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
VYVGART, efgartigimod, efgartigimod, ARGX-119, VYVGART, and ALKIVIA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
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 under review 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:
- September 29, 2026
- Indication:
- For Adults with Primary Immune Thrombocytopenia
Announcement
argenx SE will present new data from across its portfolio and pipeline at the 2026 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and the Myasthenia Gravis Foundation of America (MGFA) Scientific Session in Orlando, Florida, from September 29 – October 2, 2026.
Read Announcement- Drug:
- VYVGART (efgartigimod alfa)
- Announced Date:
- May 8, 2026
- Indication:
- For Adults with Primary Immune Thrombocytopenia
Announcement
argenx SE announced the U.S. Food and Drug Administration (FDA) approved a label expansion for VYVGART® (efgartigimod alfa-fcab) and VYVGART Hytrulo® (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG).
AI Summary
argenx announced that the U.S. Food and Drug Administration approved a label expansion for VYVGART® (efgartigimod alfa-fcab) and VYVGART Hytrulo® (efgartigimod alfa and hyaluronidase‑qvfc) to treat adult patients with generalized myasthenia gravis (gMG). The expanded label covers all adult gMG patients regardless of serotype, and the company says this allows more patients to benefit from VYVGART’s rapid onset, sustained disease control, and favorable safety profile. The medicines are offered in three administration options, including IV infusion and VYVGART Hytrulo subcutaneous self‑injection with a prefilled syringe, which can simplify treatment choices for clinicians and patients.
argenx also offers the My VYVGART® Path support program to help with education, access, benefits verification, and financial assistance. VYVGART and VYVGART Hytrulo are prescription medicines not known to be safe or effective in children. Serious allergic reactions and low blood pressure can occur. Common side effects include respiratory tract infection, headache, urinary tract infection, and injection site reactions with Hytrulo. Patients should discuss medical history, vaccinations, pregnancy, and breastfeeding with their healthcare provider.
Read Announcement- Drug:
- VYVGART (efgartigimod alfa)
- Announced Date:
- March 6, 2026
- Indication:
- For Adults with Primary Immune Thrombocytopenia
Announcement
argenx SE will present data for VYVGART® (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) and pipeline candidates empasiprubart and adimanebart at the 2026 American Academy of Neurology (AAN) Annual Meeting in Chicago from April 18-22, 2026.
AI Summary
argenx SE will present clinical and real‑world data for VYVGART® (IV efgartigimod alfa‑fcab and SC VYVGART HYTRULO®: efgartigimod alfa with hyaluronidase) along with pipeline candidates empasiprubart and adimanebart at the 2026 American Academy of Neurology (AAN) Annual Meeting in Chicago, April 18–22, 2026. The company plans oral and poster presentations that highlight new trial results and supporting analyses across myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP).
Notable data to be shared include positive Phase 3 ADAPT OCULUS results showing VYVGART’s potential as the first targeted treatment for ocular MG, ADAPT SERON findings demonstrating efficacy and safety in gMG patients without detectable AChR antibodies, and new biomarker, real‑world, and post‑hoc analyses supporting use in CIDP. Early proof‑of‑concept results from the ARGX‑119 Phase 1b trial of adimanebart in DOK7 congenital myasthenic syndrome will also be presented, showing favorable safety and functional improvements.
Read Announcement- Drug:
- VYVGART (efgartigimod alfa)
- Announced Date:
- February 26, 2026
- Indication:
- For Adults with Primary Immune Thrombocytopenia
Announcement
argenx SE announced positive topline results from the Phase 3 ADAPT OCULUS study evaluating VYVGART® (efgartigimod alfa and hyaluronidase-qvfc) in adults with ocular myasthenia gravis (oMG).
AI Summary
argenx SE announced positive topline results from the Phase 3 ADAPT OCULUS study evaluating VYVGART (efgartigimod alfa and hyaluronidase‑qvfc) in adults with ocular myasthenia gravis (oMG). The study met its primary endpoint (p = 0.012). These results support argenx’s planned supplemental Biologics License Application (sBLA) submission to the U.S. Food and Drug Administration to expand the VYVGART label to include oMG.
ADAPT OCULUS is the first registrational study to specifically evaluate a targeted treatment for patients living with oMG. The trial used the Myasthenia Gravis Impairment Index (MGII), a validated measure with an ocular‑specific subdomain that assesses the two key symptoms of oMG: diplopia (double vision) and ptosis (drooping eyelid).
VYVGART was well tolerated and showed a favorable safety profile in oMG patients, consistent with prior studies, and no new safety concerns were identified. Full study data will be presented at an upcoming medical meeting.
Read Announcement- Drug:
- VYVGART (efgartigimod alfa)
- Announced Date:
- January 13, 2026
- Target Action Date:
- May 10, 2026
- Indication:
- For Adults with Primary Immune Thrombocytopenia
Announcement
argenx SE announced that The application has been granted a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2026.
AI Summary
argenx announced that the U.S. Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) for VYVGART® (efgartigimod alfa-fcab) IV to treat adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis (gMG). The application was granted Priority Review and has a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2026.
The sBLA is supported by data from the Phase 3 ADAPT SERON study, which included patients across MuSK+, LRP4+, and triple seronegative subgroups. The trial met its primary endpoint (p=0.0068), showing a statistically significant and clinically meaningful 3.35-point average improvement in MG-ADL score at week 4 versus placebo. Benefits persisted across treatment cycles and patient subgroups.
VYVGART was generally well tolerated in the study with no new safety concerns identified. If approved, this decision could expand treatment options for patients with seronegative gMG who have limited choices today. argenx will continue its dialogue with the FDA during review.
Read Announcement- Drug:
- VYVGART (efgartigimod alfa)
- Announced Date:
- January 13, 2026
- Indication:
- For Adults with Primary Immune Thrombocytopenia
Announcement
argenx SE announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for VYVGART® (IV: efgartigimod alfa-fcab) for the treatment of adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis (gMG).
AI Summary
argenx announced the U.S. Food and Drug Administration has accepted for priority review a supplemental Biologics License Application (sBLA) for VYVGART® (IV: efgartigimod alfa-fcab) to treat adults with acetylcholine receptor antibody (AChR‑Ab) seronegative generalized myasthenia gravis (gMG). The application has a PDUFA target action date of May 10, 2026. Priority review signals the FDA will review the filing on an accelerated timeline because the treatment could address a significant unmet need for these patients.
The sBLA is supported by Phase 3 ADAPT SERON results (n=119), which met the primary endpoint (p=0.0068). At week 4, VYVGART produced a clinically meaningful 3.35‑point improvement in the Myasthenia Gravis Activities of Daily Living (MG‑ADL) score versus placebo. Benefits were observed across MuSK+, LRP4+ and triple seronegative subgroups. VYVGART was generally well tolerated, with a safety profile consistent with previous experience and no new safety concerns reported.
Read Announcement- Drug:
- VYVGART (efgartigimod alfa)
- Announced Date:
- November 5, 2025
- Indication:
- For Adults with Primary Immune Thrombocytopenia
Announcement
argenx SE announced that Health Canada has issued a Notice of Compliance authorizing VYVGART SC (efgartigimod alfa injection) as a monotherapy for the treatment of adult patients with active chronic inflammatory demyelinating polyneuropathy (CIDP).
AI Summary
argenx SE announced that Health Canada has granted a Notice of Compliance for VYVGART SC (efgartigimod alfa injection) as a monotherapy to treat adult patients with active chronic inflammatory demyelinating polyneuropathy (CIDP). The once-weekly, 20- to 30-second subcutaneous injection comes in a prefilled syringe, giving patients the option to self-administer or get help from a caregiver or healthcare professional at home, on the go, or in a clinic.
This approval marks the first novel, targeted CIDP therapy in over 30 years and the first—and only—neonatal Fc receptor blocker authorized in Canada for this condition. It is based on results from the global ADHERE study involving 322 patients. In ADHERE, 69% of participants showed clinical improvement in strength and function, and there was a 61% reduction in relapse risk compared to placebo (p < 0.0001). Nearly all patients chose to continue treatment in the open-label extension, confirming the therapy’s promise in a field long reliant on immunoglobulin products.
Read Announcement- Drug:
- VYVGART (efgartigimod alfa)
- Announced Date:
- October 29, 2025
- Indication:
- For Adults with Primary Immune Thrombocytopenia
Announcement
argenx SE announced the presentation of new data further highlighting the efficacy and safety of VYVGART® (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) across generalized myasthenia gravis (gMG) patient populations at the 2025 American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting (AANEM) and Myasthenia Gravis Foundation of America (MGFA) Scientific Session in San Francisco from October 29 – November 1, 2025.
AI Summary
argenx SE announced it will present new efficacy and safety data for VYVGART® (IV efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) at the 2025 AANEM Annual Meeting and MGFA Scientific Session in San Francisco from October 29 to November 1, 2025. The results cover multiple generalized myasthenia gravis (gMG) patient populations, including seronegative, adolescent, and real-world cohorts.
Key findings from the Phase 3 ADAPT SERON trial show statistically significant improvements in MG-ADL scores for acetylcholine receptor antibody (AChR-Ab) seronegative patients, supporting a broad role for pathogenic IgGs in gMG. Interim ADAPT Jr data in adolescents (ages 12–17) demonstrated similar reductions in total IgG and AChR-Ab levels to adults, with a favorable safety profile. A real-world claims analysis found that over 70% of VYVGART-treated patients reduced glucocorticoid use meaningfully while maintaining clinical benefit.
Final results from the ADAPT-SC+ extension revealed that about 60% of patients achieved minimal symptom expression (MSE), and 88% of those sustained MSE for at least four weeks. Across all studies, VYVGART maintained a consistent safety profile with no new concerns.
Read Announcement- Drug:
- VYVGART (efgartigimod alfa)
- Announced Date:
- October 15, 2025
- Indication:
- For Adults with Primary Immune Thrombocytopenia
Announcement
argenx SE a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, will present data for VYVGART® (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) and pipeline candidate empasiprubart at the 2025 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and Myasthenia Gravis Foundation of America (MGFA) Scientific Session in San Francisco from October 29-November 1, 2025.
AI Summary
argenx SE, a global immunology company, will present data for VYVGART® (intravenous efgartigimod alfa-fcab and subcutaneous Hytrulo) and its pipeline candidate empasiprubart at the 2025 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and the Myasthenia Gravis Foundation of America (MGFA) Scientific Session in San Francisco, October 29–November 1, 2025.
Highlights include pivotal ADAPT SERON results and interim ADAPT Jr data for VYVGART in generalized myasthenia gravis, alongside real-world evidence and long-term safety data showing sustained patient benefits. More than 40 abstracts will cover neuromuscular diseases such as chronic inflammatory demyelinating polyneuropathy, multifocal motor neuropathy, and idiopathic inflammatory myopathies.
argenx will also present Phase 3 study designs for empasiprubart in CIDP (EMVIGORATE and EMNERGIZE) and Phase 2 efficacy and safety data in multifocal motor neuropathy, underscoring its commitment to bring new therapies to people with severe autoimmune disorders.
Read Announcement- Drug:
- VYVGART (efgartigimod alfa)
- Announced Date:
- August 25, 2025
- Indication:
- For Adults with Primary Immune Thrombocytopenia
Announcement
argenx SE announced positive topline data from the pivotal ADAPT SERON study of VYVGART® (IV: efgartigimod alfa-fcab).
AI Summary
argenx SE announced positive topline results from its pivotal ADAPT SERON study of VYVGART® (IV: efgartigimod alfa-fcab) in adult AChR-Ab seronegative generalized myasthenia gravis patients. The trial met its primary endpoint (p=0.0068), showing a statistically significant and clinically meaningful improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores versus placebo.
This global Phase 3 trial showed benefits across all three seronegative subtypes—MuSK+, LRP4+ and triple negative. VYVGART was well tolerated, matching the known safety profile with no new concerns. The randomized, double-blind, placebo-controlled study enrolled 119 patients worldwide, administering four once-weekly infusions followed by a five-week follow-up.
Based on these data, argenx plans to submit a supplemental Biologics License Application to the U.S. FDA by the end of 2025 to expand the VYVGART label to include adult AChR-Ab seronegative gMG patients.
Read Announcement- 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
Efgartigimod FDA Regulatory 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:
- August 17, 2026
- Indication:
- To reduce pathogenic immunoglobulin G (IgG)
Announcement
argenx SE announced positive topline results from the ALKIVIA Phase 3 study evaluating VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with autoimmune myositis.
Read Announcement- 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.
Read Announcement
Efgartigimod alfa and hyaluronidase-qvfc FDA Regulatory Events
Efgartigimod alfa and hyaluronidase-qvfc is a drug developed by argenex for the following indication: Thyroid Eye Disease.
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 alfa and hyaluronidase-qvfc
- Announced Date:
- June 3, 2026
- Indication:
- Thyroid Eye Disease
Announcement
argenx SE 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.
AI Summary
argenx SE said it will present new data on VYVGART across autoimmune rheumatic diseases at the EULAR 2026 Congress in London from June 3-6. The company highlighted results in myositis from the ALKIVIA+ open-label extension study, which followed patients from a prior Phase 2 trial through 52 weeks. The data suggest efgartigimod may lead to lasting, meaningful clinical improvement while maintaining a consistent safety profile.
In Sjogren’s disease, data from the 48-week RHO+ extension study showed that patients kept responding after switching to biweekly dosing based on disease activity scores. The response was measured with the CRESS composite endpoint, which tracks several signs of benefit across the disease.
argenx also reported a cross-study safety analysis showing that efgartigimod was well tolerated across multiple autoimmune diseases and dosing methods. The company said these findings support further study of VYVGART in chronic, antibody-driven rheumatic conditions.
Read Announcement- Drug:
- efgartigimod alfa and hyaluronidase-qvfc
- Announced Date:
- December 15, 2025
- Indication:
- Thyroid Eye Disease
Announcement
argenx SE announced that the Phase 3 UplighTED studies evaluating efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with moderate to severe thyroid eye disease (TED) will be discontinued.
AI Summary
argenx SE announced that it will discontinue the Phase 3 UplighTED studies testing efgartigimod subcutaneous (efgartigimod alfa and hyaluronidase‑qvfc) in adults with moderate to severe thyroid eye disease (TED). An Independent Data Monitoring Committee recommended stopping the trials for futility after reviewing a pre‑specified interim analysis of unblinded 24‑week data. The company said the decision follows that recommendation and noted that efgartigimod showed a favorable safety and tolerability profile with no new safety signals identified.
argenx expressed disappointment and empathy for patients with TED. After study close‑out and database lock, the company will perform a comprehensive analysis to better understand the trial results and any biological insights that could inform future TED research. Data from the studies are planned to be shared at a future medical meeting. The trials had been assessing proptosis response and other clinical measures at week 24.Read Announcement
ARGX-119 FDA Regulatory 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.
Read Announcement
VYVGART Hytrulo FDA Regulatory 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.
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ALKIVIA FDA Regulatory 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
