mean reductions of 6.47f points on the total MG-ADL and 5.97f points on the total QMG scales – measures of MG symptom impact on daily living and muscle strength.
- Half of patients achieved MSE and nearly one-third (
32% ) achieved sustained MSE for at least 8 weeks on IMAAVY treatment. - Incremental reduction of corticosteroid use was also observed through the OLE, with
57% of patients reaching low doses of ≤10 or ≤5 mg/day. - Greater than
64% f reduction in total immunoglobulin G (IgG), including pathogenic IgG autoantibodies, the underlying driver of disease.
Minimal Symptom Expression Data from Double-Blind Phaseiv
A new post-hoc analysis from the 24-week double-blind portion of the study evaluated the impact of sustained MSE on quality of life (based on MG‑QoL‑15rg measure):
- Adults who received IMAAVY plus standard of care (SOC)h were four times more likely to reach sustained MSE, defined as achieving an MG-ADL score of 0 or 1 and maintaining it for at least 8 weeks, compared to those randomized to placebo.
- Patients who reached this level and sustainment of symptom control had the largest gains in day‑to‑day quality of life, compared with those with improvements that were not similarly sustained, or among those who did not attain MSE.
"As demonstrated in our pivotal trial, IMAAVY was shown to deliver sustained disease control in a broad population of people living with gMG, helping to address a critical unmet need," said Chris Gasink, MD, Vice President, Medical Affairs, Autoantibody & Gastroenterology, Johnson & Johnson. "These data reinforce our confidence in IMAAVY and our commitment to delivering treatments that can help more people living with gMG achieve meaningful, lasting disease control."
Additionally, Johnson & Johnson previously announced plans to initiate EPIC in 2025, the first open-label study designed to compare FcRn blockers in adults with gMG who have never received an FcRn blocker. The study, comparing the efficacy of IMAAVY versus efgartigimod, is now enrolling participants.
For a full list of all Johnson & Johnson data being presented at AAN 2026 visit: https://www.jnj.com/innovativemedicine/neuroscience/myasthenia-gravis.
Editor's Notes:
a. | AChR+ = anti-acetylcholine receptor positive antibody |
b. | MUsK+ = anti-muscle specific tyrosine kinase positive antibody |
c. | Constantine Farmakidis, MD, has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work. |
d. | MG-ADL (Myasthenia Gravis – Activities of Daily Living) provides a rapid clinical assessment of the patient's recall of symptoms impacting activities of daily living, with a total score range of 0 to 24; a higher score indicates greater symptom severity.v |
e. | QMG (Quantitative Myasthenia Gravis) is a 13-item assessment by a clinician that quantifies MG disease severity. The total QMG score ranges from 0 to 39, where higher scores indicate greater disease severity.vi |
f. | Results reflect patients receiving IMAAVY and SOC throughout both the 24-week double-blind phase and OLE phase of the study. |
g. | As measured by MG-QoL-15r (Myasthenia Gravis Quality of Life 15-item Scale – Revised), a scale designed to assess important aspects of the patient's experience related to MG.vii |
h. | Standard of care was defined as a stable dose of current gMG treatment, including acetylcholinesterase inhibitors, glucocorticosteroids or immunosupressants (ie, azathioprine, mycophenolate mofetil or mycophenolic acid, methotrexate, ciclosporin, tacrolimus, or cyclophosphamide).viii |
ABOUT GENERALIZED MYASTHENIA GRAVIS (gMG)
Myasthenia gravis (MG) is an autoantibody disease in which the immune system mistakenly makes antibodies (e.g., anti-acetylcholine receptor [AChR], anti-muscle-specific tyrosine kinase [MuSK]), which target proteins at the neuromuscular junction and can block or disrupt normal signaling from nerves to muscles, thus impairing or preventing muscle contraction.ix,x,xi The disease impacts an estimated 700,000 people worldwide.vii The disease affects both men and women and occurs across all ages, racial and ethnic groups, but most frequently starts in young women and older men.xii Roughly 50 percent of individuals diagnosed with MG are women, and about one in five of those women are of child-bearing potential.xiii,xiv,xv Approximately 10 to
Initial disease manifestations are usually eye-related but approximately
ABOUT THE PHASE 3 VIVACITY-MG3 STUDY
The Phase 3 Vivacity-MG3 study (NCT04951622) was specifically designed to measure sustained efficacy and safety with consistent dosing in this unpredictable chronic condition where unmet need remains high. Antibody positive or negative adult gMG patients with insufficient response (MG-ADL ≥6) to ongoing SOC therapy were identified and 199 patients, 153 of whom were antibody positive, enrolled in the 24-week double-blind placebo-controlled trial.xxix,xxx Randomization was 1:1, nipocalimab plus current SOC (30 mg/kg IV loading dose followed by 15 mg/kg every two weeks) or placebo plus current SOC.xxvii Baseline demographics were balanced across arms (77 nipocalimab, 76 placebo).xxvii The primary efficacy endpoint was the comparison of the mean change from baseline to Weeks 22, 23, and 24 between treatment groups in the MG-ADL total score.xxvii A key secondary endpoint included change in Quantitative Myasthenia Gravis (QMG) score. Long-term safety and efficacy were further assessed in an ongoing open-label extension (OLE) phase.xxviii
ABOUT IMAAVY (nipocalimab-aahu)
IMAAVY is an immunoselective treatment designed to target, bind with high affinity, and block FcRn, reducing circulating IgG antibodies that drive disease while also preserving key immune functions. IMAAVY is currently approved for the treatment of gMG in adults and pediatric patients 12 years of age and older who are AChR or MuSK antibody positive.xxxi
Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic diseases, Rare Autoantibody diseases, and Maternal Fetal diseases mediated by maternal alloantibodies, in which blockade of IgG binding to FcRn in the placenta is believed to limit transplacental transfer of maternal alloantibodies to the fetus.xxxii,xxxiii,xxxiv,xxxv,xxxvi,xxxvii,xxxviii,xxxix,xl
The
- EU EMA Orphan medicinal product designation for HDFN in October 2019 and FNAIT in April 2025
U.S. FDA Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, fetal and neonatal alloimmune thrombocytopenia (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
The legal manufacturer for IMAAVY is Janssen Biotech, Inc.
WHAT IS IMAAVY (nipocalimab-aahu)?
IMAAVY is a prescription medicine used to treat adults and children 12 years of age and older with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
It is not known if IMAAVY is safe and effective in children under 12 years of age.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about IMAAVY?
IMAAVY is a prescription medicine that may cause serious side effects, including:
- Infections are a common side effect of IMAAVY that can be serious. Receiving IMAAVY may increase your risk of infection. Tell your healthcare provider right away if you have any of the following infection symptoms:
|
|
- Allergic (hypersensitivity) reactions may happen during or up to a few weeks after your IMAAVY infusion. Get emergency medical help right away if you get any of these symptoms during or after your IMAAVY infusion:
|
|
- Infusion-related reactions are possible. Tell your healthcare provider right away if you get any of these symptoms during or a few days after your IMAAVY infusion:
|
|
Do not receive IMAAVY if you have a severe allergic reaction to nipocalimab-aahu or any of the ingredients in IMAAVY. Reactions have included angioedema and anaphylaxis.
Before using IMAAVY, tell your healthcare provider about all of your medical conditions, including if you:
- ever had an allergic reaction to IMAAVY.
- have or had any recent infections or symptoms of infection.
- have recently received or are scheduled to receive an immunization (vaccine). People who take IMAAVY should not receive live vaccines.
- are pregnant, plan to become pregnant, or are breastfeeding. It is not known whether IMAAVY will harm your baby.
Pregnancy Safety Study. There is a pregnancy safety study for IMAAVY if IMAAVY is given during pregnancy or you become pregnant while receiving IMAAVY. Your healthcare provider should report IMAAVY exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of IMAAVY?
IMAAVY may cause serious side effects. See "What is the most important information I should know about IMAAVY?"
The most common side effects of IMAAVY include: respiratory tract infection, peripheral edema (swelling in your hands, ankles, or feet), and muscle spasms.
These are not all the possible side effects of IMAAVY. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see the full Prescribing Information and Medication Guide for IMAAVY and discuss any questions you have with your doctor.
Dosage Form and Strengths: IMAAVY is supplied as a 300 mg/1.62 mL and a 1,200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection.
cp-509746v1
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 Research & Development, LLC, Janssen Biotech, Inc. and Janssen Global Services, LLC are Johnson & Johnson companies.
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 IMAAVY. 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.
REFERENCES
i Narayanaswami P, et al.International Consensus Guidance for Management of Myasthenia Gravis (2020 Update).Neurology. 2021;96:114‑122.Affirmed by the American Academy of Neurology Institute Board of Directors (July 14, 2022). [neurology.org]
ii Uzawa, A., Ozawa, Y., Yasuda, M. et al. Minimal symptom expression achievement over time in generalized myasthenia gravis. Acta Neurol Belg 123, 979–982 (2023). https://doi.org/10.1007/s13760-022-02162-1
iii Antozzi, C et al., Long-term Safety and Efficacy of Nipocalimab: Approximately 2 Years Follow-Up Results from the Open-Label Extension Phase of Vivacity-MG3 Study. Abstract #9.018 for poster presentation at 2026 American Academy of Neurology Congress. April 2026.
iv Vicente, E et al., Quality of Life in Patients with Generalized Myasthenia Gravis Achieving Sustained vs Transient Minimal Symptom Expression in the Phase 3 Vivacity-MG3 Trial. Abstract #9.007 for poster presentation at 2026 American Academy of Neurology Congress. April 2026.
v Wolfe GI Myasthenia gravis activities of daily living profile. Neurology. 1999;22;52(7):1487-9. doi: 10.1212/wnl.52.7.1487.
vi Yin J, et al. A multicenter, randomized, open-label, phase 2 clinical study of telitacicept in adult patients with generalized myasthenia gravis. Eur J Neurol. 2024 Aug;31(8):e16322. doi: 10.1111/ene.16322.
vii Burns TM, Conaway MR, Cutter GR, Sanders DB; Muscle Study Group. Less is more, or almost as much: a 15-item quality-of-life instrument for myasthenia gravis. Muscle Nerve. 2008 Aug;38(2):957-63
viii Antozzi, C et al., Efficacy and safety of nipocalimab in adults with generalised myasthenia gravis (Vivacity MG3): a randomised, double-blind, placebo-controlled phase 3 study. The Lancet Neurology. Feb 2025; 24: 105–16. https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(24)00498-8/fulltext
ix Chen J, Tian D-C, Zhang C, et al. Incidence, mortality, and economic burden of myasthenia gravis in
https://www.thelancet.com/action/showPdf?pii=S2666
x Bacci ED et al. Understanding side effects of therapy f or myasthenia gravis and their impact on daily life. BMC Neurol. 2019;19(1):335.
xi Wiendl, H., et al., Guideline f or the management of myasthenic syndromes. Therapeutic advances in
neurological disorders, 16, 17562864231213240. https://doi.org/10.1177/17562864231213240 Last
accessed: October 2025.
xii Bubuioc A, et al. The epidemiology of myasthenia gravis. Journal of Medicine & Life (2021). Jan-Mar;14(1):7-16. doi: 10.25122/jml-2020-0145.
xiii Ye, Yun et al. Epidemiology of myasthenia gravis in
xiv Dresser, Laura et al. Myasthenia Gravis: Epidemiology, Pathophysiology and Clinical Manifestations. Journal of clinical medicine vol. 10,11 2235. 21 May. 2021, doi:10.3390/jcm10112235.
xv J&J. Data on file.
xvi Evoli A, Batocchi AP, Bartoccioni E, Lino MM, Minisci C, Tonali P. Juvenile myasthenia gravis with prepubertal onset. Neuromuscul Disord. 1998 Dec;8(8):561-7. doi: 10.1016/s0960-8966(98)00077-7.
xvii Evoli A. Acquired myasthenia gravis in childhood. Curr Opin Neurol. 2010 Oct;23(5):536-40. doi: 10.1097/WCO.0b013e32833c32af.
xviii Finnis MF, Jayawant S. Juvenile myasthenia gravis: a paediatric perspective. Autoimmune Dis. 2011;2011:404101. doi: 10.4061/2011/404101.
xix Haliloglu G, Anlar B, Aysun S, Topcu M, Topaloglu H, Turanli G, Yalnizoglu D. Gender prevalence in childhood multiple sclerosis and myasthenia gravis. J Child Neurol. 2002 May;17(5):390-2. doi: 10.1177/088307380201700516.
xx Parr JR, Andrew MJ, Finnis M, Beeson D, Vincent A, Jayawant S. How common is childhood myasthenia? The
xxi Mansukhani SA, Bothun ED, Diehl NN, Mohney BG. Incidence and Ocular Features of Pediatric Myasthenias. Am J Ophthalmol. 2019 Apr;200:242-249. doi: 10.1016/j.ajo.2019.01.004.
xxii National Institute of Neurological Disorders and Stroke. Myasthenia Gravis. Available at: https://www.ninds.nih.gov/health-information/disorders/myasthenia-gravis Last accessed: October 2025.
xxiii Bever, C.T., Jr, Aquino, A.V., Penn, A.S., Lovelace, R.E. and Rowland, L.P. (1983), Prognosis of ocular myasthenia. Ann Neurol., 14: 516-519. https://doi.org/10.1002/ana.410140504
xxiv Kupersmith MJ, Latkany R, Homel P. Development of generalized disease at 2 years in patients with ocular myasthenia gravis. Arch Neurol. 2003 Feb;60(2):243-8. doi: 10.1001/archneur.60.2.243. PMID: 12580710.
xxv Myasthenia gravis fact sheet. Retrieved October 2025 from https://www.ninds.nih.gov/sites/default/files/ migrate-documents/myasthenia_gravis_e_march_2020_508c.pdf
xxvi Myasthenia Gravis: Treatment & Symptoms. (2021, April 7). Retrieved October 2025 from https://my.clevelandclinic.org/health/diseases/17252-myasthenia-gravis-mg.
xxvii DRG EPI (2021) & Optum Claims Analysis Jan 2012-December 2020.
xxviii O'Connell K, Ramdas S, Palace J. Management of Juvenile Myasthenia Gravis. Front Neurol. 2020 Jul 24;11:743. doi: 10.3389/fneur.2020.00743. PMID: 32793107; PMCID: PMC7393473.
xxix Antozzi, C et al., Efficacy and safety of nipocalimab in adults with generalised myasthenia gravis (Vivacity MG3): a randomised, double-blind, placebo-controlled phase 3 study. The Lancet Neurology. Feb 2025; 24: 105–16. https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(24)00498-8/fulltext
xxx ClinicalTrials.gov Identifier: NCT04951622. Available at: https://clinicaltrials.gov/ct2/show/NCT04951622 Last accessed: October 2025.
xxxi IMAAVY U.S. Prescribing Information.
xxxii ClinicalTrials.gov. NCT03842189. Available at: https://clinicaltrials.gov/ct2/show/NCT03842189. Last accessed: October 2025.
xxxiii ClinicalTrials.gov Identifier: NCT05327114. Available at: https://www.clinicaltrials.gov/study/NCT05327114. Last accessed: October 2025.
xxxiv ClinicalTrials.gov Identifier: NCT04119050. Available at: https://clinicaltrials.gov/study/NCT04119050. Last accessed: October 2025.
xxxv ClinicalTrials.gov Identifier: NCT05379634. Available at: https://clinicaltrials.gov/study/NCT05379634. Last accessed: October 2025
xxxvi ClinicalTrials.gov Identifier: NCT05912517. Available at: https://www.clinicaltrials.gov/study/NCT05912517. Last accessed: October 2025.
xxxvii ClinicalTrials.gov Identifier: NCT04968912. Available at: https://clinicaltrials.gov/study/NCT04968912. Last accessed: October 2025.
xxxviii ClinicalTrials.gov Identifier: NCT04882878. Available at: https://clinicaltrials.gov/study/NCT04882878. Last accessed: October 2025.
xxxix ClinicalTrials.gov Identifier: NCT06449651. Available at: https://clinicaltrials.gov/study/NCT06449651. Last accessed: October 2025.
xl ClinicalTrials.gov Identifier: NCT06533098. Available at: https://clinicaltrials.gov/study/NCT06533098. Last accessed: October 2025.
Media contact: Brianna Davis | Investor contact: Jessica Margevich |
View original content to download multimedia:https://www.prnewswire.com/news-releases/imaavy-nipocalimab-aahu-shows-over-two-years-of-sustained-disease-control-in-a-broad-population-with-generalized-myasthenia-gravis-gmg-302749496.html
SOURCE Johnson & Johnson