This section highlights FDA-related milestones and regulatory updates for drugs developed by argenex (ARGX).
Over the past two years, argenex has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ALKIVIA, ARGX-119, efgartigimod, VYVGART, and VYVGART. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ALKIVIA - FDA Regulatory Timeline and Events
ALKIVIA is a drug developed by argenex for the following indication: In Idiopathic Inflammatory Myopathies.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ALKIVIA
- Announced Date:
- November 20, 2024
- Indication:
- In Idiopathic Inflammatory Myopathies
Announcement
argenx SE announced the decision to continue development of efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in the ongoing Phase 2/3 ALKIVIA study in adults with idiopathic inflammatory myopathies (IIM or myositis),
AI Summary
argenx SE announced that it will continue the development of efgartigimod subcutaneous (SC) in its ongoing Phase 2/3 ALKIVIA study, focusing on adults with idiopathic inflammatory myopathies (IIM), also known as myositis. The study will keep enrolling patients from all three subtypes—immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and dermatomyositis (DM). Phase 2 data showed promising efficacy and safety results, which supports the decision to move forward with Phase 3.
This move reflects the potential of efgartigimod SC to become the first targeted treatment for myositis patients who have limited treatment options. argenx is excited to explore this precision therapy further, aiming to address significant unmet needs in patients suffering from these debilitating autoimmune conditions.
Read Announcement
ARGX-119 - FDA Regulatory Timeline and Events
ARGX-119 is a drug developed by argenex for the following indication: In Congenital Myasthenic Syndromes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ARGX-119
- Announced Date:
- June 30, 2025
- Indication:
- In Congenital Myasthenic Syndromes
Announcement
argenx SE announced its plan to advance the clinical development of ARGX-119, a first-in-class agonist antibody to muscle-specific kinase (MuSK), to a registrational study in patients with congenital myasthenic syndromes (CMS) following the analysis of topline data from the Phase 1b study.
AI Summary
argenx SE announced that it will advance ARGX-119—a first-in-class agonist antibody targeting muscle-specific kinase (MuSK)—to a registrational study in patients with congenital myasthenic syndromes (CMS). This decision follows the favorable topline data from the Phase 1b study, which demonstrated a strong safety profile and consistent functional improvements in multiple efficacy measures among CMS patients. The study provided proof of concept, showing that ARGX-119 could improve muscle strength and daily functioning in a patient population affected by this ultra-rare disorder. The positive results underline the potential of ARGX-119 to address unmet needs in CMS, a condition that causes debilitating muscle weakness from birth. This registrational study marks an important next step in argenx’s goal to develop innovative therapies by building on its deep biological insights and expertise in antibody engineering.
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efgartigimod - FDA Regulatory Timeline and Events
efgartigimod is a drug developed by argenex for the following indication: To reduce pathogenic immunoglobulin G (IgG).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- efgartigimod
- Announced Date:
- December 27, 2024
- Indication:
- To reduce pathogenic immunoglobulin G (IgG)
Announcement
argenx SE announced that Japan's Ministry of Health, Labour and Welfare (MHLW) approved VYVDURA for adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
AI Summary
argenx SE announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved VYVDURA for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). This approval marks a significant milestone for CIDP patients in Japan, offering them a new treatment option that can be self-administered at home. VYVDURA is delivered as a once-weekly subcutaneous injection, which only takes 30 to 90 seconds to complete. The therapy is the first and only neonatal Fc receptor (FcRn) blocker for CIDP, a rare autoimmune disease that causes muscle weakness, mobility issues, and sensory problems. The MHLW decision was based on robust findings from the ADHERE clinical trial, where a majority of patients showed improvement in mobility and strength, and a notable reduction in relapse risk. This approval highlights argenx’s commitment to introducing innovative treatments for severe autoimmune conditions.
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VYVGART (efgartigimod alfa) - FDA Regulatory Timeline and Events
VYVGART (efgartigimod alfa) is a drug developed by argenex for the following indication: For Adults with Primary Immune Thrombocytopenia.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VYVGART (efgartigimod alfa)
- Announced Date:
- June 10, 2025
- Indication:
- For Adults with Primary Immune Thrombocytopenia
Announcement
argenx SE announced the presentation of positive results from Phase 2 studies evaluating VYVGART® (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) in Sjogren's disease (SjD) and idiopathic inflammatory myopathies (IIM or myositis) at the European Congress of Rheumatology, EULAR 2025, from June 11 – 14 in Barcelona, Spain.
AI Summary
argenx SE recently announced positive Phase 2 study results for VYVGART®, its investigational treatment for both Sjogren’s disease and idiopathic inflammatory myopathies (myositis). The data, presented at the European Congress of Rheumatology (EULAR) 2025 in Barcelona from June 11 to 14, showed that the drug could reduce disease activity by targeting IgG autoantibodies. VYVGART is available in two forms: an intravenous formulation (efgartigimod alfa-fcab) and a subcutaneous formulation with hyaluronidase-qvfc (Hytrulo). The studies demonstrated promising improvements in functional outcomes and disease scores, suggesting that efgartigimod may offer a new precision therapy option for patients with these challenging autoimmune conditions. argenx’s innovative approach, which focuses on the underlying mechanisms of autoimmune diseases, is aimed at moving beyond symptom management by addressing the root cause of inflammation in these patient populations.
Read Announcement- Drug:
- VYVGART (efgartigimod alfa)
- Announced Date:
- April 28, 2025
- Indication:
- For Adults with Primary Immune Thrombocytopenia
Announcement
argenx SE announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended European Commission (EC) approval of VYVGART® 1000mg (efgartigimod alfa) for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins.
AI Summary
argenx SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of VYVGART® 1000mg (efgartigimod alfa) by the European Commission. This drug, designed as a subcutaneous (SC) injection, is proposed as a monotherapy for adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) who have already been treated with corticosteroids or immunoglobulins. VYVGART is notable for being the first and only targeted IgG Fc-antibody fragment available for CIDP, introducing a new mechanism of action for the condition after more than 30 years. The CHMP recommendation is based on the positive results of the ADHERE clinical trial—CIDP’s largest study to date—which demonstrated significant clinical improvements. The European Commission is expected to issue a final decision on the marketing authorization within about two months.
Read Announcement- Drug:
- VYVGART (efgartigimod alfa)
- Announced Date:
- March 7, 2025
- Indication:
- For Adults with Primary Immune Thrombocytopenia
Announcement
argenx SE announced clinical trial and real-world data for VYVGART® (efgartigimod alfa-fcab) and VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) will be presented at the American Academy of Neurology (AAN) Annual Meeting, taking place in San Diego, CA from April 5-9, 2025.
AI Summary
argenx SE announced that it will present new clinical trial and real-world data for its treatments VYVGART® (efgartigimod alfa-fcab) and VYVGART® Hytrulo (efgartigimod alfa with hyaluronidase-qvfc) at the American Academy of Neurology Annual Meeting in San Diego, CA, from April 5-9, 2025. The upcoming presentations will highlight the largest safety data set for an FcRn blocker, demonstrating a consistent and favorable safety profile along with rapid, substantial, and sustained efficacy in patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). The data supports a personalized treatment approach and showcases improvements in functional ability across multiple dosing regimens. These findings reinforce VYVGART and VYVGART Hytrulo’s potential as leading biologic therapies in the management of autoimmune diseases.
Read Announcement- Drug:
- VYVGART (efgartigimod alfa)
- Announced Date:
- June 21, 2024
- Indication:
- For Adults with Primary Immune Thrombocytopenia
Announcement
argenx SE announced that the U.S. Food and Drug Administration (FDA) has approved VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
AI Summary
argenx SE recently announced that the U.S. Food and Drug Administration (FDA) has approved VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for treating adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). This once weekly subcutaneous injection is the first and only neonatal Fc receptor blocker approved for CIDP, marking a major breakthrough in more than 30 years of CIDP treatment options.
The approval is based on data from the ADHERE study, where a significant number of patients showed meaningful improvements in mobility, function, and strength. VYVGART Hytrulo offers a precision treatment tool by reducing pathogenic IgG levels, paving the way for fewer burdensome treatment procedures compared to current therapies. This new option provides hope for enhanced quality of life for those affected by this rare and often debilitating autoimmune disorder.
Read Announcement
VYVGART Hytrulo - FDA Regulatory Timeline and Events
VYVGART Hytrulo is a drug developed by argenex for the following indication: Injection for Subcutaneous Use in Generalized Myasthenia Gravis.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VYVGART Hytrulo
- Announced Date:
- April 10, 2025
- Indication:
- Injection for Subcutaneous Use in Generalized Myasthenia Gravis
Announcement
argenx SE announced that the U.S. Food and Drug Administration (FDA) approved a new option for patients to self-inject VYVGART® Hytrulo with a prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
AI Summary
argenx SE recently received FDA approval for a new self-injection option using a prefilled syringe for VYVGART® Hytrulo. This new method combines efgartigimod alfa with hyaluronidase-qvfc and is cleared for use in adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody positive, as well as for adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
The prefilled syringe allows patients to choose when and where they receive their treatment, whether at home, in a doctor’s office, or on the go. The 20-to-30-second subcutaneous injection is designed to enhance patient independence, improve convenience, and maintain the proven safety and effectiveness of VYVGART Hytrulo. This approval underscores argenx’s commitment to innovative therapies that improve the treatment experience for patients managing these autoimmune disorders.
Read Announcement- Drug:
- VYVGART Hytrulo
- Announced Date:
- September 19, 2024
- Indication:
- Injection for Subcutaneous Use in Generalized Myasthenia Gravis
Announcement
argenx SE announced publication in The Lancet Neurology of the pivotal ADHERE Study, the largest clinical trial to date in chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a rare, debilitating, often progressive, immune-mediated neuromuscular disorder of the peripheral nervous system.
AI Summary
argenx SE announced that the pivotal ADHERE Study, the largest clinical trial to date in chronic inflammatory demyelinating polyneuropathy (CIDP), has been published in The Lancet Neurology. CIDP is a rare, debilitating disorder that affects the peripheral nervous system, leading to muscle weakness, fatigue, and loss of sensation. The ADHERE Study evaluated the effectiveness of VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), an innovative treatment aimed at reducing the disease’s progression and risk of relapse. Results showed that patients using VYVGART Hytrulo had a 61% reduction in the risk of relapse compared to placebo, with rapid improvements in mobility, function, and strength. This study not only marks a key milestone in CIDP clinical research but also advances our scientific understanding of the disease, paving the way for further innovation in treating CIDP.
Read Announcement- Drug:
- VYVGART Hytrulo
- Announced Date:
- April 16, 2024
- Indication:
- Injection for Subcutaneous Use in Generalized Myasthenia Gravis
Announcement
argenx SE announced that data from its Phase 3 ADHERE trial evaluating VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) were presented for the first time to the medical community during the Clinical Trials Plenary Session at the American Academy of Neurology (AAN) Annual Meeting in Denver, CO.
AI Summary
argenx SE recently shared promising results from its Phase 3 ADHERE trial during the Clinical Trials Plenary Session at the American Academy of Neurology Annual Meeting in Denver, CO. The trial evaluated VYVGART Hytrulo—a combination of efgartigimod alfa and hyaluronidase-qvfc—in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Researchers presented data showing that a significant number of patients experienced rapid and meaningful clinical improvement. These improvements included a reduction in the risk of clinical deterioration, suggesting that the treatment may help stabilize disease symptoms while lessening side effects. The study highlighted that most participants, regardless of previous therapies, showed positive responses, paving the way for a potentially transformative therapeutic option in CIDP. This presentation marks an important milestone as it is the first time the ADHERE trial data has been shared with the medical community at a major neurology event.
Read Announcement
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