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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

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argenx (ARGX) presented significant data at the AAN 2025 Annual Meeting, highlighting the sustained efficacy of VYVGART in treating generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP).

The ADAPT-NXT study showed that 75% of gMG patients achieved sustained improvement, with 56.5% reaching minimal symptom expression. The ADHERE+ data demonstrated VYVGART Hytrulo's long-term efficacy in CIDP patients, with 50% of relapsed patients restabilizing by week 4.

The company also revealed promising first-in-human data for ARGX-119, their third clinical candidate for neuromuscular junction disorders. Additionally, argenx is expanding VYVGART's applications through two Phase 3 studies: ADAPT-SERON for seronegative gMG and ADAPT-OCULUS for ocular MG.

argenx (ARGX) ha presentato dati significativi durante l'Annual Meeting AAN 2025, evidenziando l'efficacia sostenuta di VYVGART nel trattamento della miastenia grave generalizzata (gMG) e della polineuropatia demielinizzante infiammatoria cronica (CIDP).

Lo studio ADAPT-NXT ha dimostrato che il 75% dei pazienti gMG ha raggiunto un miglioramento sostenuto, con il 56,5% che ha ottenuto un'espressione minima dei sintomi. I dati ADHERE+ hanno dimostrato l'efficacia a lungo termine di VYVGART Hytrulo nei pazienti con CIDP, con il 50% dei pazienti in riacutizzazione che si è stabilizzato entro la settimana 4.

L'azienda ha anche rivelato dati promettenti di prima applicazione umana per ARGX-119, il loro terzo candidato clinico per i disturbi della giunzione neuromuscolare. Inoltre, argenx sta ampliando le applicazioni di VYVGART attraverso due studi di Fase 3: ADAPT-SERON per gMG seronegativa e ADAPT-OCULUS per MG oculare.

argenx (ARGX) presentó datos significativos en la Reunión Anual AAN 2025, destacando la eficacia sostenida de VYVGART en el tratamiento de la miastenia grave generalizada (gMG) y la polineuropatía desmielinizante inflamatoria crónica (CIDP).

El estudio ADAPT-NXT mostró que el 75% de los pacientes con gMG logró una mejora sostenida, con el 56,5% alcanzando una expresión mínima de síntomas. Los datos de ADHERE+ demostraron la eficacia a largo plazo de VYVGART Hytrulo en pacientes con CIDP, con el 50% de los pacientes en recaída estabilizándose para la semana 4.

La compañía también reveló datos prometedores de primera aplicación en humanos para ARGX-119, su tercer candidato clínico para trastornos de la unión neuromuscular. Además, argenx está ampliando las aplicaciones de VYVGART a través de dos estudios de Fase 3: ADAPT-SERON para gMG seronegativa y ADAPT-OCULUS para MG ocular.

argenx (ARGX)는 AAN 2025 연례 회의에서 중요한 데이터를 발표하며 VYVGART의 일반화된 중증근무력증(gMG) 및 만성 염증성 탈수초 다발신경병증(CIDP) 치료에서 지속적인 효능을 강조했습니다.

ADAPT-NXT 연구에 따르면 gMG 환자의 75%가 지속적인 개선을 달성했으며, 56.5%는 최소한의 증상 표현에 도달했습니다. ADHERE+ 데이터는 CIDP 환자에서 VYVGART Hytrulo의 장기 효능을 보여주었으며, 재발 환자의 50%가 4주 차에 재안정화되었습니다.

회사는 또한 신경근 접합부 장애를 위한 세 번째 임상 후보인 ARGX-119에 대한 유망한 첫 인간 데이터도 공개했습니다. 추가로, argenx는 gMG 음성 환자를 위한 ADAPT-SERON 및 안구 MG를 위한 ADAPT-OCULUS 두 개의 3상 연구를 통해 VYVGART의 적용 범위를 확장하고 있습니다.

argenx (ARGX) a présenté des données significatives lors de la Réunion Annuelle AAN 2025, mettant en avant l'efficacité soutenue de VYVGART dans le traitement de la myasthénie grave généralisée (gMG) et de la polynévrite démyélinisante inflammatoire chronique (CIDP).

L'étude ADAPT-NXT a montré que 75 % des patients atteints de gMG ont connu une amélioration soutenue, avec 56,5 % atteignant une expression minimale des symptômes. Les données ADHERE+ ont démontré l'efficacité à long terme de VYVGART Hytrulo chez les patients atteints de CIDP, avec 50 % des patients en rechute se stabilisant d'ici la semaine 4.

L'entreprise a également révélé des données prometteuses de première application chez l'homme pour ARGX-119, leur troisième candidat clinique pour les troubles de la jonction neuromusculaire. De plus, argenx élargit les applications de VYVGART à travers deux études de Phase 3 : ADAPT-SERON pour la gMG séronégative et ADAPT-OCULUS pour la MG oculaire.

argenx (ARGX) hat auf dem AAN 2025 Jahresmeeting bedeutende Daten präsentiert, die die anhaltende Wirksamkeit von VYVGART bei der Behandlung von generalisierter Myasthenia gravis (gMG) und chronischer entzündlicher demyelinisierender Polyneuropathie (CIDP) hervorheben.

Die ADAPT-NXT Studie zeigte, dass 75% der gMG-Patienten eine anhaltende Verbesserung erreichten, wobei 56,5% eine minimale Symptomäußerung erreichten. Die ADHERE+ Daten demonstrierten die langfristige Wirksamkeit von VYVGART Hytrulo bei CIDP-Patienten, wobei 50% der rückfälligen Patienten bis zur Woche 4 wieder stabilisiert waren.

Das Unternehmen enthüllte auch vielversprechende erste Daten zu ARGX-119, ihrem dritten klinischen Kandidaten für neuromuskuläre Erkrankungen. Darüber hinaus erweitert argenx die Anwendungen von VYVGART durch zwei Phase-3-Studien: ADAPT-SERON für seronegative gMG und ADAPT-OCULUS für okuläre MG.

Positive
  • 75% of gMG patients showed sustained efficacy in ADAPT-NXT study
  • VYVGART Hytrulo demonstrated significant functional improvements in CIDP patients
  • 50% of relapsed CIDP patients restabilized by week 4 on VYVGART
  • Favorable safety profile maintained across multiple treatment cycles
  • Pipeline expansion with promising ARGX-119 first-in-human data
Negative
  • 3.3% of real-world CIDP patients reported disease worsening on VYVGART Hytrulo

Insights

argenx's new VYVGART data presented at AAN 2025 reinforces the drug's leadership position in both gMG and CIDP markets through impressive long-term efficacy and safety metrics. The ADAPT-NXT data showing 75% of patients maintaining significant symptom improvement over 126 weeks is particularly compelling, as is the 56.5% of patients achieving minimal symptom expression. These results validate VYVGART's durable benefit and flexible dosing options that allow for personalized treatment approaches.

The ADHERE+ long-term CIDP data presented orally strengthens VYVGART Hytrulo's competitive position by demonstrating measurable improvements in functional outcomes, including aINCAT disability scores, grip strength, and I-RODS scale improvements at week 36. Notably, 50% of relapsed patients restabilized by week 4 after restarting treatment, indicating robust and rapid efficacy.

The company's pipeline expansion efforts are strategically sound, with first-in-human data for ARGX-119 (MuSK agonist) supporting development for neuromuscular junction disorders, plus ongoing label expansion studies in ocular and seronegative MG - both representing underserved markets with significant commercial potential.

VYVGART's consistent safety profile across multiple studies further de-risks the franchise, particularly with no observed increase in infections or injection site reactions over nine treatment cycles in the ADAPT-SC+ study. The real-world data showing only 3.3% of CIDP patients reporting disease worsening (from 1,316 patients) provides compelling evidence of effectiveness in clinical practice that should drive continued adoption and market penetration.

The VYVGART data presented at AAN 2025 establishes important clinical benchmarks for treating both gMG and CIDP patients. The ADAPT-NXT findings demonstrate sustained disease control across multiple dosing schedules, allowing for truly individualized treatment approaches - a significant advancement over fixed-interval therapies that often leave patients experiencing breakthrough symptoms.

What's particularly meaningful from a patient management perspective is the durability of response. The data showing consistent MG-ADL improvements maintained over 75% of study visits during the 126-week period represents a paradigm shift in disease control expectations. The achievement of minimal symptom expression in 56.5% of patients translates to meaningful quality of life improvements that patients can actually experience in daily functioning.

For CIDP management, the ADHERE+ results showing significant, measurable functional improvements across multiple assessment tools (aINCAT, grip strength, I-RODS) addresses the critical need for therapies that improve motor function and muscle strength - the core disability drivers in this condition. The rapid restabilization of relapsed patients is clinically significant, potentially reducing disability accumulation during treatment transitions.

The company's strategic expansion into ocular MG and seronegative MG addresses substantial unmet needs. Ocular symptoms can be particularly resistant to conventional therapies, while seronegative patients are often excluded from clinical trials despite experiencing the same disease burden. The early ARGX-119 safety profile supports exploration in congenital myasthenic syndromes, an orphan disease area with virtually no approved treatment options.

  • ADAPT-NXT data demonstrate consistent, sustained disease control across dosing schedules, further supporting individualized VYVGART dosing for gMG patients
  • ADHERE+ oral presentation features long-term CIDP data demonstrating VYVGART Hytrulo’s durable efficacy, sustained functional improvements and favorable safety profile
  • argenx continues to advance a robust neuromuscular pipeline of clinical candidates; first-in-human data of ARGX-119 (MuSK agonist) support pipeline-in-a-product development plan

April 8, 2025, 7:00 AM CET

Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced the presentation of 15 abstracts, including an oral presentation, at the 2025 American Academy of Neurology (AAN) Annual Meeting from April 5 – 9, 2025 in San Diego, CA. The presentations showcase long-term data of VYVGART® (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and hyaluronidase-qvfc) demonstrating sustained disease control of generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) with a favorable safety profile.

argenx also highlighted its commitment to reach the broader MG patient community with two ongoing label expansion studies in ocular myasthenia gravis (oMG) and seronegative MG (snMG). In addition, first-in-human data were presented for the company’s third clinical candidate, ARGX-119 (MuSK agonist), which is being evaluated in disorders of the neuromuscular junction (NMJ), including congenital myasthenic syndromes (CMS).

“The data presented at AAN underscore VYVGART and VYVGART Hytrulo’s differentiated efficacy and safety profile, connecting data from our long-term studies to what matters most to gMG and CIDP patients, which is durable, significant quality of life improvements,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. “The extensive data from ADAPT-NXT reinforce the sustained efficacy in patients living with gMG and showcase the opportunity of individualized VYVGART treatment across fixed cycles or every two- or three-week dosing. Also, our long term ADHERE+ data highlight the strength of VYVGART Hytrulo to meaningfully impact motor function and muscle strength for patients with CIDP. Overall, the data we are sharing at AAN reinforce our commitment to the neuromuscular community and further solidify VYVGART as a leading biologic to redefine patient outcomes.”

VYVGART Sets New Benchmark of Sustained Efficacy and Safety for Patients with gMG

  • Sustained disease control achieved across multiple dosing approaches: ADAPT-NXT Part B data demonstrate clinically meaningful improvements as early as Week 1 with both bi-weekly and every three-week dosing schedules of VYVGART. Over the course of the study (126 weeks), 75% of patients showed sustained efficacy, achieving 2-points or more of improvement in MG activities of daily living (MG-ADL score) during more than 75% of study visits. In addition, more than half (56.5%) of participants achieved minimal symptom expression (MSE) during the study. ADAPT NXT data support multiple options to individualize treatment for patients living with gMG. (Poster P1.004)

  • Consistent efficacy and safety results over nine treatment cycles: Interim results of ADAPT-SC+ demonstrate consistent and repeatable improvements in MG-ADL and MG Quality of Life (MG-QoL) scores in gMG patients treated with VYVGART Hytrulo. There was no observed increase in infections or injection-site reactions over nine cycles of treatment. Also, the proportion of patients able to achieve MSE was consistent across multiple cycles. (Poster P1.005)

VYVGART Hytrulo Delivers Long-term Functional Improvements and Favorable Safety Profile for Patients with CIDP

  • Significant functional improvements and rapid stabilization: ADHERE+ data demonstrate VYVGART Hytrulo delivers long-term clinical efficacy. Study results report functional improvements across aINCAT disability scores (>1-point), grip strength (>17 kPa) and I-RODS scale (>8 points) at week 36 compared to baseline at entry to standard of care withdrawal phase. In addition, the majority of ADHERE patients who relapsed during randomized treatment withdrawal stage, restabilized on VYVGART – 50% as early as week 4. Treatment-emergent adverse events (TEAEs) were consistent with label and no new events, nor increased rate or severity of TEAEs were reported with longer treatment with VYVGART Hytrulo. (Oral Presentation S16.002)

  • Real-world insights on transitioning from IVIg to VYVGART Hytrulo: The ADHERE Phase 4 switch open-label study will build upon the ADHERE registrational trial with new data evaluating the transition of patients from a stable dose of IVIg to VYVGART Hytrulo in a one-week transition period (Poster P10.026). Currently, real-world data of 1,316 CIDP patients (as of Jan. 31, 2025) treated with VYVGART Hytrulo show that 3.3% of patients reported any general CIDP worsening. (Symposium: ITU From Discovery to Practice: FcRn Blockade and its Role in CIDP and gMG)

Pipeline Targets Unmet Needs in Underserved Patient Communities

  • First-in-human Phase 1 study supports continued investigation of ARGX-119: Across multiple and single dosing regimens, data from ARGX-119 show a favorable safety profile with no new safety signals observed, supporting further development as a treatment for patients with disorders of the NMJ. (Poster P10.007)

  • Expansion to Seronegative and Ocular MG: argenx is pursuing label extension for VYVGART to broaden its impact with the MG community, including through two Phase 3 studies for seronegative gMG (ADAPT-SERON) and ocular MG (ADAPT-OCULUS). The ADAPT-SERON study is supported by data from seronegative patients in prior VYVGART studies showing consistent and clinically meaningful MG-ADL improvements, including patients achieving MSE. (Poster P1.029)

Full study details can be found at 2025 American Academy of Neurology Abstract Website

See FDA-approved Important Safety Information below, full Prescribing Information for VYVGART, and full Prescribing Information for VYVGART Hytrulo for additional information.

Important Safety Information

What is VYVGART® (efgartigimod alfa-fcab)?
VYVGART is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).

IMPORTANT SAFETY INFORMATION
Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. VYVGART can cause serious allergic reactions and a decrease in blood pressure leading to fainting.

VYVGART may cause serious side effects, including:

  •  Infection. VYVGART may increase the risk of infection. The most common infections were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.
  • Allergic Reactions (hypersensitivity reactions). VYVGART can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with VYVGART. 
  •  Infusion-Related Reactions. VYVGART can cause infusion-related reactions. The most frequent symptoms and signs reported with VYVGART were high blood pressure, chills, shivering, and chest, abdominal, and back pain.

Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction.

Before taking VYVGART, tell your doctor if you:

  • take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,
  • have received or are scheduled to receive a vaccine (immunization), or
  • have any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding.

What are the common side effects of VYVGART?
The most common side effects of VYVGART are respiratory tract infection, headache, and urinary tract infection. These are not all the possible side effects of VYVGART. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.

Please see the full Prescribing Information for VYVGART and talk to your doctor.

What is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)?
VYVGART HYTRULO is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).
VYVGART HYTRULO is a prescription medicine used for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP)

IMPORTANT SAFETY INFORMATION
Do not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.

VYVGART HYTRULO may cause serious side effects, including:

  • Infection. VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.
  • Allergic Reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab. 
  • Infusion-Related Reactions. VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain.

Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction.

Before taking VYVGART HYTRULO, tell your doctor if you:

  • take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,
  • have received or are scheduled to receive a vaccine (immunization), or
  •  have any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding.

What are the common side effects of VYVGART HYTRULO?
The most common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives.

These are not all the possible side effects of VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.

Please see the full  Prescribing Information for VYVGART HYTRULO and talk to your doctor.

About VYVGART and VYVGART Hytrulo
VYVGART® (efgartigimod alfa fcab) is a first-in-class human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. VYVGART® Hytrulo is a subcutaneous combination of efgartigimod alfa (VYVGART) and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology, which facilitates subcutaneous injection delivery of biologics. VYVGART is approved for generalized myasthenia gravis (gMG) and immune thrombocytopenia (Japan only). VYVGART Hytrulo is approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo may be marketed under different proprietary names in other regions.

About ARGX-119
ARGX-119 is a humanized agonistic monoclonal antibody (mAb) that targets and activates muscle-specific kinase (MuSK) to promote maturation and stabilization of the neuromuscular junction (NMJ). MuSK is a receptor kinase that has a critical role in the structure and function of the NMJ. ARGX-119 is being developed as a potential therapy for patients with neuromuscular disease.

About Generalized Myasthenia Gravis (gMG)
Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months¹, where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population.

About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare and serious autoimmune disease of the peripheral nervous system. Although confirmation of disease pathophysiology is still emerging, there is increasing evidence that IgG antibodies play a key role in the damage to the peripheral nerves. People with CIDP experience fatigue, muscle weakness and a loss of feeling in their arms and legs that can get worse over time or may come and go. These symptoms can significantly impair a person's ability to function in their daily lives. Without treatment, one-third of people living with CIDP will need a wheelchair.

About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedInX/Twitter, InstagramFacebook, and YouTube.

References
1 Behin et al. New Pathways and Therapeutics Targets in Autoimmune Myasthenia Gravis. J Neuromusc Dis 5. 2018. 265-277

For further information, please contact:

Media:

Colin McBean
cmcbean@argenx.com

Investors:

Alexandra Roy (US) 
aroy@argenx.com 

Lynn Elton (EU) 
lelton@argenx.com 

Forward-looking Statements

The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “aim,” “are,” “believe,” “can,” “continue,” “expect,” “may,” and “will” and include statements argenx makes concerning the potential impact of VYVGART, VYVGART Hytrulo and ARGX-119 for patients; the data for VYVGART, VYVGART Hytrulo and ARGX-119 as well as clinical studies, including ADAPT-NXT and ADHERE+; its commitment to reach the broader MG patient community with two ongoing label-expansion in oMG and snMG; its commitment to improve the lives of people suffering from severe autoimmune diseases; its goal to continue to advance a robust neuromuscular pipeline of clinical candidates; its view that first-in-human data of ARGX-119 support pipeline-in a-product development plan; the ability for ADAPT-NEXT to reinforce the sustained efficacy in patients living with gMG and showcase the opportunity of individualized VYVGART treatment; the ability of VYVGART Hytrulo to meaningfully impact motor function and muscle strength for patients with CIDP; its commitment to the neuromuscular community; its commitment to further solidify VYVGART as a leading biologic to redefine patient outcomes; its expectations regarding the ADHERE Phase 4 switch open-label study; its aim to target unmet needs in underserved patient communities; and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx’s clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements; the acceptance of its products and product candidates by its patients as safe, effective and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; its reliance on third-party suppliers, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.


FAQ

What were the key efficacy results from the ADAPT-NXT study for VYVGART in gMG patients?

75% of patients showed sustained efficacy with 2-point or more improvement in MG-ADL score during 75% of study visits, and 56.5% achieved minimal symptom expression over 126 weeks.

How effective was VYVGART Hytrulo in treating CIDP patients according to ADHERE+ data?

ADHERE+ showed significant functional improvements in disability scores, grip strength, and I-RODS scale at week 36, with 50% of relapsed patients restabilizing by week 4.

What new indications is argenx pursuing for VYVGART through Phase 3 trials?

argenx is conducting Phase 3 trials for seronegative gMG (ADAPT-SERON) and ocular MG (ADAPT-OCULUS) to expand VYVGART's label.

What safety profile did ARGX-119 demonstrate in its first-in-human study?

ARGX-119 showed a favorable safety profile across multiple and single dosing regimens, with no new safety signals observed.
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