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Johnson & Johnson (J&J) has received approval from the US Food and Drug Administration for its FcRn blocker Imaavy (nipocalimab-aahu) in generalised myasthenia gravis (gMG). The drug has been authorised to treat the rare autoimmune disease in adults and paediatric patients aged 12 years and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive. In myasthenia gravis, autoantibodies target proteins at the neuromuscular junction, disrupting the ability of the nerves to stimulate the muscles. The disease affects an estimated 700,000 people worldwide, with 85% of these patients experiencing the more extensive form of the disease, gMG. J&J’s Imaavy is designed to block FcRn and reduce levels of circulating immunoglobulin G antibodies that underlie gMG. The FDA’s decision on the drug was based on results from the phase 3 Vivacity-MG3 study, in which adult gMG patients receiving Imaavy plus standard of care achieved superior disease control throughout 24 weeks, as measured by improvements in the MG-ADL score, compared to those randomised to receive placebo plus standard of care. Data from an ongoing open-label extension phase of the trial showed that patients in the Imaavy cohort maintained improvements out to 20 months of follow-up, J&J said, adding that Imaavy was associated with a “rapid and sustained” reduction in autoantibody levels by up to 75% from the first dose and throughout a 24-week period of monitoring. Positive results from the ongoing phase 2/3 Vibrance in anti-AChR and anti-MuSK antibody-positive patients aged 12 to 17 years also supported the authorisation. David Lee, global immunology therapeutic area head, J&J Innovative Medicine, said: “This approval is the result of years of scientific commitment, collaboration and determination for our nipocalimab programme, and we’re proud to bring this new treatment option to patients living with anti-AChR or anti-MuSK antibody positive gMG.” Beyond gMG, nipocalimab is being evaluated across three key segments in the autoantibody space: rare autoantibody diseases, rheumatic diseases and certain maternal foetal diseases. The drug has already received several key designations by the FDA, including breakthrough therapy designation as a treatment for adults with moderate-to-severe cases of the chronic autoimmune disorder, Sjögren’s disease.

New compelling results demonstrate 18 months of both sustained reduction in immunoglobulin G antibodies and sustained improvement in gMG symptoms in pivotal Vivacity-MG3 study and open-label extension phase Up to 128 weeks and 180 patient years of follow-up in the open-label extensiona confirm a safety profile consistent with the Phase 3 Vivacity-MG3 study 45% of the patients receiving steroids at open-label extension baseline were able to decrease or discontinue their steroid use Additionally, the nipocalimab plus standard of care (SOC) group demonstrated four times greater odds of improving and maintaining the strength and function of different muscle groups as measured by QMGb response versus placebo plus SOC in the 24-week double blind phase of the study SPRING HOUSE, Pa., April 8, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced results from additional analyses of the Phase 3 Vivacity-MG3 double-blind study and the ongoing open-label extensiona (OLE), evaluating the long-term efficacy and safety of investigational nipocalimab in a broad population of antibody-positive (anti-AChR+, anti-MuSK+, anti-LRP4+) adults with generalized myasthenia gravis (gMG).1,2 Patients treated with nipocalimab plus standard of care (SOC) maintained improvements in their MG-ADLc and QMGb scores over 84 weeks with sustained reductions in total immunoglobulin G (IgG).1 These data are included in a presentation (Session 7 #022) and are among 12 abstracts that Johnson & Johnson will present at the American Academy of Neurology (AAN) 2025 Meeting in San Diego, California, which includes an oral presentation on QMG score improvements from the double-blind phase of the Phase 3 Vivacity-MG3 study. "The sustained disease control seen over 84 weeks for nipocalimab is a key result given the chronic course of generalized MG and the significant burden on people living with this condition," said Constantine Farmakidis M.D., Associate Professor of Neurology at University of Kansas Medical Centerd. "Overall, I am encouraged by these results that show improvement in disease control as measured by the MG-ADL and QMG scores across a broad population seropositive for AChR, MuSK, or LRP4 autoantibodies." Nipocalimab demonstrated a mean change in MG-ADL of -5.64 (p<0.001) from the double-blind baseline after 60 weeks in the OLE for study participants receiving nipocalimab and SOC, and -6.01 (p<0.001) mean change for study participants who transitioned from placebo and SOC to nipocalimab and SOC.1 In the antibody-positive population, 45% of patients receiving steroids at the OLE baseline were able to decrease or discontinue steroids at the time of this data cut by more than half of the baseline dose.1 Among these patients, the mean dose of prednisone decreased from 23 to 10 mg per day.1 Nipocalimab had a consistent and tolerable safety profile throughout the OLE phase.1 Additional findings from the Phase 3 Vivacity-MG3 double-blind study indicate that patients treated with nipocalimab plus SOC achieved statistically significant improvements in their QMG score by -4.9 versus placebo plus SOC (p<0.001) over weeks 22 and 24.2 Patients in the nipocalimab plus SOC treatment group were four times more likely to sustain symptom improvement at 20 weeks compared to the placebo plus SOC group, as measured by a three or greater point improvement on the QMG score.2 Results show significantly more patients treated with nipocalimab (36.4%,) versus placebo (10.5%, p<0.001) spent greater than 75% of study duration demonstrating improvements in the QMG score.2 A reduction of more than three points in the QMG score indicates a decrease in the severity of the patient's symptoms as a result of improvements in muscle strength, allowing patients to carry out important daily activities such as swallowing and chewing.3,4 "People living with generalized MG around the world endure daily challenges, such as difficulties swallowing, impaired speech and muscle weakness. They deserve additional, effective treatment options that help address these challenges and provide sustained disease control and stability over time," said Katie Abouzahr, M.D., Vice President, Autoantibody Portfolio and Maternal Fetal Immunology Disease Area Leader, Johnson & Johnson Innovative Medicine. "These positive data underscore our commitment to helping develop potential innovative therapeutic options for patients living with autoantibody diseases, including gMG." Editor's notes: 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] or anti-low density lipoprotein-related protein 4 [LRP4]), which target proteins at the neuromuscular junction, and can block or disrupt normal signaling from nerves to muscles, thus impairing or preventing muscle contraction.5,6,7 The disease impacts an estimated 700,000 people worldwide.5 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.8 Roughly 50 percent of individuals diagnosed with MG are women, and about one in five of those women are of child-bearing potential.9,10,11 Approximately 10 to 15% of new cases of MG are diagnosed in adolescents (12 – 17 years of age).12,13,14 Among juvenile MG patients, girls are affected more often than boys with over 65% of pediatric MG cases in the U.S. diagnosed in girls.15,16,17 Initial disease manifestations are usually ocular, but 85 percent of MG patients experience additional advancements to the disease manifestations – referred to as generalized myasthenia gravis (gMG). This is characterized by severe muscle weakness of the skeletal muscles and difficulties in speech and swallowing.18,19,20,21,22 Approximately 100,000 individuals in the U.S. are living with gMG.23 Vulnerable gMG populations, such as pediatric patients, have more limited therapeutic options.24 Currently, SOC treatments for adolescents with gMG are extrapolated from adult trials.14 Other than symptomatic treatments, there are no approved FcRn blockers for adolescents with gMG in the United States.14 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.25,26 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.25 Baseline demographics were balanced across arms (77 nipocalimab, 76 placebo).25 The primary endpoint of the study was mean change in MG-ADLb score from baseline over Weeks 22, 23 and 24 in antibody positive patients. A key secondary endpoint included change in QMG score. Long-term safety and efficacy were further assessed in an ongoing open-label extension (OLE) phase.26 ABOUT NIPOCALIMAB 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. This includes autoantibodies and alloantibodies that underlie multiple conditions across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Fetal diseases mediated by maternal alloantibodies and Rheumatic diseases.26,27,28,29,30,31,32,33,34 Blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus.35,36 The U.S. FDA and EMA have granted several key designations to nipocalimab including: 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 and fetal neonatal alloimmune thrombocytopenia (FNAIT) in March 2024 and Sjögren's disease (SjD) in March 2025 U.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 2023 U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for Sjögren's disease in November 2024 U.S. FDA granted Priority Review in gMG in Q4 2024 EU EMA Orphan medicinal product designation for HDFN in October 2019 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 or at Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. 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 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 Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or 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 , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. 1 Antozzi, C et al., Long-Term Safety and Efficacy of Nipocalimab in Generalized Myasthenia Gravis: Vivacity-MG3 Open-Label Extension Phase Results. Abstract #022 for poster presentation at 2025 American Academy of Neurology Congress. April 2025. 2 Nowak R et al., Efficacy of Nipocalimab, a Novel Neonatal Fragment Crystallizable Receptor Blocker, as Measured using Quantitative Myasthenia Gravis Assessment: Findings from the Phase 3 Placebo-Controlled Vivacity-MG3 Study. Abstract #001 for oral presentation at 2025 American Academy of Neurology Congress. April 2025. 3 Wolfe GI Myasthenia gravis activities of daily living profile. Neurology. 1999;22;52(7):1487-9. doi: 10.1212/wnl.52.7.1487. 4 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. 5 Chen J, Tian D-C, Zhang C, et al. Incidence, mortality, and economic burden of myasthenia gravis in China: A nationwide population-based study. The Lancet Regional Health - Western Pacific. 2020;5(100063). . 6 Bacci ED et al. Understanding side effects of therapy for myasthenia gravis and their impact on daily life. BMC Neurol. 2019;19(1):335. 7 Wiendl, H., et al., Guideline for the management of myasthenic syndromes. Therapeutic advances in neurological disorders, 16, 17562864231213240. . Last accessed: April 2025. 8 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. 9 Ye, Yun et al. Epidemiology of myasthenia gravis in the United States. Frontiers in neurology vol. 15 1339167. 16 Feb. 2024, doi:10.3389/fneur.2024.1339167. 10 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. 11 J&J. Data on file. 12 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. 13 Evoli A. Acquired myasthenia gravis in childhood. Curr Opin Neurol. 2010 Oct;23(5):536-40. doi: 10.1097/WCO.0b013e32833c32af. 14 Finnis MF, Jayawant S. Juvenile myasthenia gravis: a paediatric perspective. Autoimmune Dis. 2011;2011:404101. doi: 10.4061/2011/404101. 15 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. 16 Parr JR, Andrew MJ, Finnis M, Beeson D, Vincent A, Jayawant S. How common is childhood myasthenia? The UK incidence and prevalence of autoimmune and congenital myasthenia. Arch Dis Child. 2014 Jun;99(6):539-42. doi: 10.1136/archdischild-2013-304788. 17 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. 18 National Institute of Neurological Disorders and Stoke. Myasthenia Gravis. Available at: . Last accessed: April 2025. 19 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. . 20 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. 21 Myasthenia gravis fact sheet. Retrieved April 2024 from . 22 Myasthenia Gravis: Treatment & Symptoms. (2021, April 7). Retrieved April 2024 from . 23 DRG EPI (2021) & Optum Claims Analysis Jan 2012-December 2020. 24 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. 25 Antozzi, C et al., Nipocalimab in Generalized Myasthenia Gravis: Results from a Double-Blind, Placebo-Controlled, Randomized Phase 3 Study. Abstract at 2024 European Academy of Neurology Congress. June 2024. 26 ClinicalTrials.gov Identifier: NCT04951622. Available at: . Last accessed: April 2025. 27 ClinicalTrials.gov. NCT03842189. Available at: . Last accessed: April 2025. 28 ClinicalTrials.gov Identifier: NCT05327114. Available at: . Last accessed: April 2025. 29 ClinicalTrials.gov Identifier: NCT04119050. Available at: . Last accessed: April 2025. 30 ClinicalTrials.gov Identifier: NCT05379634. Available at: . Last accessed: April 2025. 31 ClinicalTrials.gov Identifier: NCT05912517. Available at: . Last accessed: April 2025. 32 ClinicalTrials.gov Identifier: NCT06028438. Available at: . Last accessed: April 2025. 33 ClinicalTrials.gov Identifier: NCT04968912. Available at: . Last accessed: April 2025. 34 ClinicalTrials.gov Identifier: NCT04882878. Available at: . Last accessed: April 2025. 35 Lobato G, Soncini CS. Relationship between obstetric history and Rh(D) alloimmunization severity. Arch Gynecol Obstet. 2008 Mar;277(3):245-8. DOI: 10.1007/s00404-007-0446-x. 36 Roy S, Nanovskaya T, Patrikeeva S, et al. M281, an anti-FcRn antibody, inhibits IgG transfer in a human ex vivo placental perfusion model. Am J Obstet Gynecol. 2019;220(5):498 e491-498 e499. SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ADAPT-NXT data demonstrate consistent, sustained disease control across dosing schedules, further supporting individualized VYVGART dosing for gMG patients ADHERE+ oral presentation features long-term CIDP data demonstrating VYVGART Hytrulo’s durable efficacy, sustained functional improvements and favorable safety profileargenx continues to advance a robust neuromuscular pipeline of clinical candidates; first-in-human data of ARGX-119 (MuSK agonist) support pipeline-in-a-product development plan April 8, 2025, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced the presentation of 15 abstracts, including an oral presentation, at the 2025 American Academy of Neurology (AAN) Annual Meeting from April 5 – 9, 2025 in San Diego, CA. The presentations showcase long-term data of VYVGART® (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) demonstrating sustained disease control of generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) with a favorable safety profile. argenx also highlighted its commitment to reach the broader MG patient community with two ongoing label expansion studies in ocular myasthenia gravis (oMG) and seronegative MG (snMG). In addition, first-in-human data were presented for the company’s third clinical candidate, ARGX-119 (MuSK agonist), which is being evaluated in disorders of the neuromuscular junction (NMJ), including congenital myasthenic syndromes (CMS). “The data presented at AAN underscore VYVGART and VYVGART Hytrulo’s differentiated efficacy and safety profile, connecting data from our long-term studies to what matters most to gMG and CIDP patients, which is durable, significant quality of life improvements,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. “The extensive data from ADAPT-NXT reinforce the sustained efficacy in patients living with gMG and showcase the opportunity of individualized VYVGART treatment across fixed cycles or every two- or three-week dosing. Also, our long term ADHERE+ data highlight the strength of VYVGART Hytrulo to meaningfully impact motor function and muscle strength for patients with CIDP. Overall, the data we are sharing at AAN reinforce our commitment to the neuromuscular community and further solidify VYVGART as a leading biologic to redefine patient outcomes.” VYVGART Sets New Benchmark of Sustained Efficacy and Safety for Patients with gMG Sustained disease control achieved across multiple dosing approaches: ADAPT-NXT Part B data demonstrate clinically meaningful improvements as early as Week 1 with both bi-weekly and every three-week dosing schedules of VYVGART. Over the course of the study (126 weeks), 75% of patients showed sustained efficacy, achieving 2-points or more of improvement in MG activities of daily living (MG-ADL score) during more than 75% of study visits. In addition, more than half (56.5%) of participants achieved minimal symptom expression (MSE) during the study. ADAPT NXT data support multiple options to individualize treatment for patients living with gMG. (Poster P1.004)Consistent efficacy and safety results over nine treatment cycles: Interim results of ADAPT-SC+ demonstrate consistent and repeatable improvements in MG-ADL and MG Quality of Life (MG-QoL) scores in gMG patients treated with VYVGART Hytrulo. There was no observed increase in infections or injection-site reactions over nine cycles of treatment. Also, the proportion of patients able to achieve MSE was consistent across multiple cycles. (Poster P1.005) VYVGART Hytrulo Delivers Long-term Functional Improvements and Favorable Safety Profile for Patients with CIDP Significant functional improvements and rapid stabilization: ADHERE+ data demonstrate VYVGART Hytrulo delivers long-term clinical efficacy. Study results report functional improvements across aINCAT disability scores (>1-point), grip strength (>17 kPa) and I-RODS scale (>8 points) at week 36 compared to baseline at entry to standard of care withdrawal phase. In addition, the majority of ADHERE patients who relapsed during randomized treatment withdrawal stage, restabilized on VYVGART – 50% as early as week 4. Treatment-emergent adverse events (TEAEs) were consistent with label and no new events, nor increased rate or severity of TEAEs were reported with longer treatment with VYVGART Hytrulo. (Oral Presentation S16.002)Real-world insights on transitioning from IVIg to VYVGART Hytrulo: The ADHERE Phase 4 switch open-label study will build upon the ADHERE registrational trial with new data evaluating the transition of patients from a stable dose of IVIg to VYVGART Hytrulo in a one-week transition period (Poster P10.026). Currently, real-world data of 1,316 CIDP patients (as of Jan. 31, 2025) treated with VYVGART Hytrulo show that 3.3% of patients reported any general CIDP worsening. (Symposium: ITU From Discovery to Practice: FcRn Blockade and its Role in CIDP and gMG) Pipeline Targets Unmet Needs in Underserved Patient Communities First-in-human Phase 1 study supports continued investigation of ARGX-119: Across multiple and single dosing regimens, data from ARGX-119 show a favorable safety profile with no new safety signals observed, supporting further development as a treatment for patients with disorders of the NMJ. (Poster P10.007)Expansion to Seronegative and Ocular MG: argenx is pursuing label extension for VYVGART to broaden its impact with the MG community, including through two Phase 3 studies for seronegative gMG (ADAPT-SERON) and ocular MG (ADAPT-OCULUS). The ADAPT-SERON study is supported by data from seronegative patients in prior VYVGART studies showing consistent and clinically meaningful MG-ADL improvements, including patients achieving MSE. (Poster P1.029) Full study details can be found at 2025 American Academy of Neurology Abstract Website See FDA-approved Important Safety Information below, full Prescribing Information for VYVGART, and full Prescribing Information for VYVGART Hytrulo for additional information. Important Safety Information What is VYVGART® (efgartigimod alfa-fcab)?VYVGART is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive). IMPORTANT SAFETY INFORMATIONDo not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. VYVGART can cause serious allergic reactions and a decrease in blood pressure leading to fainting. VYVGART may cause serious side effects, including: Infection. VYVGART may increase the risk of infection. The most common infections were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.Allergic Reactions (hypersensitivity reactions). VYVGART can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with VYVGART. Infusion-Related Reactions. VYVGART can cause infusion-related reactions. The most frequent symptoms and signs reported with VYVGART were high blood pressure, chills, shivering, and chest, abdominal, and back pain. Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction. Before taking VYVGART, tell your doctor if you: take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,have received or are scheduled to receive a vaccine (immunization), orhave any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding. What are the common side effects of VYVGART?The most common side effects of VYVGART are respiratory tract infection, headache, and urinary tract infection. These are not all the possible side effects of VYVGART. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088. Please see the full Prescribing Information for VYVGART and talk to your doctor. What is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)?VYVGART HYTRULO is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).VYVGART HYTRULO is a prescription medicine used for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) IMPORTANT SAFETY INFORMATIONDo not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting. VYVGART HYTRULO may cause serious side effects, including: Infection. VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.Allergic Reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab. Infusion-Related Reactions. VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain. Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction. Before taking VYVGART HYTRULO, tell your doctor if you: take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,have received or are scheduled to receive a vaccine (immunization), or have any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding. What are the common side effects of VYVGART HYTRULO?The most common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives. These are not all the possible side effects of VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088. Please see the full Prescribing Information for VYVGART HYTRULO and talk to your doctor. About VYVGART and VYVGART HytruloVYVGART® (efgartigimod alfa fcab) is a first-in-class human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. VYVGART® Hytrulo is a subcutaneous combination of efgartigimod alfa (VYVGART) and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology, which facilitates subcutaneous injection delivery of biologics. VYVGART is approved for generalized myasthenia gravis (gMG) and immune thrombocytopenia (Japan only). VYVGART Hytrulo is approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo may be marketed under different proprietary names in other regions. About ARGX-119 ARGX-119 is a humanized agonistic monoclonal antibody (mAb) that targets and activates muscle-specific kinase (MuSK) to promote maturation and stabilization of the neuromuscular junction (NMJ). MuSK is a receptor kinase that has a critical role in the structure and function of the NMJ. ARGX-119 is being developed as a potential therapy for patients with neuromuscular disease. About Generalized Myasthenia Gravis (gMG)Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months¹, where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population. About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare and serious autoimmune disease of the peripheral nervous system. Although confirmation of disease pathophysiology is still emerging, there is increasing evidence that IgG antibodies play a key role in the damage to the peripheral nerves. People with CIDP experience fatigue, muscle weakness and a loss of feeling in their arms and legs that can get worse over time or may come and go. These symptoms can significantly impair a person's ability to function in their daily lives. Without treatment, one-third of people living with CIDP will need a wheelchair. About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, X/Twitter, Instagram, Facebook, and YouTube. References1 Behin et al. New Pathways and Therapeutics Targets in Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277 For further information, please contact: Media: Colin McBeancmcbean@argenx.com Investors: Alexandra Roy (US) aroy@argenx.com Lynn Elton (EU) lelton@argenx.com Forward-looking Statements The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “aim,” “are,” “believe,” “can,” “continue,” “expect,” “may,” and “will” and include statements argenx makes concerning the potential impact of VYVGART, VYVGART Hytrulo and ARGX-119 for patients; the data for VYVGART, VYVGART Hytrulo and ARGX-119 as well as clinical studies, including ADAPT-NXT and ADHERE+; its commitment to reach the broader MG patient community with two ongoing label-expansion in oMG and snMG; its commitment to improve the lives of people suffering from severe autoimmune diseases; its goal to continue to advance a robust neuromuscular pipeline of clinical candidates; its view that first-in-human data of ARGX-119 support pipeline-in a-product development plan; the ability for ADAPT-NEXT to reinforce the sustained efficacy in patients living with gMG and showcase the opportunity of individualized VYVGART treatment; the ability of VYVGART Hytrulo to meaningfully impact motor function and muscle strength for patients with CIDP; its commitment to the neuromuscular community; its commitment to further solidify VYVGART as a leading biologic to redefine patient outcomes; its expectations regarding the ADHERE Phase 4 switch open-label study; its aim to target unmet needs in underserved patient communities; and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. 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