Drugs / Efgartigimod Alfa
Efgartigimod Alfa
also known as
Efgartigimod · ARGX-113 · EFG · Efgartigimod alfa component of vyvgart hytrulo · Efgartigimod Alfa-Fcab · Efgartigimod alfa-qvfc · efgartigimod alpha · HYTRULO · +2 more
Protein / enzyme biologic targets FCGRT via inhibition
Regulatory milestones approvals, filings & regulatory actions · 16 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed generalized myasthenia gravis 7 milestones | |||||
| Filed | US (FDA) | — | generalized myasthenia gravis | 2022-11-22 | “has accepted for priority review a Biologics License Application (BLA) for SC efgartigimod” argenx.com ↗ |
| Filed | US (FDA) | — | generalized myasthenia gravis | 2022-09-21 | “today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for SC efgartigimod” argenx.com ↗ |
| Filed | China (NMPA) | VYVGART | generalized myasthenia gravis | 2022-07-13 | “Zai Lab Announces Acceptance by China’s NMPA of the BLA for Efgartigimod for Patients with Generalized Myasthenia Gravis” zailaboratory.com ↗ |
| Filed | US (FDA) | — | generalized myasthenia gravis | 2021-03-02 | “Biologics License Application (BLA) for IV efgartigimod for treatment of gMG accepted for review by U.S. Food and Drug Administration (FDA)” argenx.com ↗ “FDA has accepted for review the Biologics License Application (BLA) for intravenous (IV) efgartigimod” argenx.com ↗ “BLA for IV efgartigimod for treatment of gMG accepted for review by FDA” argenx.com ↗ |
| Filed | US (FDA) | — | generalized myasthenia gravis | 2021-01-07 | “BLA for IV efgartigimod for treatment of gMG accepted for review by the U.S. Food and Drug Administration (FDA) in March 2021” argenx.com ↗ “Submitted BLA to FDA for efgartigimod for treatment of gMG” argenx.com ↗ “We've submitted a BLA to the FDA for efgartigimod in gMG” argenx.com ↗ |
| Filed | Japan (PMDA) | — | generalized myasthenia gravis | — | “Japanese Marketing Authorization Application (J-MAA) for efgartigimod accepted for review by Japan’s Pharmaceuticals and Medical Device Agency (PMDA) for generalized myasthenia...” argenx.com ↗ “argenx also submitted and was notified of acceptance of an application for efgartigimod to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) earlier this year.” argenx.com ↗ “Marketing authorization application (MAA) filed in Japan in first quarter of 2023” argenx.com ↗ “Regulatory reviews of SC efgartigimod for gMG ongoing in the U.S., EU and Japan” argenx.com ↗ “J-MAA submitted to Japan’s PMDA and accepted for review” argenx.com ↗ |
| Filed | EU (EMA) | — | generalized myasthenia gravis | — | “A Marketing Authorization Application for efgartigimod for the treatment of gMG is currently under review by the European Medicines Agency (EMA)” argenx.com ↗ |
| Filed polyneuropathy, inflammatory demyelinating, chronic 4 milestones | |||||
| Filed | US (FDA) | VYVGART Hytrulo | polyneuropathy, inflammatory demyelinating, chronic | 2026-01-13 | “FDA decision on CIDP sBLA expected by June 21, 2024: Data from the ADHERE trial were submitted to the U.S. Food and Drug Administration (FDA)” argenx.com ↗ “the U.S. Food and Drug Administration ("FDA") has accepted for priority review a supplemental Biologics License Application ("sBLA")” halozyme.com ↗ “FDA has accepted for priority review a supplemental Biologics License Application (sBLA) for VYVGART®” argenx.com ↗ |
| Filed | China (NMPA) | VYVGART SC | polyneuropathy, inflammatory demyelinating, chronic | — | “In May 2024, the NMPA accepted a supplemental Biologics License Application (sBLA) with priority review for efgartigimod SC in chronic inflammatory demyelinating polyneuropathy (CIDP).” argenx.com ↗ “completed the regulatory submissions of VYVGART® SC for CIDP in Japan, Europe, and China during the second quarter of 2024.” halozyme.com ↗ “In April 2024, Zai Lab submitted an sBLA for efgartigimod SC” zailaboratory.com ↗ |
| Filed | Japan (PMDA) | VYVGART SC | polyneuropathy, inflammatory demyelinating, chronic | — | “completed the regulatory submissions of VYVGART® SC for CIDP in Japan, Europe, and China during the second quarter of 2024.” halozyme.com ↗ |
| Filed | EU (EMA) | VYVGART SC | polyneuropathy, inflammatory demyelinating, chronic | — | “completed the regulatory submissions of VYVGART® SC for CIDP in Japan, Europe, and China during the second quarter of 2024.” halozyme.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (3) | US (FDA) | VYVGART | — | 2024-08-08 – 2026-05-08 | fda.gov ↗ |
| Approved | EU (EMA) | Vyvgart | — | 2022-08-10 | europa.eu ↗ |
| Approved | US (FDA) | VYVGART | — | 2021-12-17 | fda.gov ↗ |
Trials 66 · started per year
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EU approved 2022
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT05927415 | Jul 2023 → Jun 2024 | impaired renal function disease | argenx | Completed | No outcome recorded |
| Phase 1 | NCT05163834 | Nov 2021 → Mar 2022 | — | argenx | Completed | No outcome recorded |
| Phase 1 | NCT04564066 | Aug → Dec 2020 | — | argenx | Completed | No outcome recorded |
| Phase 1 | NCT04073589 | Jul → Sep 2019 | — | argenx | Completed | No outcome recorded |
| Phase 1 | NCT03334084 | Oct 2017 → Sep 2018 | — | argenx | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07011589 | Jul 2026 → Jan 2028 expected | acquired epidermolysis bullosa, recessive dystrophic epidermolysis bullosa | M. Peter Marinkovich | Not yet recruiting | No outcome recorded |
| Phase 221 trials · 1 met primary | ||||||
| Phase 2 | NCT07583641 | Apr 2027 → Jul 2030 expected | autoimmune encephalitis | argenx | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07806916 | Sep 2026 → Jun 2027 expected | Guillain-Barre syndrome | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07822776 | Jun 2026 → Dec 2027 expected | autoimmune encephalitis | Beijing Tongren Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07025330 | Nov 2025 → Mar 2028 expected | immunoglobulin G4-related sclerosing disease | Stanford University | Recruiting | No outcome recorded |
| Phase 2 | NCT06831058 | May 2025 → May 2028 expected | acquired thrombotic thrombocytopenic purpura | University of Minnesota | Recruiting | No outcome recorded |
| Phase 2 | NCT06528392 | Apr 2025 → Dec 2026 expected | stiff-person syndrome | University of South Florida | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06655155 | Nov 2024 → Feb 2027 expected | systemic sclerosis | argenx | Recruiting | No outcome recorded |
| Phase 2 | NCT05701189 | Sep 2024 → Jan 2026 | Guillain-Barre syndrome | Chafic Karam | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06503731 | Aug 2024 → Nov 2027 expected | transplant rejection | argenx | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06497374 | Jul 2024 → Dec 2025 overdue | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Tianjin Medical University General Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06221501 | Feb 2024 → Dec 2026 expected | myasthenia gravis | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06203457 | Nov 2023 → Feb 2025 | Sjogren syndrome | argenx | Completed | No outcome recorded |
| Phase 2 | NCT05918978 | Jun 2023 → Aug 2024 | postural orthostatic tachycardia syndrome | argenx | Terminated | No outcome recorded |
| Phase 2 | NCT05817669 | Apr 2023 → Jan 2024 | Sjogren syndrome | argenx | Completed | No outcome recorded |
| Phase 2 | NCT05810948 | Feb 2023 → Jul 2025 | lupus nephritis | argenx | Completed | No outcome recorded |
| Phase 2 | NCT05810961 | Feb 2023 → Aug 2024 | membranous glomerulonephritis | argenx | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT05633407 | Sep 2022 → Apr 2024 | postural orthostatic tachycardia syndrome | argenx | Completed | No outcome recorded |
| Phase 2 | NCT04280718 | Sep 2020 → Apr 2027 expected | polyneuropathy, inflammatory demyelinating, chronic | argenx | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04281472 | Apr 2020 → May 2023 | polyneuropathy, inflammatory demyelinating, chronic | argenx | Completed | Met primary |
| Phase 2 | NCT03334058 | Oct 2017 → Oct 2020 | pemphigus foliaceus, pemphigus vulgaris | argenx | Completed | No outcome recorded |
| Phase 2 | NCT03102593 | Mar 2017 → Apr 2019 | autoimmune thrombocytopenia | argenx | Completed | No outcome recorded |
| Phase 2/38 trials · 1 met primary | ||||||
| Phase 2/3 | NCT07860021 | Sep 2026 → Dec 2027 expected | stiff-person syndrome | Thomas Jefferson University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT07194850 | Oct 2025 → Oct 2028 expected | autoimmune thrombocytopenic purpura | argenx | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06885762 | Apr 2025 → Jun 2026 overdue | Guillain-Barre syndrome | Zhongming Qiu | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06392386 | Jun 2024 → Sep 2027 expected | generalized myasthenia gravis | argenx | Recruiting | No outcome recorded |
| Phase 2/3 | NCT05523167 | Oct 2022 → Jul 2026 | antisynthetase syndrome, dermatomyositis, immune-mediated necrotizing myopathy | argenx | Completed | Met primary |
| Phase 2/3 | NCT05374590 | Aug 2022 → Sep 2029 expected | generalized myasthenia gravis | argenx | Enrolling by invitation | No outcome recorded |
| Phase 2/3 | NCT05267600 | Jun 2022 → Sep 2024 | bullous pemphigoid | argenx | Completed | No outcome recorded |
| Phase 2/3 | NCT04833894 | Oct 2021 → Mar 2027 expected | generalized myasthenia gravis | argenx | Recruiting | No outcome recorded |
| Phase 325 trials · 5 met primary · 2 missed | ||||||
| Phase 3 | NCT07570316 | Jun 2026 → Jun 2028 expected | Graves disease | argenx | Recruiting | No outcome recorded |
| Phase 3 | NCT07596849 | Jun 2026 → Jun 2028 expected | Graves disease | argenx | Recruiting | No outcome recorded |
| Phase 3 | NCT07231523 | Dec 2025 → Jun 2027 expected | AChR+ myasthenia gravis | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06765161 | Feb 2025 → Jan 2027 expected | myasthenia gravis | Clinique Neuro-Outaouais | Recruiting | No outcome recorded |
| Phase 3 | NCT06684847 | Jan 2025 → Jul 2027 expected | Sjogren syndrome | argenx | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06544499 | Oct 2024 → Jun 2028 expected | primary thrombocytopenia | argenx | Recruiting | No outcome recorded |
| Phase 3 | NCT06558279 | Sep 2024 → Jan 2026 overdue | ocular myasthenia gravis | argenx | Active not recruiting | Met primary |
| Phase 3 | NCT06298552 | Apr 2024 → Jun 2025 overdue | generalized myasthenia gravis | argenx | Active not recruiting | Met primary |
| Phase 3 | NCT06307626 | Mar 2024 → Dec 2025 | disease of orbital part of eye adnexa | argenx | Terminated | No outcome recorded |
| Phase 3 | NCT06307613 | Mar 2024 → Dec 2025 | endocrine exophthalmos | argenx | Terminated | No outcome recorded |
| Phase 3 | NCT05979441 | Sep 2023 → Sep 2028 expected | antisynthetase syndrome, dermatomyositis, immune-mediated necrotizing myopathy | argenx | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT06587867 | Jun 2023 → May 2025 overdue | generalized myasthenia gravis | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 3 | NCT05681481 | Mar 2023 → Mar 2025 | bullous pemphigoid | argenx | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04980495 | Dec 2021 → Aug 2023 | generalized myasthenia gravis | argenx | Completed | No outcome recorded |
| Phase 3 | NCT04812925 | Nov 2021 → Oct 2026 expected | autoimmune thrombocytopenia | argenx | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04598477 | Jul 2021 → Mar 2024 | pemphigus foliaceus, pemphigus vulgaris | argenx | Terminated | No outcome recorded |
| Phase 3 | NCT04818671 | Apr 2021 → Dec 2024 | generalized myasthenia gravis | argenx | Completed | No outcome recorded |
| Phase 3 | NCT04735432 | Feb → Nov 2021 | generalized myasthenia gravis | argenx | Completed | Met primary |
| Phase 3 | NCT04687072 | Dec 2020 → Oct 2023 | autoimmune thrombocytopenia | argenx | Completed | Missed primary |
| Phase 3 | NCT04598451 | Dec 2020 → Aug 2023 | pemphigus foliaceus, pemphigus vulgaris | argenx | Completed | Missed primary |
| Phase 3 | NCT04274452 | Jun 2020 → Sep 2021 | autoimmune thrombocytopenia | argenx | Withdrawn | No outcome recorded |
| Phase 3 | NCT04225156 | Jun 2020 → Mar 2026 | autoimmune thrombocytopenia | argenx | Completed | No outcome recorded |
| Phase 3 | NCT04188379 | Dec 2019 → Feb 2022 | primary thrombocytopenia | argenx | Completed | Met primary |
| Phase 3 | NCT03770403 | Mar 2019 → Jun 2022 | generalized myasthenia gravis | argenx | Completed | No outcome recorded |
| Phase 3 | NCT03669588 | Aug 2018 → Apr 2020 | generalized myasthenia gravis | argenx | Completed | Met primary |
| Phase 45 trials | ||||||
| Phase 4 | NCT07072988 | Sep 2025 → Oct 2027 expected | generalized myasthenia gravis | Centre Hospitalier Universitaire de Nice | Recruiting | No outcome recorded |
| Phase 4 | NCT06909214 | Apr 2025 → Aug 2026 overdue | generalized myasthenia gravis | argenx | Recruiting | No outcome recorded |
| Phase 4 | NCT06860633 | Mar 2025 → Dec 2026 expected | AChR+ myasthenia gravis | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 4 | NCT06637072 | Dec 2024 → Feb 2026 | polyneuropathy, inflammatory demyelinating, chronic | argenx | Completed | No outcome recorded |
| Phase 4 | NCT06688253 | Nov 2024 → Jan 2025 overdue | generalized myasthenia gravis | Rambam Health Care Campus | Not yet recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06827587 | Feb 2025 → Feb 2026 overdue | generalized myasthenia gravis, neuromuscular disease | First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT03457649 Comparator | Sep 2015 → Nov 2016 | — | argenx | Completed | No outcome recorded |
| Phase 2 | NCT07284420 Background | Dec 2025 → Mar 2028 expected | AChR+ myasthenia gravis, generalized myasthenia gravis | argenx | Recruiting | No outcome recorded |
| Phase 2 | NCT06453694 Comparator | Aug 2025 → Dec 2026 expected | optic neuritis | Anastasia Vishnevetsky, MD, MPH | Recruiting | No outcome recorded |
| Phase 2 | NCT02965573 Comparator | Dec 2016 → Oct 2017 | generalized myasthenia gravis | argenx | Completed | No outcome recorded |
| Phase 3 | NCT07217587 Comparator | Jan 2026 → Sep 2027 expected | generalized myasthenia gravis | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 97
| Date | Issuer | Release |
|---|---|---|
| 2026-10-08 | argenx | Results argenx Provides Update on Phase 3 UNITY Study of Efgartigimod SC in Sjögren's Disease argenx.com ↗
The decision is based on the recommendation from an Independent Data Monitoring Committee (IDMC) to stop the study for futility following an interim analysis. |
| 2026-09-29 | argenx | Results argenx Presents New Data at AANEM and MGFA Scientific Session Showcasing Earlier and Sustained Treatment in MG and CIDP with VYVGART and Progress Across its Neuromuscular Pipeline argenx.com ↗
New data show deepening improvement in ocular MG and sustained one-year efficacy in anti-AChR antibody-negative MG – broadening VYVGART's potential to treat all MG patients |
| 2026-08-17 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab and argenx Announce Positive Topline Results from Phase 3 ALKIVIA Trial of Efgartigimod in Autoimmune Myositis zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext & NASDAQ: ARGX), today announced positive topline results from the ALKIVIA Phase 3 study evaluating VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with autoimmune myositis. |
| 2026-08-17 | argenx | Results argenx Announces Positive Topline Results from Phase 3 ALKIVIA Trial of Efgartigimod in Autoimmune Myositis argenx.com ↗
Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology innovation company, today announced positive topline results from the ALKIVIA Phase 3 study evaluating VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with autoimmune myositis. |
| 2026-06-03 | argenx | Results argenx Presents New Efgartigimod Data Showing Long-Term Sustained Patient Benefit in Myositis and Sjogren’s Disease at EULAR 2026 argenx.com ↗
ALKIVIA+ data in myositis indicate efgartigimod provides sustained, clinically meaningful improvements and consistent safety |
| 2026-05-08 | argenx | Regulatory argenx Announces U.S. FDA Approval Expanding VYVGART and VYVGART Hytrulo for Use in All Adult Patients Living with gMG argenx.com ↗
The approved supplemental Biologics License Application (sBLA) expands VYVGART’s indication to include all serotypes of adult patients living with gMG – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative. |
| 2026-04-18 | argenx | Results argenx Brings Neuromuscular Leadership to AAN 2026 with New Data Supporting Broader VYVGART Use Across MG and CIDP argenx.com ↗
ADAPT OCULUS is the first study to evaluate a targeted treatment for ocular MG, demonstrating that VYVGART significantly improves disease symptoms in this underserved patient population |
| 2026-03-06 | argenx | Results argenx to Present New Data at 2026 AAN Annual Meeting that Continue to Transform Patient Outcomes in MG and CIDP and Build Upon Strength of Pipeline argenx.com ↗
Positive results from Phase 3 ADAPT OCULUS study show VYVGART’s potential as the first targeted treatment for patients living with ocular MG |
| 2026-02-26 | argenx | Results argenx Announces Positive Topline Results from Phase 3 ADAPT OCULUS Trial of VYVGART in Ocular Myasthenia Gravis argenx.com ↗
ADAPT OCULUS met its primary endpoint (p-value=0.012), showing that patients living with oMG and treated with VYVGART demonstrated statistically significant improvement from baseline in Myasthenia Impairment Index (MGII) Patient Reported Outcome (PRO) ocular scores at Week 4 compared to placebo. |
| 2026-01-13 | argenx | Regulatory argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART in AChR-Ab Seronegative gMG argenx.com ↗ |
| 2025-12-15 | argenx | Results argenx Provides Update on UplighTED Studies of Efgartigimod SC in Thyroid Eye Disease argenx.com ↗
The decision is based on the recommendation from an Independent Data Monitoring Committee (IDMC) to stop the trials for futility following its review of data from a pre-specified interim analysis. |
| 2025-12-07 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Updates to China’s National Reimbursement Drug List zailaboratory.com ↗
VYVGART® (efgartigimod alfa injection) is renewed for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive; |
| 2025-10-29 | argenx | Results argenx Presents New Data at AANEM and MGFA Highlighting the Strength and Broad Benefit of VYVGART for Myasthenia Gravis Patients argenx.com ↗
VYVGART demonstrated clinically meaningful benefit across all AChR-Ab seronegative gMG subtypes in ADAPT SERON, supporting broad role of pathogenic IgGs in disease activity |
| 2025-08-25 | argenx | Results argenx Announces Positive Topline Results from ADAPT SERON Study of VYVGART in Patients with AChR-Ab Seronegative gMG argenx.com ↗
The study met its primary endpoint (p-value=0.0068), demonstrating that AChR-Ab seronegative gMG patients treated with VYVGART achieved a statistically significant and clinically meaningful improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living) total score compared to placebo. |
| 2025-06-20 | argenx | Regulatory argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy argenx.com ↗
argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the European Commission (EC) approved VYVGART® (efgartigimod alfa) 1000mg 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. |
| 2025-06-11 | argenx | Results argenx Presents New Efgartigimod Data at EULAR 2025 Highlighting Positive Phase 2 Proof-of-Concept Results in Myositis and Sjogren’s Disease argenx.com ↗ |
| 2025-06-10 | argenx | Results argenx Presents New Efgartigimod Data at EULAR 2025 Highlighting Positive Phase 2 Proof-of-Concept Results in Myositis and Sjogren’s Disease argenx.com ↗
ALKIVIA data demonstrate significant improvement in muscle strength and physical function in myositis patients treated with efgartigimod |
| 2025-04-28 | argenx | Regulatory argenx Announces Positive CHMP Opinion for VYVGART (efgartigimod alfa) Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) argenx.com ↗ |
| 2025-04-10 | Halozyme Therapeutics | Regulatory Halozyme Announces FDA Approval of argenx's VYVGART® Hytrulo Prefilled Syringe Co-Formulated with ENHANZE® for Self-Injection for Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy halozyme.com ↗
VYVGART® Hytrulo prefilled syringe for self-injection is approved as a 20-to-30-second subcutaneous injection administered by a patient, caregiver, or healthcare professional. |
| 2025-04-10 | argenx | Regulatory argenx Announces FDA Approval of VYVGART Hytrulo Prefilled Syringe for Self-Injection in Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy argenx.com ↗ |
| 2025-04-08 | argenx | Results argenx Highlights VYVGART Data at AAN 2025 Setting New Standard in Sustained Efficacy and Improved Quality of Life Measures for Patients Living with gMG and CIDP argenx.com ↗
The presentations showcase long-term data of VYVGART® (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) demonstrating sustained disease control of generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) with a favorable safety profile. |
| 2025-03-07 | argenx | Results argenx Highlights FcRn Leadership with Long-term Data and Transformational Patient Outcomes at the American Academy of Neurology 2025 Annual Meeting argenx.com ↗
Long-term effectiveness in CIDP: Interim results from the open-label extension ADHERE+ further build upon the largest clinical data set supporting long-term efficacy, including functional improvement and safety of VYVGART Hytrulo in CIDP. |
| 2024-12-27 | argenx | Regulatory argenx Announces Approval of VYVDURA (efgartigimod alfa and hyaluronidase-qvfc) in Japan for Adults with Chronic Inflammatory Demyelinating Polyneuropathy argenx.com ↗
argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved VYVDURA for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). |
| 2024-11-20 | argenx | Results argenx Advances Clinical Development of Efgartigimod SC in Idiopathic Inflammatory Myopathies argenx.com ↗
The decision to continue clinical development of efgartigimod SC in each of the three myositis subtypes is supported by the efficacy and safety results from the Phase 2 portion of the seamless Phase 2/3 ALKIVIA study. |
| 2024-11-11 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab and argenx Announce Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in China zailaboratory.com ↗
VYVGART Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. |
| 2024-11-11 | argenx | Regulatory argenx and Zai Lab Announce Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy in China argenx.com ↗
VYVGART Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. |
| 2024-10-15 | argenx | Results argenx Highlights Data Showing Patient Impact Across Multiple Immunology Programs at 2024 American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting and Myasthenia Gravis Foundation of America Scientific Sessions argenx.com ↗
The data presented at AANEM continue to demonstrate the significant impact of VYVGART (including VYVGART Hytrulo), the first-in-class neonatal Fc receptor (FcRn) blocker for people living with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). |
| 2024-09-19 | argenx | Results argenx Announces Publication in The Lancet Neurology of Pivotal ADHERE Study Data in Chronic Inflammatory Demyelinating Polyneuropathy argenx.com ↗
69% (221/322) of patients treated with VYVGART Hytrulo, regardless of prior treatment, demonstrated evidence of clinical improvement, including improvements in mobility, function and strength |
| 2024-07-16 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab and argenx Announce Approval of Efgartigimod Alfa Injection (Subcutaneous Injection) for Generalized Myasthenia Gravis in China zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext & Nasdaq: ARGX) today announced that China’s National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC), 1,000mg (5.6ml)/vial indicated as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. |
| 2024-07-16 | argenx | Regulatory argenx and Zai Lab Announce Approval of Efgartigimod Alfa Injection (Subcutaneous Injection) for Generalized Myasthenia Gravis in China argenx.com ↗
argenx SE (Euronext & Nasdaq: ARGX) and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) on July 16, 2024 for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC), 1,000mg (5.6ml)/vial indicated as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. |
| 2024-06-21 | Halozyme Therapeutics | Regulatory Halozyme Announces argenx Receives FDA Approval for VYVGART® Hytrulo Co-Formulated with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy halozyme.com ↗
VYVGART® Hytrulo for CIDP is FDA-approved as a once weekly 30-to-90 second subcutaneous (SC) injection. |
| 2024-06-21 | argenx | Regulatory argenx Announces FDA Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy argenx.com ↗
VYVGART Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. |
| 2024-05-14 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Acceptance of Supplemental Biologics License Application with Priority Review for Efgartigimod Alfa Injection (Subcutaneous Injection) in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in China zailaboratory.com ↗
The CDE granted priority review on May 11, 2024 and Breakthrough Therapy Designation for efgartigimod SC for the treatment of patients with CIDP on September 18, 2023. |
| 2024-04-16 | argenx | Results argenx Data Highlight Evidence that VYVGART and VYVGART Hytrulo Drive Transformative Outcomes for Patients with Debilitating Autoimmune Disease argenx.com ↗
argenx also highlighted clinical trial and real-world data across seven posters and presentations that continue to reinforce VYVGART |
| 2024-03-27 | argenx | Results argenx Advances Clinical Development of Efgartigimod in Primary Sjogren’s Disease argenx.com ↗
Efficacy assessments showed a treatment effect across multiple clinical endpoints, which were also consistent with biomarker data. |
| 2024-03-26 | argenx | Regulatory argenx Announces Approval of VYVGART (efgartigimod alfa) in Japan for Adults with Primary Immune Thrombocytopenia argenx.com ↗ |
| 2024-03-07 | argenx | Results argenx Delivers on Promise to Transform Patient Expectations in Autoimmunity at American Academy of Neurology 2024 Annual Meeting argenx.com ↗
Achievement of MSE enables significant quality of life improvements: ADAPT/ADAPT+ demonstrate that >40% of patients achieve minimal symptom expression (MSE) across both studies. |
| 2024-02-19 | argenx | Regulatory argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy argenx.com ↗
FDA’s acceptance of the sBLA represents an important milestone in our continued drive to bring novel treatments for rare, autoimmune diseases, and a significant step forward for people whose lives have been profoundly impacted by this devastating disease. |
| 2024-01-18 | Halozyme Therapeutics | Regulatory Halozyme Announces argenx Received Approval in Japan for VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) Co-Formulated with ENHANZE® for Generalized Myasthenia Gravis halozyme.com ↗
Today's approval includes the opportunity for patient self-administration of SC VYVGART with ENHANZE at home, adding an additional treatment option for patients. |
| 2024-01-17 | argenx | Regulatory argenx Announces Approval of VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Japan for Generalized Myasthenia Gravis argenx.com ↗ |
| 2023-12-20 | argenx | Results argenx Reports Topline Results from ADDRESS Study of Efgartigimod SC in Pemphigus argenx.com ↗
The ADDRESS results show the proportion of PV patients achieving the primary endpoint of complete remission on a minimal dose of steroids (CRmin) was not significantly different between efgartigimod SC and placebo. |
| 2023-12-12 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces the First Listing of VYVGART® (efgartigimod alfa injection) and Other Updates in China’s National Reimbursement Drug List zailaboratory.com ↗
VYVGART® (efgartigimod alfa injection) is included for the first time in the NRDL for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive; |
| 2023-11-28 | argenx | Results argenx Reports Topline Results from ADVANCE-SC Study of VYVGART Hytrulo in Primary Immune Thrombocytopenia argenx.com ↗
The study did not meet the primary endpoint of a sustained platelet count response in chronic ITP patients. |
| 2023-11-16 | Halozyme Therapeutics | Regulatory Halozyme Announces argenx Receives European Commission Approval of VYVGART® SC with ENHANZE® for Generalized Myasthenia Gravis halozyme.com ↗
Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that argenx received European Commission (EC) approval of VYVGART® SC (efgartigimod alfa and hyaluronidase-qvfc) co-formulated with ENHANZE® for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. |
| 2023-11-16 | argenx | Regulatory argenx Announces European Commission Approval of Subcutaneous VYVGART® (efgartigimod alfa) for Generalized Myasthenia Gravis argenx.com ↗
argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the European Commission (EC) approved SC injectable VYVGART (efgartigimod alfa) as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. |
| 2023-11-01 | argenx | Results argenx Highlights Data Evaluating VYVGART in Neuromuscular Autoimmune Disease at AANEM and MGFA Scientific Sessions argenx.com ↗
Long-term clinical trial and real-world data illustrate VYVGART® drives consistent, repeatable and clinically meaningful responses, including minimal symptom expression (MSE) in generalized myasthenia gravis (gMG) |
| 2023-09-20 | argenx | Regulatory argenx Announces VYVGART (efgartigimod alfa) Authorized for Sale by Health Canada for Generalized Myasthenia Gravis argenx.com ↗
With this regulatory milestone, VYVGART is the first- and-only neonatal Fc receptor (FcRn) blocker authorized for sale in Canada. |
| 2023-09-18 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Obtains Breakthrough Therapy Designation for Efgartigimod Alfa Injection (Subcutaneous Injection) in Patients with Chronic Inflammatory Demyelinating Polyneuropathy in China zailaboratory.com ↗
Zai Lab Obtains Breakthrough Therapy Designation for Efgartigimod Alfa Injection (Subcutaneous Injection) in Patients with Chronic Inflammatory Demyelinating Polyneuropathy in China |
| 2023-09-14 | argenx | Regulatory argenx Announces Positive CHMP Opinion for Subcutaneous Efgartigimod for Generalized Myasthenia Gravis argenx.com ↗
The positive recommendation by the CHMP for the SC injectable formulation of efgartigimod brings us one step closer to broadening our treatment offering for people living with gMG in Europe, |
| 2023-07-17 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab and argenx Report Positive Topline Data from ADHERE Study of VYVGART Hytrulo in Patients with Chronic Inflammatory Demyelinating Polyneuropathy zailaboratory.com ↗
The study met its primary endpoint (p=0.000039), demonstrating a significantly lower risk of relapse with VYVGART Hytrulo compared to placebo. |
| 2023-07-17 | Halozyme Therapeutics | Results Positive Topline Data Reported from argenx's ADHERE Study of VYVGART® Hytrulo with Halozyme's ENHANZE® Drug Delivery Technology in Patients with Chronic Inflammatory Demyelinating Polyneuropathy halozyme.com ↗
The study met its primary endpoint (p=0.000039) demonstrating a significantly lower risk of relapse with VYVGART® Hytrulo compared to placebo. |
| 2023-07-16 | argenx | Results argenx Reports Positive Topline Data from ADHERE Study of VYVGART Hytrulo in Patients with Chronic Inflammatory Demyelinating Polyneuropathy argenx.com ↗
The study met its primary endpoint (p=0.000039), demonstrating a significantly lower risk of relapse with VYVGART Hytrulo compared to placebo. |
| 2023-07-10 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Acceptance by China’s NMPA of the BLA for Efgartigimod Alfa Injection (Subcutaneous Injection) for Patients with Generalized Myasthenia Gravis zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous (SC) injection, 1000mg (5.6ml)/vial) for the treatment of adult patients with generalized myasthenia gravis (gMG). |
| 2023-06-30 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab and argenx Announce Approval of VYVGART® (efgartigimod alfa injection) for Generalized Myasthenia Gravis in China zailaboratory.com ↗
China’s National Medical Products Administration (NMPA) has approved the Biologics License Application (BLA) for VYVGART® (efgartigimod alfa injection) |
| 2023-06-30 | argenx | Regulatory argenx and Zai Lab Announce Approval of VYVGART® (efgartigimod alfa injection) for Generalized Myasthenia Gravis in China argenx.com ↗
This approval by the NMPA for VYVGART, our sixth approval globally, is the first-and-only FcRn blocker available for people living with gMG in China. |
| 2023-06-20 | Halozyme Therapeutics | Regulatory Halozyme Announces argenx Receives FDA Approval for VYVGART® Hytrulo With ENHANZE® for Subcutaneous Use in Generalized Myasthenia Gravis halozyme.com ↗ |
| 2023-06-20 | argenx | Regulatory argenx Announces U.S. Food and Drug Administration Approval of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Generalized Myasthenia Gravis argenx.com ↗
argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) approved VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc). |
| 2023-04-18 | argenx | Results argenx Demonstrates Commitment to Redefining Treatment Goals for Generalized Myasthenia Gravis with Multiple Presentations at American Academy of Neurology 2023 Annual Meeting argenx.com ↗
Long-term treatment, administered in individualized dosing cycles, led to consistent and repeatable reductions in IgG antibody levels and improved clinical outcomes. |
| 2023-03-15 | argenx | Regulatory argenx Announces UK MHRA Approval of VYVGART for the Treatment of Generalized Myasthenia Gravis argenx.com ↗
“We are pleased to announce this latest regulatory approval of VYVGART, another exciting advancement toward our vision of making our innovation available to as many patients as possible," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. |
| 2023-01-27 | argenx | Regulatory argenx Receives Notification of PDUFA Date Extension for SC Efgartigimod argenx.com ↗
The FDA notified argenx on January 26, 2023 that information submitted in connection with the ongoing review of the SC efgartigimod BLA constituted a major amendment and requires an extension to allow sufficient time to review. |
| 2022-11-22 | argenx | Regulatory argenx Announces U.S. FDA Acceptance of Biologics License Application for Subcutaneous Efgartigimod in Generalized Myasthenia Gravis with Priority Review argenx.com ↗
The application has been granted a Prescription Drug User Fee Act (PDUFA) target action date of March 20, 2023. |
| 2022-09-21 | argenx | Regulatory argenx Submits Biologics License Application to U.S. Food and Drug Administration for Subcutaneous Efgartigimod for Treatment of Generalized Myasthenia Gravis argenx.com ↗ |
| 2022-08-11 | argenx | Regulatory argenx Announces European Commission Approval of VYVGART™ (efgartigimod alfa-fcab) for the Treatment of Generalized Myasthenia Gravis argenx.com ↗
argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the European Commission (EC) has granted marketing authorization for VYVGART™ (efgartigimod alfa-fcab) as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. |
| 2022-07-13 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Acceptance by China’s NMPA of the BLA for Efgartigimod for Patients with Generalized Myasthenia Gravis zailaboratory.com ↗ |
| 2022-06-23 | argenx | Regulatory argenx Receives Positive CHMP Opinion for Efgartigimod for the Treatment of Adult Patients with Generalized Myasthenia Gravis in Europe argenx.com ↗
The positive CHMP opinion is a scientific recommendation for marketing authorization, serving as a basis for the EC’s final decision on argenx’s application for efgartigimod. |
| 2022-05-31 | argenx | Regulatory argenx Announces the UK MHRA has Granted Early Access to Efgartigimod for Generalized Myasthenia Gravis argenx.com ↗
argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that efgartigimod, the Company’s neonatal Fc receptor (FcRn) blocker has been awarded a positive scientific opinion by the MHRA under the EAMS. |
| 2022-05-19 | argenx | Results argenx Announces Publication of Translational Data of Efgartigimod in Autoimmune Skin Blistering Diseases argenx.com ↗
The translational data, “FcRn Antagonism Leads to a Decrease of Desmoglein-Specific B Cells: Secondary Analysis of a Phase 2 Study of Efgartigimod in Pemphigus Vulgaris and Pemphigus Foliaceus” were published in the journal Frontiers of Immunology. |
| 2022-05-05 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab Partner argenx Announces Positive Phase 3 Data from ADVANCE Trial of VYVGART® (efgartigimod alfa-fcab) in Adults with Primary Immune Thrombocytopenia zailaboratory.com ↗
In adults with primary ITP, ADVANCE met its primary endpoint demonstrating that a higher proportion of chronic ITP patients receiving VYVGART achieved a sustained platelet count response compared to placebo. |
| 2022-05-04 | argenx | Results argenx Announces Positive Phase 3 Data from ADVANCE Trial of VYVGART® (efgartigimod alfa-fcab) in Adults with Primary Immune Thrombocytopenia argenx.com ↗
ADVANCE met its primary endpoint demonstrating that a higher proportion of chronic ITP patients receiving VYVGART achieved a sustained platelet count response compared to placebo. |
| 2022-04-04 | argenx | Results argenx Presents Interim Results from ADAPT+ Open-Label Extension Study Evaluating VYVGART® (efgartigimod alfa-fcab) in Generalized Myasthenia Gravis at 2022 AAN Annual Meeting argenx.com ↗
Patients who participated in ADAPT+ continued to experience consistent efficacy and safety over a year of treatment, reinforcing the potential benefit this targeted therapy can offer to this community. |
| 2022-03-22 | argenx | Results argenx Announces Positive Topline Phase 3 Data from ADAPT-SC Study Evaluating Subcutaneous Efgartigimod for Generalized Myasthenia Gravis argenx.com ↗
SC efgartigimod achieved the primary endpoint of total IgG reduction from baseline at day 29, demonstrating statistical noninferiority to VYVGART® (efgartigimod alfa-fcab) intravenous (IV) formulation in gMG patients. |
| 2022-01-20 | argenx | Regulatory argenx announces VYVGART™ approval in Japan for the treatment of generalized myasthenia gravis argenx.com ↗
argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved VYVGART™ (efgartigimod alfa) intravenous infusion for the treatment of adult patients with generalized myasthenia gravis (gMG) who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). |
| 2021-12-17 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Partner argenx Announces U.S. Food and Drug Administration (FDA) Approval of VYVGART™ (efgartigimod alfa-fcab) in Generalized Myasthenia Gravis zailaboratory.com ↗ |
| 2021-12-17 | argenx | Regulatory argenx Announces U.S. Food and Drug Administration (FDA) Approval of VYVGART™ (efgartigimod alfa-fcab) in Generalized Myasthenia Gravis argenx.com ↗
argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved VYVGARTô (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. |
| 2021-08-24 | argenx | Regulatory argenx Announces Validation of European Marketing Authorization Application for Efgartigimod in Generalized Myasthenia Gravis argenx.com ↗
argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced that it has submitted, and the European Medicines Agency (EMA) has validated, the marketing authorization application (MAA) for the Company’s investigational FcRn antagonist, efgartigimod, for the treatment of generalized myasthenia gravis (gMG). |
| 2021-06-16 | argenx | Results argenx announces publication of Phase 3 ADAPT trial results of efgartigimod for the treatment of generalized myasthenia gravis in The Lancet Neurology argenx.com ↗
argenx (Euronext & Nasdaq: ARGX), today announced that The Lancet Neurology has published pivotal trial results from the Phase 3 ADAPT trial of efgartigimod, an FcRn antagonist, for the treatment of adults living with generalized myasthenia gravis (gMG). |
| 2021-03-02 | argenx | Regulatory argenx Announces FDA Acceptance of BLA Filing for Efgartigimod for the Treatment of Generalized Myasthenia Gravis argenx.com ↗
argenx today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for intravenous (IV) efgartigimod, the company’s investigational FcRn antagonist and lead product candidate, for the treatment of generalized myasthenia gravis (gMG). |
| 2021-02-02 | argenx | Results argenx Issues Statement Concerning Efgartigimod argenx.com ↗ |
| 2021-01-31 | argenx | Results argenx Announces “GO” Decision in ADHERE Trial of Efgartigimod in Chronic Inflammatory Demyelinating Polyneuropathy Following Interim Analysis argenx.com ↗
The interim analysis achieved the pre-defined threshold for continuation, which was based on response rates seen in precedent clinical trials of current standard of care in CIDP. |
| 2020-10-04 | argenx | Results argenx Presents Additional Efgartigimod Data from Global Phase 3 ADAPT Trial at the Myasthenia Gravis Foundation of America 2020 Scientific Session argenx.com ↗
argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced the presentation of new data from the pivotal Phase 3 ADAPT trial evaluating efgartigimod for the treatment of patients with generalized myasthenia gravis (gMG). |
| 2020-05-25 | argenx | Results argenx Announces Positive Topline Phase 3 ADAPT Trial Results argenx.com ↗
argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced positive topline data from the pivotal ADAPT trial of efgartigimod. |
| 2020-01-08 | argenx | Results argenx Provides Strategic Outlook Advancing Late-Stage Pipeline Towards ‘argenx 2021’ Vision argenx.com ↗
In addition, we’re announcing today positive proof-of-concept data for efgartigimod in PV, our third ‘beachhead’ indication, further demonstrating our initial development strategy of targeting pathogenic autoantibodies and creating commercial opportunities in several therapeutic areas. |
| 2019-12-09 | argenx | Results argenx announces publication of efgartigimod Phase 2 primary immune thrombocytopenia trial results in American Journal of Hematology argenx.com ↗
Efgartigimod was well-tolerated and showed a correlation of reduced IgG levels, increased platelet counts and reduced bleeding in ITP patients |
| 2019-05-27 | argenx | Results argenx announces publication of efgartigimod Phase 2 myasthenia gravis trial results in Neurology argenx.com ↗
We are pleased to have the full results of our Phase 2 trial of efgartigimod in gMG published today in the esteemed, peer-reviewed journal, Neurology. |
| 2018-12-02 | argenx | Results argenx Provides Detailed Data from Phase 2 Clinical Trial of Efgartigimod in Immune Thrombocytopenia and Phase 1/2 Clinical Trial of Cusatuzumab in Acute Myeloid Leukemia argenx.com ↗
Detailed Phase 2 ITP data show clear correlation between IgG reduction, platelet count increase and reduction of bleeding events |
| 2018-09-16 | argenx | Results argenx reports positive topline results from Phase 2 proof-of-concept trial of efgartigimod in primary immune thrombocytopenia argenx.com ↗
Breda, the Netherlands / Ghent, Belgium – argenx (Euronext & Nasdaq: ARGX) today announced positive topline results from its Phase 2 proof-of-concept clinical trial of efgartigimod (ARGX-113) in adult primary immune thrombocytopenia (ITP) patients. |
| 2018-07-23 | argenx | Results argenx announces publication of full data from Phase 1 healthy volunteer study of efgartigimod in Journal of Clinical Investigation argenx.com ↗
The Phase 1 data published in JCI show that the FcRn antagonist efgartigimod was observed to have a favorable tolerability profile and led to a specific, profound and sustained reduction of total immunoglobulin G (IgG) levels. |
| 2018-06-19 | argenx | Results argenx reports interim data from first cohort of Phase 2 proof-of-concept clinical trial of efgartigimod for the treatment of pemphigus vulgaris argenx.com ↗
Disease control was reached in three out of six patients in one week, which was characterized by patients having signs of healing of existing lesions and the absence of new lesions forming. |
| 2018-06-13 | argenx | Results argenx announces data from Phase 1 study of efgartigimod (ARGX-113) subcutaneous formulation demonstrating comparable characteristics to intravenous formulation argenx.com ↗
The data show that at the same dose level the SC formulation was comparable across key measures, including half-life, pharmacodynamics and tolerability, to the intravenous (IV) formulation used in clinical studies to date. |
| 2018-04-23 | argenx | Results argenx to present complete data from the Phase 2 proof-of-concept trial of efgartigimod (ARGX-113) in generalized myasthenia gravis at American Academy of Neurology (AAN) Annual Meeting argenx.com ↗
The data show an early separation between treatment and placebo groups on efficacy scores that persisted for the total duration of the study. |
| 2018-03-25 | argenx | Regulatory argenx announces orphan drug designation for ARGX-113 for the treatment of myasthenia gravis in Europe argenx.com ↗ |
| 2017-12-10 | argenx | Results argenx reports positive topline results from Phase 2 proof-of-concept trial of ARGX-113 (efgartigimod) in generalized myasthenia gravis argenx.com ↗
argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced positive topline results from its Phase 2 proof-of-concept clinical trial of ARGX-113 (efgartigimod) in myasthenia gravis (MG) patients with confirmed generalized muscle weakness. |
| 2017-09-24 | argenx | Regulatory argenx announces orphan drug designation for ARGX-113 for the treatment of myasthenia gravis argenx.com ↗ |
| 2016-11-30 | argenx | Results argenx to provide updates on ARGX-113 and ARGX-110 during American Society of Hematology Annual Meeting argenx.com ↗
showing comparable pharmacodynamics and pharmacokinetic patterns between the lower dose (10 mg/kg) and higher dose (25 mg/kg) |
| 2016-06-28 | argenx | Results argenx announces initial results from Phase 1 multiple ascending dose (MAD) study of ARGX-113 in healthy volunteers argenx.com ↗
argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today announced initial results from its Phase 1 multiple ascending dose (MAD) study of ARGX-113 in healthy volunteers. |
| 2016-01-04 | argenx | Results argenx announces initial results from a Phase 1 single ascending dose study of ARGX-113 in healthy volunteers argenx.com ↗
Initial results show the compound to be safe and well-tolerated across all doses in healthy volunteers. |
| 2014-08-18 | argenx | Results arGEN-X Announces Positive Preclinical Results for ARGX-113 argenx.com ↗
The data proved ARGX-113 to be highly effective in rapidly clearing a tracer antibody from circulation in a dose-dependent manner in non-human primates, thus acting as a surrogate of autoantibody clearance. |
All press releases naming this drug 122 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 122 releases opens the full record — a long page | ||
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 73 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | efgartigimod alfa | “Efgartigimod alfa, a human IgG1 antibody Fc fragment, has demonstrated efficacy and safety in patients with generalised myasthenia gravis.” PMID 39304241 ↗ Oct 2024 |
| Known as | ARGX-113 | “Efgartigimod PH20 (ARGX-113) SC” NCT07583641 ↗ |
| Known as | EFG | “This study is a prospective, multi-center, randomized controlled study to evaluate the efficacy and safety of efgartigimod (EFG) and intravenous immunoglobulin (IVIG) in the...” NCT07231523 ↗ |
| Known as | Efgartigimod | “METHODS: A randomized, double-blind, placebo-controlled first-in-human study was conducted in 62 healthy volunteers to explore single and multiple ascending intravenous doses...” PMID 30040076 ↗ Jul 201864“Efgartigimod is a human IgG1 antibody Fc-fragment, a natural ligand of the neonatal Fc receptor (FcRn), engineered for increased affinity to FcRn, while preserving its...” PMID 31821591 ↗ Dec 2019 “A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.” NCT05523167 ↗ “subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20)” NCT04073589 ↗ “Efgartigimod is an FcRn inhibitor that enhances the catabolism of circulating IgG” NCT07860021 ↗ |
| Known as | Efgartigimod alfa component of vyvgart hytrulo | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297551 ↗ |
| Known as | Efgartigimod Alfa-Fcab | “Drug: Efgartigimod Alfa-Fcab” NCT05701189 ↗ |
| Known as | Efgartigimod alfa-qvfc | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297551 ↗ |
| Known as | efgartigimod alpha | “Patients will receive efgartigimod alpha via intravenous infusion at a dose of 10 mg/kg, each infusion lasting approximately 2 hours, on Week 0, 1, 2 and 3.” NCT06497374 ↗ |
| Known as | HYTRULO | “These patients will receive 1000 mg efgartigimod PH20 SC (VYVGART Hytrulo), every week for 12 weeks (as per Hytrulo's therapeutic guidelines)” NCT07860021 ↗ |
| Known as | Vyvgart | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297551 ↗ |
| Known as | VYVGART Hytrulo | “These patients will receive 1000 mg efgartigimod PH20 SC (VYVGART Hytrulo), every week for 12 weeks (as per Hytrulo's therapeutic guidelines)” NCT07860021 ↗ |
| Action | Inhibit | “Efgartigimod blocks FcRn, preventing IgG recycling, and causing targeted IgG degradation.” PMID 31821591 ↗ Dec 20191“IgG receptor FcRn large subunit p51 antagonist” CHEMBL4297551 ↗ |
| Modality | Protein / enzyme biologic | “Efgartigimod is a human IgG1 antibody Fc-fragment” PMID 31821591 ↗ Dec 2019 |
| Route | Intravenous | “four weekly intravenous infusions of either placebo (N = 12) or efgartigimod” PMID 31821591 ↗ Dec 2019 |
| Target | FCGRT | “IgG receptor FcRn large subunit p51 antagonist” CHEMBL4297551 ↗ |