A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease Inadequately Controlled With Antithyroid Drugs

The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated. It will look at how efgartigimod is distributed and eliminated in the body, how it changes antibody levels, and how the immune system responds to it.
The study consists of a part A double-blinded treatment period, a part B treatment/observation period and a part C open-label treatment/observation period. During the part A and part B treatment periods, participants will receive efgartigimod PH20 SC via Prefilled Syringe (PFS) or placebo. During the part C open-label treatment period, participants will receive efgartigimod PH20 SC PFS. Participation in the different parts of the study will depend on the participant's response to treatment.
The total study duration for participants ranges from 63 to 135 weeks, depending on the response to treatment.

Start Date01 Jun 2026

Sponsor / Collaborator

argenx SE

NCT07264426

/ RecruitingNot Applicable

Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study

The aims of this study are to assess the real-world effectiveness of efgartigimod in treating chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), describe the "treatment journey" of participants with CIDP, and assess the utilization of health care services among adult participants with CIDP who initiate treatment with efgartigimod.
As this is a noninterventional study, treatment choices and decisions will be left to the discretion of participants and their physicians, according to the standard of care.
Each participant will be prospectively followed for up to 2 years from the date of initial administration of efgartigimod.

Start Date11 Aug 2025

Sponsor / Collaborator

argenx SE

JPRN-jRCT2071250042

/ RecruitingPhase 2IIT

A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter, Investigator-Initiated Study to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Primary Sjogren's Disease-Associated Dryness Symptoms

Start Date01 Aug 2025

Sponsor / Collaborator-

100 Clinical Results associated with Efgartigimod/Hyaluronidase

100 Translational Medicine associated with Efgartigimod/Hyaluronidase

100 Patents (Medical) associated with Efgartigimod/Hyaluronidase

Literatures (Medical) associated with Efgartigimod/Hyaluronidase

01 Aug 2026·JOURNAL OF NEUROIMMUNOLOGY

Real-world experience with switching from intravenous immunoglobulin to subcutaneous efgartigimod PH20 in patients with chronic inflammatory demyelinating polyradiculoneuropathy: A case series

Article

Author: Govindarajan, Raghav

INTRODUCTION/AIMS:

In the ADHERE trial (NCT04281472), subcutaneous (SC) efgartigimod PH20 provided clinical benefit in participants with worsening chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), regardless of prior CIDP treatment, including intravenous immunoglobulin (IVIg). Real-world data for efgartigimod PH20 SC treatment, which would not require worsening CIDP, are limited.

METHODS:

This is a case series of four patients diagnosed with typical CIDP between 3 and 12 months before start of study, who switched from IVIg (1 g/kg every 4 weeks) to efgartigimod PH20 SC (1000 mg weekly).

RESULTS:

Mean age was 59.3 years. At IVIg start, mean lower limb/upper limb (LL/UL) Inflammatory Neuropathy Cause and Treatment (INCAT) scores were 3.5/2.3 (range: 3-4/2-3), and Medical Research Council (MRC) sum score was 41.0 (range: 36-44). Despite early improvements in INCAT (mean LL/UL, 2.5/1.3 [range: 2-3/1-2]) and MRC (mean 47.5 [range: 42-54]) scores with IVIg, only one patient received IVIg for 6 months; three experienced unfavorable side effects, and one switched for convenience reasons. At the start of efgartigimod PH20 SC treatment, mean LL/UL INCAT scores were 2.3/1.3 (range: 2-3/1-2) and MRC sum score was 49.0 (range: 42-54); after 6 months, there were slight improvements in INCAT (mean LL/UL, 2.0/1.0 [range: 2-2/1-1]) and MRC (mean 51.5 [range: 48-54]) scores. Side effects were minimal in three patients and were not experienced by one patient.

DISCUSSION:

These results suggest that patients with CIDP being treated with IVIg can benefit from switching to efgartigimod PH20 SC treatment.

01 Jul 2026·JOURNAL OF THE NEUROLOGICAL SCIENCES

Diagnostic adjudication of potential participants with chronic inflammatory demyelinating polyradiculoneuropathy in the ADHERE trial of subcutaneous efgartigimod PH20

Article

Author: Kostera-Pruszczyk, Anna ; Karam, Chafic ; Nobile-Orazio, Eduardo ; Léger, Jean-Marc ; De Roeck, Arne ; Kira, Jun-Ichi ; Attarian, Shahram ; Hofman, Erik ; Donofrio, Peter D ; Tse, Anissa ; Gorson, Kenneth C ; Lewis, Richard A ; Markov, Martin

BACKGROUND:

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a rare, acquired, immune-mediated polyneuropathy that is commonly misdiagnosed. The global, pivotal ADHERE trial pioneered the use of a diagnostic adjudication committee (DAC) to verify accurate CIDP diagnosis for potential participants.

METHODS:

The committee consisted of nine independent experts with extensive experience in CIDP diagnosis, trained to review existing evidence for CIDP in patient medical records. Enrollment eligibility was confirmed when 2 of 2 adjudicators agreed on a definite or probable CIDP diagnosis, as defined by the 2010 European Federation of Neurological Societies-Peripheral Nerve Society criteria (2/2 agreement; phase 1). Participants were not enrolled if both adjudicators determined that the eligibility criteria were not met. When the two adjudicators disagreed, a third adjudicator (the DAC Chair or designee) provided a 2 out of 3 majority vote (phase 2).

RESULTS:

Of the 560 cases reviewed, 391/560 (69.8%) were determined to have definite/probable CIDP and 169/560 (30.2%) did not meet diagnostic eligibility for ADHERE. Of all enrolled participants with phase 1 adjudication data (n = 340), 277 (81.5%) were confirmed with a 2/2 agreement on diagnostic eligibility (phase 1); 50 participants who were determined to have definite/probable CIDP failed other inclusion/exclusion criteria and were not eligible for ADHERE. The top reasons for disagreement between adjudicators in phase 1 were differences in assessment of clinical and electrodiagnostic criteria.

CONCLUSION:

Use of a DAC addressed the limitation of CIDP misdiagnosis and increased the likelihood that the ADHERE trial included participants with confirmed CIDP.

01 Jan 2026·Journal of Clinical Neurology

Efficacy, Safety, and Tolerability of Subcutaneous Efgartigimod PH20 in Chinese Patients With Chronic Inflammatory Demyelinating Polyneuropathy: A Prespecified Subpopulation Analysis of the Multicentre, Randomised-Withdrawal, Double-Blind, Placebo-Controlled, Phase II ADHERE Trial

Article

Author: Ding, Jing ; Guo, Aihong ; Zhao, Yuanqi ; Jiang, Haishan ; Hofman, Erik ; Zou, Zhangyu ; Lu, Zuneng ; Liu, Jing ; Shao, Jing ; Liu, Jia ; Wang, Qinzhou ; Guo, Junhong ; Hoorick, Benjamin Van ; Wu, Junlong ; Chang, Ting ; Hong, Daojun ; Lin, Jie ; He, Dian ; Chen, Lijuan ; Bu, Bitao ; Liang, Hui ; Shi, Jianquan ; Li, Wei ; Tan, Song ; Wang, Yiqi ; Yang, Huan ; Ding, Man ; Zhang, Yali ; Da, Yuwei ; Mole, Trevor ; Wang, Yuzhong

BACKGROUND AND PURPOSE:

Efgartigimod, a neonatal Fc receptor inhibitor, reduces IgG recycling and thus decreases pathogenic IgG autoantibody levels. This subpopulation analysis aimed to assess the efficacy, safety, and tolerability of subcutaneous efgartigimod PH20 in Chinese participants with chronic inflammatory demyelinating polyneuropathy (CIDP).

METHODS:

ADHERE was a multistage, randomised-withdrawal, placebo-controlled phase II trial in adult participants with active CIDP. Eligible participants received open-label treatment with efgartigimod weekly for ≤12 weeks (Stage A) and those with confirmed evidence of clinical improvement (ECI) were randomised to receive double-blind treatment with efgartigimod or placebo weekly for ≤48 weeks (Stage B). Primary endpoints were proportion of participants with confirmed ECI (Stage A) and time to clinical deterioration as measured by adjusted Inflammatory Neuropathy Cause and Treatment score (Stage B). This descriptive analysis reports the results from the Chinese subpopulation.

RESULTS:

ADHERE enrolled 58 participants from mainland China for Stage A and of those, 47 were randomised (21 efgartigimod, 26 placebo) for Stage B. In Stage A, 45 (77.6%; 95% confidence interval [CI], 64.7%-87.5%) participants achieved confirmed ECI. In Stage B, median time to clinical deterioration was not reached with efgartigimod vs. 113.0 days (95% CI, 43.0-181.0 days) with placebo (hazard ratio, 0.313; 95% CI, 0.109-0.905). Across stages, most adverse events were mild or moderate, and no death occurred. No adverse events led to treatment discontinuation.

CONCLUSIONS:

Subcutaneous efgartigimod PH20 demonstrated clinical response and lowered the risk of clinical deterioration compared to placebo in Chinese participants with CIDP, while maintaining favourable safety and tolerability profiles.

128

News (Medical) associated with Efgartigimod/Hyaluronidase

03 Jun 2026

·www.biospace.com

argenx Presents New Efgartigimod Data Showing Long-Term Sustained Patient Benefit in Myositis and Sjogren’s Disease at EULAR 2026

ALKIVIA+ data in myositis indicate efgartigimod provides sustained, clinically meaningful improvements and consistent safety RHO+ data in Sjogren’s disease indicate maintenance of response following switch to biweekly dosing Cross-indication analysis of efgartigimod data across rheumatology studies underscores consistent safety pro large patient population June 3, 2026, 7:00 AM CEST 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 new data evaluating VYVGART® (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) across autoimmune rheumatic diseases, including myositis and Sjogren’s disease, to be presented at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress from June 3-6, 2026, in London, UK. “Our presentations at EULAR further support the rationale for targeting FcRn in autoimmune rheumatic diseases and underscore its potential to address significant unmet patient need,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. “We are encouraged by the consistency of the long-term data as well as data underscoring efgartigimod's favorable safety pro multiple autoimmune rheumatic diseases. We are looking forward to additional results evaluating efgartigimod in myositis later this year as well as in Sjogren’s disease next year.” Myositis and Sjogren’s disease are both chronic, progressive autoimmune diseases that are generally more common in women than men. Myositis can cause serious and irreversible damage to muscles and organs, leading to a loss of independence and a significant burden for patients. Sjogren’s disease can cause dry eyes and mouth, chronic fatigue, and joint pain. It can also affect multiple organ systems and lead to nervous system complications. Efgartigimod provides sustained functional improvement in patients with myositis ALKIVIA+ is an ongoing open-label extension study that enrolled patients who completed the 24-week, double-blind, placebo-controlled Phase 2 ALKIVIA trial, including those who continued efgartigimod treatment and those who transitioned from placebo to efgartigimod. Results presented at EULAR are an interim analysis through Week 52. A key metric in ALKIVIA+ is Total Improvement Score (TIS). TIS is a composite index based on six core set measures, including muscle strength, physician and patient global assessments of disease activity, physical function, enzyme levels, and extramuscular activity. Higher TIS values reflect greater overall clinical improvement. Moderate and major improvement are defined as TIS ≥40 and ≥60, respectively. Results showed: At 52 weeks, 37.5% of patients who had continuously received efgartigimod maintained their major TIS improvement from week 24. 33.3% of patients switching from placebo to efgartigimod achieved a similar major TIS improvement. Rates of moderate TIS improvement were also similar between the groups, at 75.0% and 66.7%, respectively. Sustained mean TIS benefit: Patients receiving continuous efgartigimod maintained clinically meaningful improvement through 52 weeks, with a mean TIS of 52.19. Patients who switched from placebo to efgartigimod achieved comparable improvement, with a mean TIS of 49.62 at week 52. The safety pro consistent over the course of the study, with no increase in adverse events with longer exposure. These results further support the mechanistic relevance of FcRn blockade in myositis, providing further evidence that pathogenic autoantibodies are the underlying driver of disease. “Patients with autoimmune myositis face the serious challenge that their immune system attacks their own body, causing irreversible muscle loss, weakness, pain and reduced quality of life, while the limited available treatments can carry significant side effects and be difficult to tolerate long term,” said Hector Chinoy, M.D., Ph.D., presenting study author and Professor of Rheumatology and Neuromuscular Disease at The University of Manchester. “Emerging results from the ALKIVIA+ study suggest that efgartigimod has the potential to deliver meaningful and sustained clinical benefit for patients with myositis, with a favorable tolerability profile.” Topline results from the Phase 3 ALKIVIA study are expected in the third quarter of 2026. Efgartigimod achieved maintenance of response in Sjogren’s disease RHO+, a 48-week open-label extension study, evaluated patients with Sjogren's disease who continued to receive efgartigimod, and those who transitioned from placebo to efgartigimod after completing the 24-week double-blind treatment period of the Phase 2 RHO study. Response to efgartigimod was assessed using the Composite of Relevant Endpoints for Sjogren’s Syndrome (CRESS), a composite endpoint designed to capture overall treatment benefit across multiple clinical domains, including disease activity as measured by ClinESSDAI. Patients in the efgartigimod arm were switched to biweekly dosing based on ClinESSDAI response. Results showed: Patients in the efgartigimod arm switching to biweekly dosing experienced maintenance of response on clinical measures. Patients in the placebo arm switching to efgartigimod experienced improvements in ClinESSDAI and increased CRESS response. At week 72, median ClinESSDAI scores were low in both groups: 2.5 in the efgartigimod arm and 2.0 in patients who transitioned from placebo to efgartigimod. Low disease activity is indicated by a ClinESSDAI score of <5. Efgartigimod was well tolerated, with no new safety signals identified following long-term use in participants with Sjogren’s disease. The Phase 3 UNITY trial is currently ongoing to assess efficacy and safety of efgartigimod in patients with moderate to severe Sjogren’s disease. Topline results are expected in the second half of 2027. Efgartigimod safety pro across autoantibody-driven autoimmune diseases A cross-indication safety analysis of efgartigimod spanning multiple global clinical studies, including autoimmune rheumatic diseases, indicated that efgartigimod is consistently well-tolerated across diseases and administration methods. Data showed a consistent safety pro 834 treated patients and more than 1,300 patient-years of follow-up. Efgartigimod was well tolerated in participants with autoimmune rheumatic diseases (myositis, Sjogren's disease, and lupus nephritis), consistent with findings from prior studies in other IgG-mediated autoimmune diseases and also consistent with what has been observed in approved indications globally. Adverse events were predominantly mild-to-moderate, and no increased event rates were seen in studies with a longer treatment duration. Deepening understanding of the underlying biology Additional argenx activities include: the presentation of the Phase 2 eSScape study design, evaluating the potential of efgartigimod in Systemic Sclerosis (SSc); an FcRn symposium exploring the role of autoantibodies in autoimmune rheumatic diseases and highlighting the potential of targeting FcRn; and the launch of a new myositis disease education campaign. argenx additional information on the data at EULAR 2026 can be found here . Details for argenx presentations are as follows: Title Lead Author Presentation Myositis The Long-Term Safety and Efficacy of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy: Results From the Phase 2 Randomized ALKIVIA and Open-Label Extension ALKIVIA+ Trials Rohit Aggarwal Poster #POS0261 Friday, June 5 13:36 BST Sjogren’s Disease Long-Term Efficacy and Safety of Efgartigimod in Sjogren’s Disease: Findings from the RHO+ Open-Label Extension Study Isabelle Peene Oral Presentation #130 Wednesday, June 3 17:30-17:40 BST Systemic Sclerosis Efgartigimod PH20 Subcutaneous in Adults With Systemic Sclerosis: Design of a Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study (eSScape) Dinesh Khanna Poster #POS0326 Friday, June 5 16:30 BST Multiple Disease Areas Safety Pro Efgartigimod Across Multiple Global Clinical Trials in Immunoglobulin G-Mediated Autoimmune Diseases With Emerging Data in Idiopathic Inflammatory Myopathy, Sjogren’s Disease, and Lupus Nephritis Hector Chinoy Poster #POS1200 Saturday, June 6 10:15 BST About Efgartigimod and Efgartigimod SC Efgartigimod (efgartigimod alfa fcab) is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. It is the first approved FcRn blocker for the treatment of generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and for primary immune thrombocytopenia (ITP) in Japan. Efgartigimod SC is a subcutaneous combination of efgartigimod alfa and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. About Myositis Myositis is an autoimmune rheumatic disease that can be progressive and may lead to significant muscle and organ involvement, resulting in functional impairment and substantial burden for patients. It is characterized by skeletal muscle weakness with possible extramuscular manifestations involving the skin, joints, lungs, gastrointestinal tract, and heart. Major subtypes include immune-mediated necrotizing myopathy (IMNM), dermatomyositis (DM), polymyositis (PM), antisynthetase (ASyS), and inclusion body myositis, with muscle involvement being a common manifestation across most subtypes. About ALKIVIA and ALKIVIA+ Study Design The ALKIVIA study is a randomized, double-blind, placebo-controlled, multicenter, operationally seamless Phase 2/3 study of efgartigimod SC for the treatment of autoimmune myositis across IMNM, DM and PM. The ALKIVIA study enrolled 240 patients in total and is being conducted in two phases, with an analysis of the Phase 2 portion of the clinical trial after the first 90 patients completed the study, followed by a Phase 3 portion if a signal is observed in the Phase 2 portion. The primary endpoint is the mean total improvement score (TIS) at the end of the treatment period (24 weeks in Phase 2 and 52 weeks in Phase 3) of all treated patients (IMNM, DM and PM) compared to placebo. Key secondary endpoints include response rates at the end of treatment, time to response, and duration of response in TIS, as well as change from baseline in individual TIS components. Other secondary endpoints include quality of life and other functional scores. ALKIVIA+ is a 28-week open-label extension study that evaluated myositis patients who received continuous efgartigimod treatment and those who transitioned from placebo to efgartigimod after completing the 24-week double-blind, placebo-controlled Phase 2 ALKIVIA study. The primary endpoint of ALKIVIA+ is long-term safety and tolerability. About Sjogren’s Disease Sjogren’s disease is a chronic and progressive, systemic, autoimmune rheumatic disease associated with elevated autoantibodies and characterized by immune-mediated dysfunction of exocrine glands and extraglandular organ manifestations. Sjogren's disease can be severely debilitating and have a negative impact on patient quality of life, with common symptoms reported as dry eyes and mouth, fatigue, and joint pain. Sjogren's disease predominantly impacts women with a 9:1 female:male incidence ratio. Given the heterogeneous nature of the disease, the treatment journey can be challenging with long delays and high rates of misdiagnosis. There are no FDA-approved treatments targeting the disease itself, leaving current treatments to focus primarily on individual symptom management. About RHO and RHO+ Study Design The Phase 2 RHO study was a randomized, double-blinded, placebo-controlled multicenter proof-of-concept study to evaluate the safety and efficacy of efgartigimod in adults with Sjogren’s disease. In order to enter the study, patients needed to test positive for anti-Ro autoantibodies and maintain residual salivary flow. Thirty-four patients were randomized 2:1 to receive either efgartigimod or placebo for up to 24 weeks. Multiple endpoints and biomarkers were evaluated in the signal-finding study, including the primary endpoint of CRESS (Composite of Relevant Endpoints for Sjogren’s Syndrome). Within CRESS there are five components, spanning: systemic disease activity as measured by the ESSDAI (EULAR Sjogren’s Syndrome Activity Index), patient reported outcomes as measured by the ESSPRI (EULAR Sjogren’s Syndrome Patient Reported Index), tear and salivary gland function, and serology. To be a CRESS responder, patients needed to demonstrate a clinically meaningful benefit in at least 3 of the 5 composite items. Additional datapoints were gathered including the ClinESSDAI, STAR (Sjogren’s Tool for Assessing Response), biomarker data, and the change in lymphocytic infiltrate levels through parotid biopsies. RHO+ was a 48-week open-label extension study that evaluated the safety of efgartigimod in adult patients with Sjogren's disease who continued to receive efgartigimod IV, and those who transitioned from placebo to efgartigimod IV after completing the 24-week double-blind treatment period of the Phase 2 RHO study. The primary endpoint of RHO+ was incidence and severity of AEs and AESIs, incidence of SAEs, changes in laboratory test results, vital signs, and ECG results. About UNITY Study Design UNITY is an ongoing Phase 3 randomized, double-blinded, placebo-controlled multicenter study with open-label extension to evaluate the efficacy, safety, and tolerability of subcutaneously administered efgartigimod PH20, in adult participants with moderate-to-severe primary Sjogren’s disease. About argenx argenx 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 and follow us on LinkedIn , Instagram , Facebook , and YouTube . For further information, please contact: Media: Kate Dion kdion@argenx.com Colin McBean cmcbean@argenx.com Investors: Alexandra Roy aroy@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 generally can be identified by the use of forward-looking words, such as “aim”, “anticipate”, “aspire”, “believe”, “can”, “continue”, “could”, “estimate”, “expect”, “entail”, “forecast”, “future”, “goals”, “hope”, “intend”, “is designed to”, “likely”, “may”, “might”, “objective”, “plan”, “possible”, “potential”, “pursue”, “project”, “predict”, “seek”, “should”, “strategy”, “target”, “will” and other words and terms of similar meaning and expression, including in connection with any discussion of future operating or financial performance. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx’s clinical trials; uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development risks and setbacks; interpretation of argenx’s clinical trial data by regulatory authorities and argenx’s ability to obtain regulatory approval; the risk that early stage clinical trials may not be predictive of results in later stage or large scale clinical trials; the occurrence of adverse safety events or participant dropouts; the acceptance of its products and product candidates by its patients as safe, effective, and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; the impact of healthcare regulations, including rules on reimbursement for argenx’s products; competition in drug discovery, development and commercialization efforts; its reliance on third-party suppliers, service providers and manufacturers; and instability and conflicts in the regions in which the company has suppliers or markets for its products. A further list and description of these and other risks, uncertainties, and factors that could cause actual results to differ materially from those referred to in the forward-looking statements can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these risks and uncertainties, the reader is advised not to place undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this press release. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

11 May 2026

·www.prnewswire.com

HALOZYME REPORTS FIRST QUARTER 2026 RESULTS AND REITERATES 2026 FINANCIAL GUIDANCE

Announcing New $1 billion Share Repurchase Program Projecting to Buy Back at Least $400 million in 2026 Total Revenue Increased 42% YOY to $377 million Royalty Revenue Increased 43% YOY to $241 million Reiterating 2026 Financial Guidance Ranges: Total Revenue of $1.710 - $1.810 billion, YOY Growth of 22% - 30% Royalty Revenue of $1.130 - $1.170 billion, YOY Growth of 30% - 35% Adjusted EBITDA of $1.125 - $1.205 billion, YOY Growth of 71% - 83%1 Non-GAAP Diluted EPS of $7.75 - $8.25, YOY Growth of 87% - 99%1 SAN DIEGO, May 11, 2026 /PRNewswire/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the first quarter ended March 31, 2026, and provided an update on its recent corporate activities. "I am pleased to announce our new $1 billion share repurchase program and that we project to repurchase at least $400 million in 2026, which is a reflection of our strong cash generation and confidence in the long-term value and durability of our business. We started 2026 with exceptional momentum, highlighted by three new recent collaboration and licensing agreements with Vertex, Oruka and GSK, demonstrating the strong interest in Hypercon and ENHANZE and showcasing the real potential to exceed our goal of three new SC delivery platform deals this year. The two Hypercon multi-target agreements confirm the strong interest of biopharma companies to reduce injection volume through hyperconcentration and allow more flexible administration in the home. Our new multi-target agreement with GSK represents a significant opportunity for ENHANZE with multiple promising oncology targets, including its first potential application with antibody drug conjugates. This momentum creates durable new royalty opportunity beginning in the 2030s and extending to at least the mid-2040s," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme. "The growing number of indications for our approved products and new Phase 3 data milestones represent increased opportunity for ENHANZE. Most recently, VYVGART Hytrulo was FDA-approved for all serotypes of generalized myasthenia gravis (gMG), representing a significant expansion of addressable patients. The VYVGART Hytrulo opportunity is further extended with positive Phase 3 data in ocular myasthenia gravis, increasing the MG addressable market by an additional 7,000 patients in the U.S. alone. Additionally, DARZALEX Faspro gained its 12th and 13th approved indications and expanded further in newly diagnosed and early second line multiple myeloma patients, the two largest, longer-duration of treatment patient populations. Takeda also announced positive Phase 2/3 data for its 20% immunoglobulin TAK-881 in patients with primary immune deficiency, creating the potential for the 11th ENHANZE product launch." "Our opportunity with ENHANZE was further enhanced in the quarter by two new Phase 1 study starts, increasing the number of ENHANZE products in development to nine, well on our way to the expected 13 ENHANZE products in development by year-end 2026. We project these ENHANZE products have the potential for approvals beginning in 2029+, creating a new wave of royalty revenue. The five signed Hypercon agreements, which include the opportunity for 17 targets to be developed, with first approvals projected in the 2030/2031 time period represents a third exciting wave of new royalty revenue opportunity. This continued performance and progress resulted in strong first quarter financial results and we are pleased to reaffirm our 2026 outlook, including expectations for ENHANZE royalty revenue to exceed $1 billion for the full year," Dr. Torley concluded. Recent Corporate Highlights: In May 2026, the Company announced a new share repurchase program to repurchase up to $1 billion of its outstanding common stock by December 31, 2028, with an expectation of buying back at least $400 million of shares in 2026. Recent Partner Highlights: In May 2026, argenx announced U.S. Food and Drug Administration ("FDA") approval of a supplemental Biologics License Application ("sBLA") for VYVGART® Hytrulo with ENHANZE® for the treatment of adult patients with generalized myasthenia gravis ("gMG") including all serotypes – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative. In May 2026, Halozyme and GSK plc ("GSK") entered into a global collaboration and license agreement for ENHANZE® with multiple oncology targets, including the first potential application in antibody-drug conjugates ("ADCs"). Under the terms of the agreement, GSK will make an upfront payment and potential future milestone payments and royalties on net sales of products developed with ENHANZE®. In May 2026, Halozyme and Oruka Therapeutics, Inc. ("Oruka") entered into a global exclusive collaboration and license agreement for Halozyme's Hypercon™ technology for use with ORKA-001, in development for psoriasis and related inflammatory diseases and one additional target. Under the terms of the agreement, Oruka will make an upfront payment and potential future milestone payments and mid-single digit royalties on net sales of products developed using the Hypercon™ technology. In May 2026, Takeda announced positive topline results from its pivotal Phase 2/3 trial of TAK-881 with ENHANZE® in Primary Immunodeficiency Disease. In April 2026, Halozyme and Vertex Pharmaceuticals Incorporated ("Vertex") entered into a global exclusive collaboration and license agreement that provides Vertex access to Hypercon™ technology for use in up to three targets. Under the terms of the agreement, Vertex will make a $15 million upfront payment and potential future milestone payments and royalties on net sales of products developed using the Hypercon™ technology. First Quarter Partner Highlights: In March 2026, Pfizer nominated a new undisclosed non-exclusive target to be studied with ENHANZE®. In March 2026, Janssen announced the Committee for Medicinal Products for Human Use of the European Medicines Agency granted approval for self or caregiver administration of DARZALEX (daratumumab) SC formulation for patients living with multiple myeloma from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training, making it the first oncology injectable approved for self-administration in Europe. In March 2026, Janssen announced the FDA approved TECVAYLI® (teclistamab-cqyv) in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. In February 2026, argenx announced positive topline results from the Phase 3 ADAPT oculus trial of VYVGART® with ENHANZE® in ocular myasthenia gravis. In January 2026, argenx initiated a Phase 1 study to evaluate ARGX-124 with ENHANZE®. In January 2026, Janssen announced the FDA approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. First Quarter 2026 Financial Highlights: Total revenue was $376.7 million, compared to $264.9 million in the first quarter of 2025. The 42% year-over-year increase was primarily driven by royalty revenue growth and an increase in product sales. Revenue included $240.7 million in royalties, an increase of 43% compared to $168.2 million in the first quarter of 2025, primarily driven by continued sales uptake of ENHANZE® partner products that have launched since 2020, predominantly DARZALEX® SC by Janssen, VYVGART® Hytrulo by argenx and Phesgo® by Roche in all geographies and contributions from other recently launched products. Cost of sales was $79.2 million, compared to $48.4 million in the first quarter of 2025. The increase in cost of sales was primarily due to an increase in bulk rHuPH20 sales. Amortization of intangibles expense was $29.5 million, compared to $17.8 million in the first quarter of 2025. The increase in amortization of intangibles expense was due to the acquisition of Elektrofi, Inc. ("Elektrofi") in November 2025. Research and development expense was $25.6 million, compared to $14.8 million in the first quarter of 2025. The increase was primarily due to the acquisition of Elektrofi and Surf Bio, Inc. ("Surf Bio") in the fourth quarter of 2025. Selling, general and administrative expense was $57.9 million, compared to $42.4 million in the first quarter of 2025. The increase was primarily due to an increase in consulting and professional service fees, including litigation costs incurred in connection with patent infringement litigation, the acquisition of Elektrofi and Surf Bio, and an increase in compensation expense. Operating income was $184.5 million, compared to $141.5 million in the first quarter of 2025. Net income was $150.0 million, compared to $118.1 million in the first quarter of 2025. EBITDA was $218.3 million, compared to $162.0 million in the first quarter of 2025. Adjusted EBITDA was $229.5 million, compared to $162.0 million in the first quarter of 2025.1 GAAP diluted earnings per share was $1.22, compared to $0.93 in the first quarter of 2025. Non-GAAP diluted earnings per share was $1.60, compared to $1.11 in the first quarter of 2025.1 Cash, cash equivalents, restricted cash and marketable securities were $320.9 million on March 31, 2026, compared to $145.4 million on December 31, 2025. The increase was primarily driven by cash generated from operations. Financial Outlook for 2026 The Company is reiterating its 2026 financial guidance ranges, which were last provided on February 17, 2026. For the full year 2026, the Company expects: Total revenue of $1.710 billion to $1.810 billion, representing growth of 22% to 30% over 2025 total revenue, primarily driven by increases in royalty revenue and product sales from API. Revenue from royalties of $1.130 billion to $1.170 billion, representing growth of 30% to 35% over 2025. Adjusted EBITDA of $1.125 billion to $1.205 billion, representing growth of 71% to 83% over 2025, including new Hypercon™ and Surf Bio investment of approximately $60 million. Non-GAAP diluted earnings per share of $7.75 to $8.25, representing growth of 87% to 99% over 2025. The Company's earnings per share guidance includes new Hypercon™ and Surf Bio investment of approximately $60 million and does not consider the impact of potential future share repurchases. Table 1. 2026 Financial Guidance Webcast and Conference Call Halozyme will host its Quarterly Update Conference Call for the first quarter ended March 31, 2026 today, Monday, May 11, 2026, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: . The call will also be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution facilitates the subcutaneous delivery of injected drugs and fluids, reducing treatment burden and improving convenience. ENHANZE® has touched more than one million patient lives through ten commercialized products across over 100 global markets and is licensed to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, Acumen Pharmaceuticals, Merus N.V., Skye Bioscience and GSK. Halozyme expanded its drug delivery technology portfolio to develop partner products using Hypercon™ and Surf Bio's hyperconcentration technology. Hypercon™ is an innovative microparticle technology expected to set a new standard in hyperconcentration of drugs and biologics by reducing injection volume for the same dosage and enabling administration in at-home and healthcare-provider settings. The addition of Surf Bio's polymer-based hyperconcentration technology further broadens the range of biologics that can be delivered subcutaneously, meaningfully expanding the scope of opportunities across therapeutic modalities. Together, HyperconTM and Surf Bio's technology complement ENHANZE® by enabling creation and delivery of highly concentrated biologics. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Janssen, Eli Lilly, argenx, Vertex Pharmaceuticals, and Oruka Therapeutics. Halozyme also develops, manufactures and commercializes drug-device combination products using advanced auto-injector technologies designed to improve convenience, reliability and tolerability, enhancing patient comfort and adherence. The Company has two proprietary commercial products, Hylenex® and XYOSTED®, partnered commercial products and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA, with offices in Ewing, NJ; Minnetonka, MN; and Boston, MA. Minnetonka is also the site of its operations facility. For more information, visit and connect with us on LinkedIn. Note Regarding Use of Non-GAAP Financial Measures In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), this press release and the accompanying tables contain certain Non-GAAP financial measures. The Company reports earnings before interest, taxes, depreciation, and amortization ("EBITDA"), adjusted EBITDA, Non-GAAP diluted earnings per share, Non-GAAP diluted shares, and guidance with respect to those measures, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company calculates Non-GAAP diluted earnings per share excluding share-based compensation expense, amortization of debt discounts, intangible asset amortization, one-time items, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges, transaction costs for business combinations, severance and share-based compensation acceleration expenses, intellectual property litigation costs, inducement expenses related to convertible notes, and certain adjustments to income tax expense. The Company calculates Non-GAAP diluted shares excluding the dilutive impact of convertible notes which is used in calculating Non-GAAP diluted earnings. The Company calculates EBITDA excluding interest, taxes, depreciation and amortization. The Company calculates adjusted EBITDA excluding one-time items, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges, transaction costs for business combinations, severance and share-based compensation acceleration expenses and intellectual property litigation costs. Reconciliations between GAAP and Non-GAAP financial measures are included at the end of this press release. The Company does not provide reconciliations of forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in share-based compensation expense and the effects of any discrete income tax items. For the same reasons, the Company is unable to address the probable significance of the unavailable information. The Company provides Non-GAAP financial measures that it believes will be achieved; however, it cannot accurately predict all of the components of the adjusted calculations and the GAAP measures may be materially different than the Non-GAAP measures. The Company evaluates other items of income and expense on an individual basis for potential inclusion in the calculation of Non-GAAP financial measures and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company's ongoing business operations and (iii) whether or not the Company expects it to occur as part of the Company's normal business on a regular basis. Non-GAAP financial measures do not have any standardized meaning and are therefore unlikely to be comparable to similarly titled measures presented by other companies. These Non-GAAP financial measures are not meant to be considered in isolation and should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP, and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its Non-GAAP financial measures, and the Company may in the future cease to exclude items that it has historically excluded for purposes of its Non-GAAP financial measures. The Company considers these Non-GAAP financial measures to be important because they provide useful measures of the operating performance of the Company, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The Non-GAAP measures also allow investors and analysts to make additional comparisons of the operating activities of the Company's core business over time and with respect to other companies, as well as assessing trends and future expectations. The Company uses Non-GAAP financial information in assessing what it believes is a meaningful and comparable set of financial performance measures to evaluate operating trends, as well as in establishing portions of our performance-based incentive compensation programs. Safe Harbor Statement In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's financial performance (including the Company's expected financial outlook for 2026) and expectations for future growth, profitability, revenue durability, total revenue, royalty revenue, royalty revenue duration, EBITDA, Adjusted EBITDA, and non-GAAP diluted earnings-per-share, and shareholder value and potential future share repurchases. These forward-looking statements also include statements regarding the Company's potential receipt of upfront payments and payments associated with achievement of certain development, regulatory and sales-based milestones, and royalties on sales of commercialized products from recent collaboration agreements. Forward-looking statements also include future plans, objectives, expectations and intentions related to the acquisitions of Elektrofi and Surf Bio, such acquisitions' expected impact and contributions to the Company's and combined group's operations and financial results (including potential development and commercialization of partnered products and timing related to these events), as well as the expected benefits of the acquisitions. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible benefits and attributes of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery including its potential application with antibody drug conjugates. Forward-looking statements regarding the Company's Hypercon™ technology include the possible benefits and attributes of the Hypercon™ technology, including the potential to reduce injection volume for the same dosage of drugs and biologics and possibly enabling administration in at–home and healthcare–provider settings and statements concerning certain other potential benefits of the Hypercon™ technology including facilitating administration of injectable medications through subcutaneous delivery by enabling creation and delivery of highly concentrated biologics and potentially lowering the treatment burden, easing treatment access and improving the treatment experience for patients. Forward-looking statements regarding the Company's business may include potential growth and receipt of royalty and milestone payments driven by our partners' development and commercialization efforts, potential new clinical trial study starts and advancement of partnered development programs, regulatory submissions and product launches, the size and growth prospects of our partners' drug franchises, potential new or expanded collaborations and collaborative targets, and potential approvals of new partnered or proprietary products, and the potential timing of these events. These forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "preliminary," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including uncertainties concerning future matters such as unexpected results or delays in the Company's repurchases of the Company's shares under the recently approved share repurchase program, market conditions, changes in domestic and foreign business, changes in the competitive environment in which the Company operates, the expected benefits of its acquisitions of Elektrofi and Surf Bio, unexpected early expiration or termination of the patent terms for the Company's drug delivery technologies, unexpected levels of revenues, expenditures and costs, unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered or proprietary products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, including under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". Except as required by law, the Company undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-333-7668 [email protected] Sydney Charlton Teneo 917-972-8407 [email protected] SOURCE Halozyme Therapeutics, Inc. 21% more press release views with Request a Demo

Clinical ResultPhase 1Drug ApprovalLicense out/inPhase 3

11 May 2026

·firstwordpharma.com

Biopharma bites: CSL pummeled by $5B in charges, plus a label expansion for argenx's Vyvgart

CSL hit by lowered outlook, $5B in new chargesargenx's Vyvgart bags broader FDA labelCSL hit by lowered outlook, $5B in new chargesShares in CSL plunged 16% on Monday after the company cut its revenue forecast for the current financial year and disclosed additional impairment charges of $5 billion. Interim CEO Gordon Naylor, who has completed a strategic review of the firm, said that while "growth initiatives are working…the financial benefits will take longer than previously anticipated to materialise."CSL expects sales this year of $15.2 billion, having previously guided for 2% to 3% growth over the prior 12 months. The company's fiscal year ends June 30; last year, it recorded $15.6 billion in revenue. CSL explained that the downgrade reflects $300 million less revenue from immunoglobulin products in the US due to "normalisation of channel inventory," as well as a $200-million hit from albumin sales in China as the "market value has declined."Having previously indicated that it would record $1.1 billion in impairment charges, CSL said Monday that it faces a further $5-billion hit across this year and next. The new charges relate to CSL Vifor's intangible assets, including the product portfolio, as well as underutilised property, plant and equipment. -Matt Dennisargenx's Vyvgart bags broader FDA labelThe FDA broadened approval of argenx's Vyvgart (efgartigimod alfa) and its subcutaneous variant Vyvgart Hytrulo to include all disease serotypes in adults with generalised myasthenia gravis (gMG). These include anti-MuSK-Ab positive, anti-LRP4-Ab positive and triple seronegative populations, in addition to the previously approved anti-acetylcholine receptor antibody (AChR-Ab)-positive subgroup.The latest label expansion was backed by data from the Phase III ADAPT SERON study of AChR-Ab seronegative patients with gMG, wherein the Vyvgart arm showed a significant 3.35-point improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) total score over placebo at week four, with sustained gains noted across subsequent treatment cycles."For clinicians, this simplifies treatment decisions, representing a major advancement in reaching as many patients living with gMG as possible,” said Luc Truyen, chief medical officer at argenx. Meanwhile, the company continues to pursue development of the neonatal Fc receptor blocker in ocular MG and paediatric gMG through the ADAPT OCULUS and ADAPT Jr trials, respectively.-Pavan Kamat

Phase 3Financial StatementClinical ResultDrug Approval

100 Deals associated with Efgartigimod/Hyaluronidase

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Approved

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Indication	Country/Location	Organization	Date
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	United States	argenx SE	21 Jun 2024
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	United States	argenx BV	21 Jun 2024
Myasthenia Gravis	United States	argenx BV	20 Jun 2023

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Graves Disease	Phase 3	-	argenx SE	01 Jun 2026
Primary Sjögren's syndrome	Phase 3	United States	argenx BV	17 Dec 2024
Primary Sjögren's syndrome	Phase 3	United States	Zai Lab (Shanghai) Co., Ltd.	17 Dec 2024
Primary Sjögren's syndrome	Phase 3	Japan	argenx BV	17 Dec 2024
Primary Sjögren's syndrome	Phase 3	Japan	Zai Lab (Shanghai) Co., Ltd.	17 Dec 2024
Primary Sjögren's syndrome	Phase 3	Argentina	argenx BV	17 Dec 2024
Primary Sjögren's syndrome	Phase 3	Argentina	Zai Lab (Shanghai) Co., Ltd.	17 Dec 2024
Primary Sjögren's syndrome	Phase 3	Austria	Zai Lab (Shanghai) Co., Ltd.	17 Dec 2024
Primary Sjögren's syndrome	Phase 3	Austria	argenx BV	17 Dec 2024
Primary Sjögren's syndrome	Phase 3	Belgium	Zai Lab (Shanghai) Co., Ltd.	17 Dec 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04280718 (ADHERE+, MDA2026)	Phase 2	Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	229	Efgartigimod PH20 SC 1000 mg	kxrsagfrnd(dfgmtutchj) = pjbmcqrfgo rdtreafnuu (rlwzdyarmk ) View more	Positive	08 Mar 2026
NCT04281472 (ADHERE, MDA2026)	Phase 2	Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	221	Efgartigimod PH20 SC 1000 mg	dnaomdxahj(azasqlsdsr) = ktbqegofcs qchvgbqfjy (lrtkevlwfz ) View more	Positive	08 Mar 2026
				Placebo	dnaomdxahj(azasqlsdsr) = vfkjbnjnmi qchvgbqfjy (lrtkevlwfz ) View more
NCT05523167 (ALKIVIA, MDA2026)	Phase 2/3	Idiopathic Inflammatory Myopathies	89	Efgartigimod PH20 SC	xeafyrqkgz(skmcjqjmlk) = eykzlegbwl geymjusjpu (ddymlfusml )	Positive	08 Mar 2026
				Placebo	xeafyrqkgz(skmcjqjmlk) = gcmxfombto geymjusjpu (ddymlfusml )
NCT04818671 (ADAPTSC+ \| ADAPT-SC+, CTgov)	Phase 3	Myasthenia Gravis	184	efgartigimod PH20 SC	hewfigbcdl = cgbkghisiv dsstvyidef (qbyhxtlisy, iccmyqswaz - ujmbczmwdd) View more	-	22 Jan 2026
NCT05523167 (ALKIVIA, ACR2025)	Phase 2/3	Idiopathic Inflammatory Myopathies	89	Efgartigimod PH20 SC plus standard of care (SOC)	baamefexfn(kkgxveetrz) = qhkhjyyqxy maxeelwghq (qrsimkjyth ) View more	Positive	24 Oct 2025
				Placebo PH20 (PBO) plus SOC	baamefexfn(kkgxveetrz) = mvlxpbkwau maxeelwghq (qrsimkjyth ) View more
NCT05267600 (BALLAD, CTgov)	Phase 2/3	Pemphigoid, Bullous	98	Prednisone+efgartigimod PH20 SC (Efgartigimod PH20 SC)	iasdosodcs = fgbjfslfbe cqmwlwfwlb (srglpcqdfx, ovcmhcjpwm - frkuexrfda) View more	-	23 Oct 2025
				placebo+Prednisone (Placebo PH20 SC)	iasdosodcs = hylcgpnzrt cqmwlwfwlb (srglpcqdfx, wvruidgguz - gipxiobkay) View more
NCT04818671 (ADAPT-SC+, Neurology \| AAN2025) Manual	Not Applicable	Myasthenia Gravis	179	Efgartigimod PH20 SC 1000 mg	jblelpnvcp(vweuyteltu) = xbpkrkhehp zjyivgitwi (dftsohpful, 0.27) View more	Positive	07 Apr 2025
NCT04280718 \| NCT04281472 (ADHERE+, Neurology \| AAN2025) Manual	Phase 2	Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	322	Efgartigimod PH20 SC 1000 mg (ADHERE)	hbtjlqwvwa(jufjvtitts) = knlandbgdm jvgjdqpviw (ciymjeyeih, 0.10) View more	Positive	07 Apr 2025
				Efgartigimod PH20 SC 1000 mg (ADHERE+)	hbtjlqwvwa(jufjvtitts) = jsgexpixsp jvgjdqpviw (ciymjeyeih, 0.15) View more
NCT04281472 (ADHERE, AAN2025)	Phase 2	Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	-	Efgartigimod PH20 SC 1000 mg	iijuiwbmvo(vybfzkwzri) = gfgjiqneun amqnhozxkg (bjhlfmfnkv ) View more	Positive	07 Apr 2025
				Placebo	iijuiwbmvo(vybfzkwzri) = mwwzvwqgcf amqnhozxkg (bjhlfmfnkv ) View more
NCT04598477 (ADDRESS+, CTgov)	Phase 3	Pemphigus \| Acne Vulgaris	183	efgartigimod PH20+Efgartigimod (Efgartigimod-efgartigimod PH20 SC)	yvdihzwfgv = wjtiaozloi xnmufqozly (cbrlxxsout, jacrgbhpoy - ylfgxhicfh) View more	-	30 Mar 2025
				Placebo+efgartigimod PH20 (Placebo-efgartigimod PH20 SC)	yvdihzwfgv = cspgvtgpgr xnmufqozly (cbrlxxsout, irwthfksbp - ejghkhneoc) View more

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