Latest news with #VYVGARTHytrulo
Yahoo
08-04-2025
- Business
- Yahoo
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
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 INFORMATIONDo 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 INFORMATIONDo 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 HytruloVYVGART® (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 argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit and follow us on LinkedIn, X/Twitter, Instagram, Facebook, and YouTube. References1 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 McBeancmcbean@ Investors: Alexandra Roy (US) aroy@ Lynn Elton (EU) lelton@ 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 in to access your portfolio
Associated Press
07-03-2025
- Health
- Associated Press
argenx Highlights FcRn Leadership with Long-term Data and Transformational Patient Outcomes at the American Academy of Neurology 2025 Annual Meeting
Largest safety data set on FcRn blocking demonstrates consistent, favorable safety profile of VYVGART and VYVGART Hytrulo gMG patients on VYVGART achieve rapid, substantial, and sustained efficacy across multiple dosing regimens, supporting individualized treatment approach ADHERE+ oral presentation builds upon evidence of VYVGART Hytrulo driving improved functional ability in CIDP Amsterdam, the Netherlands – March 7, 2025 – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today 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. 'Our goal is to help people living with rare autoimmune diseases feel and function the way they did before experiencing life with a debilitating condition. This year at AAN, we are sharing more evidence demonstrating the long-term benefits of VYVGART for patients living with gMG and CIDP,' said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. 'Our breadth of data continues to support VYVGART as a leading biologic. It has a proven ability to achieve minimal symptom expression for gMG patients and reduce CIDP symptoms quickly while providing improved functional ability, all with a favorable safety profile. We look forward to engaging in the latest science at AAN to continue pushing the boundaries of helping patients live better.' Abstracts at AAN will highlight real-world and clinical data demonstrating VYVGART's sustained clinical improvements, including consistent functional improvement and a favorable safety profile. In addition, presentations support an individualized treatment approach and the ambition for VYVGART to reach patients earlier in the treatment paradigm. Additional dosing approaches achieve clinical improvements in gMG through 126 weeks: New data from ADAPT-NXT, investigating biweekly or every three-week dosing of VYVGART, demonstrated sustained clinical improvements, including minimal symptom expression (MSE), and consistent long-term safety through 126 weeks. Largest long-term data set of any FcRn blocker in gMG shows sustained safety and efficacy: ADAPT-SC+ analyses of VYVGART Hytrulo demonstrate consistent safety results and sustained efficacy through nine cycles of treatment. Favorable benefit-risk profile in gMG: A comparative effectiveness study of emerging immunomodulatory therapies for patients with gMG shows that Fc receptor blockers, particularly VYVGART, show a more favorable benefit-risk profile. 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. Switch from IVIg to efgartigimod in CIDP: The Phase 4 open-label trial is investigating effective and safe transition from stable IVIg doses to VYVGART Hytrulo within one week after last IVIg dose. Details for oral and poster presentations at AAN are as follows: Title Lead Author Presentation Long-term Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy: Interim Results From The ADHERE+ Study Jeffrey Allen Oral Presentation #002 S:16 Updates on Nerve and Muscle Disorders Monday, April 7 1:12 PM Design of a Phase 3 Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Subcutaneous Efgartigimod PH20 Administered by Prefilled Syringe in Adults with Ocular Myasthenia Gravis Carolina Barnett-Tapia Poster #003 Neighborhood 11 Saturday, April 5 11:45 - 12:45 PM Long-Term Safety and Efficacy of Subcutaneous Efgartigimod PH20 in Adult Participants with Generalized Myasthenia Gravis: Interim Results of the ADAPT-SC+ Study Tuan Vu Poster #005 Neighborhood 11 Saturday, April 5 11:45 - 12:45 PM Fixed Cycle and Every-Other-Week Dosing of Intravenous Efgartigimod for Generalized Myasthenia Gravis: Part B of ADAPT NXT Kelly Gwathmey Poster #004 Neighborhood 11 Saturday, April 5 11:45 - 12:45 PM Hospitalization Outcomes After Efgartigimod Initiation In Patients with Myasthenia Gravis A. Gordon Smith Poster #011 Neighborhood 11 Saturday, April 5 11:45 – 12:45 PM A Retrospective Claims Study to Investigate Safety Risks Associated with Chronic Inflammatory Demyelinating Polyneuropathy and the Mediating Effects of Immunoglobulin Treatments Jana Podhorna Poster #011 Neighborhood 2 Saturday, April 5 11:45 AM – 12:45 PM Changes In Nonsteroidal Immunosuppressive Treatment Usage Before and After Efgartigimod Initiation in Patients with Myasthenia Gravis Pushpa Narayanaswami Poster #015 Neighborhood 11 Saturday, April 5 11:45 – 12:45 PM Combined Analyses of Participants with Anti-Acetylcholine Receptor Seronegative Generalized Myasthenia Gravis Treated with Efgartigimod Across Clinical Studies Vera Bril Poster #029 Neighborhood 11 Saturday, April 5 11:45 - 12:45 PM Evaluating the Comparative Effectiveness of Emerging Immunomodulatory Therapies for Patients with Generalized Myasthenia Gravis A. Gordon Smith Poster #033 Neighborhood 11 Saturday, April 5 11:45 – 12:45 PM Study Design of Subcutaneous Efgartigimod PH20 in Juvenile Generalized Myasthenia Gravis Abigail Schwaede Poster #009 Neighborhood 6 Monday, April 7 5:00 - 6:00 PM Phase 3 Trial Investigating Impact of Intravenous Efgartigimod in Anti-Acetylcholine Receptor Antibody Negative Generalized Myasthenia Gravis James F. Howard Jr Poster #032 Neighborhood 11 Monday, April 7 5:00 - 6:00 PM First-in-Human Dose Selection and Pharmacokinetics, Safety, Tolerability, and Immunogenicity of ARGX-119, an Agonist Antibody for Human Muscle-Specific Kinase Tonke van Bragt Poster #007 Neighborhood 2 Tuesday, April 8 5:00-6:00 PM Treatment Impact of Efgartigimod PH20 SC in I-RODS Daily Activity Assessment in Patients with Chronic Inflammatory Demyelinating Polyneuropathy: Post hoc Analysis of the Registrational ADHERE Study Richard Lewis Poster #025 Neighborhood 11 Tuesday, April 8 5:00 PM – 6:00 PM Investigating the Pharmacodynamics, Injection Speed, and Usability of Subcutaneous Efgartigimod PH20 Administration Using a Prefilled Syringe Tiffany Hargraves Poster #026 Neighborhood 11 Tuesday, April 8 11:45 - 12:45 PM Transition From Intravenous Immunoglobulin to Efgartigimod PH20 SC in Participants with Chronic Inflammatory Demyelinating Polyneuropathy: A Phase 4 Study in Progress Yessar Hussain Poster #026 Neighborhood 11 Tuesday, April 8 5:00 PM – 6:00 PM COVID-19 Vaccination Response in Participants Across Clinical Trials Investigating Efgartigimod PH20 SC Ali A. Habib Poster #029 Neighborhood 11 Tuesday, April 8 11:45 - 12:45 PM More information on the program is available at 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 VYVGART is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. It is the first approved FcRn blocker in the United States, EU, China and Canada for the treatment of adults with generalized myasthenia gravis (gMG) who are anti- acetylcholine receptor (AChR) antibody positive and in Japan for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). About VYVGART Hytrulo VYVGART Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the reduction of circulating IgG. It is the first-approved FcRn blocker administered by subcutaneous injection. VYVGART Hytrulo is the proprietary name in the U.S. for subcutaneous efgartigimod alfa and recombinant human hyaluronidase PH20. It may be marketed under different proprietary names following approval in other regions. About Generalized Myasthenia Gravis 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 population1. About Chronic Inflammatory Demyelinating Polyneuropathy 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 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 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 LinkedIn, X/Twitter, Instagram, Facebook, 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: Ben Petok [email protected] Investors: Alexandra Roy (US) Lynn Elton (EU) 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,' 'engage,' 'may,' and 'will' and include statements argenx makes concerning the potential impact of VYVGART and VYVGART Hytrulo for patients; the data for VYVGART and VYVGART Hytrulo that will be presented at the upcoming AAN Annual Meeting; its goal of pushing the boundaries of helping patients live better; the planned agenda for the AAN Annual Meeting; its data showing VYVGART and VYVGART Hytrulo as one of the leading biologics for gMG and CIDP; 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 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.
Yahoo
27-02-2025
- Business
- Yahoo
argenx Reports Full Year 2024 Financial Results and Provides Fourth Quarter Business Update
$737 million in fourth quarter and $2.2 billion in full year global product net sales Received positive CHMP recommendation for VYVGART pre-filled syringe for gMG, enabling launch in the EU; FDA PDUFA (gMG and CIDP) on track for April 10 10 Phase 3 and 10 Phase 2 studies across pipeline ongoing in 2025, positioning for next wave of growth Recognized one-time tax benefit of $725 million related to previously unrecognized deferred tax assets Management to host conference call today at 2:30 PM CET (8:30 AM ET) February 27, 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 reported financial results for the full year 2024 and provided a fourth quarter business update. "In 2024, we significantly expanded our global patient reach with VYVGART, surpassing 10,000 patients across three indications,' said Tim Van Hauwermeiren, Chief Executive Officer of argenx. 'We are extremely proud of the initial launch efforts of VYVGART Hytrulo in CIDP, where the strength of our data has driven early positive feedback from both patients and physicians. This execution has contributed to our position of financial strength as we expect to become a profitable company in 2025. We are now more committed than ever to advancing our mission of transforming the autoimmune treatment landscape by investing in innovation, and leading with our science. Momentum across our business is off to a strong start this year as we continue to execute on our Vision 2030. We are focused on maximizing commercial opportunities in gMG and CIDP, including advancing the pre-filled syringe in multiple regions, expanding our label in MG, and deepening relationships within the CIDP community to explore VYVGART Hytrulo's long-term potential. With an expansive pipeline, we are also excited to drive forward 10 Phase 3 and 10 Phase 2 studies in 2025 across efgartigimod, empasiprubart, and ARGX-119, to unlock significant opportunities in high unmet need areas.' Advancing Vision 2030 argenx has established its commercial and clinical strategic priorities to advance 'Vision 2030'. Through this vision, argenx aims to treat 50,000 patients globally with its medicines, secure 10 labeled indications across all approved medicines, and advance five pipeline candidates into Phase 3 development by 2030. Expand the global VYVGART opportunity and launch VYVGART SC as a pre-filled syringe VYVGART® (IV: efgartigimod alfa-fcab and SC: efgartigimod alfa and hyaluronidase-qvfc) is a first-in-class FcRn blocker approved in three indications, including generalized myasthenia gravis (gMG) globally, primary immune thrombocytopenia (ITP) in Japan, and chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S., Japan, and China. argenx plans to drive commercial growth by expanding into new regions; innovating on the patient experience by advancing its pre-filled syringe (PFS) in multiple markets for CIDP and gMG in 2025 and autoinjector in 2027; and reaching broader MG populations with ongoing studies in seronegative, ocular, and pediatric MG. Generated global product net sales (inclusive of both VYVGART and VYVGART SC) of $737 million in fourth quarter and $2.2 billion in full year of 2024 Multiple VYVGART regulatory submissions completed for gMG, including: Ministry of Food and Drug Safety approved VYVGART (IV) for gMG in South Korea through Handok Inc. Therapeutic Goods Association (TGA) approved VYVGART (IV and SC) for gMG in Australia Four key regulatory decisions on approval for PFS on track for 2025: Received positive CHMP recommendation for approval of PFS for gMG, enabling launch in the EU FDA review ongoing of PFS for gMG and CIDP with Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2025 PFS decision on approval for CIDP in the EU expected in first half of 2025 PFS decision on approval for gMG and CIDP expected in Japan and Canada in second half of 2025 Evidence generation through Phase 4 and label-enabling studies in MG, CIDP and ITP: Topline results expected in second half of 2025 for seronegative gMG (ADAPT-SERON) and first half of 2026 for ocular and pediatric MG (ADAPT-OCULUS, JR) Phase 4 switch study ongoing in CIDP to inform treatment decisions when switching patients on IVIg to VYVGART SC ADVANCE-NEXT topline results expected in second half of 2026 to support FDA submission of VYVGART IV for primary ITP Execute 10 registrational and 10 proof-of-concept studies across efgartigimod, empasiprubart and ARGX-119 to advance the next wave of launches argenx continues to demonstrate breadth and depth within its immunology pipeline, advancing multiple first-in-class product candidates with potential across high-need indications. argenx is solidifying its leadership in FcRn biology with efgartigimod, complement inhibition with empasiprubart and in the role of MuSK at the neuromuscular junction with ARGX-119. Efgartigimod Development Efgartigimod is being evaluated in 15 severe autoimmune diseases (including MG, CIDP, and ITP), exploring the significance of FcRn biology across neurology and rheumatology indications, as well as new therapeutic areas. Registrational ALKIVIA study ongoing evaluating three myositis subsets (immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and dermatomyositis (DM)); topline results expected in second half of 2026 Two registrational UplighTED studies ongoing in thyroid eye disease (TED); topline results expected in second half of 2026 Registrational UNITY study ongoing in primary Sjögren's disease; topline results expected in 2027 Proof-of-concept studies ongoing in lupus nephritis (LN), systemic sclerosis (SSc) and antibody mediated rejection (AMR); topline results expected in LN in fourth quarter of 2025, SSc in second half of 2026, and AMR in 2027 Next nominated indications include autoimmune encephalitis (AIE) and one that is undisclosed Empasiprubart Development Empasiprubart is currently being evaluated in four diseases, including registrational studies in multifocal motor neuropathy (MMN) and CIDP and proof-of-concept studies in delayed graft function (DGF) and DM. Registrational EMPASSION study ongoing in MMN evaluating empasiprubart head-to-head versus IVIg; topline results expected in second half of 2026 Registrational EMVIGORATE study in CIDP evaluating empasiprubart head-to-head versus IVIg expected to start in first half of 2025 Proof-of-concept studies ongoing in DGF and DM; topline results expected for DGF in second half of 2025 and for DM in first half of 2026 ARGX-119 Development ARGX-119 is being evaluated in congenital myasthenic syndromes (CMS), amyotrophic lateral sclerosis (ALS), and spinal muscular atrophy (SMA). Phase 1b proof-of-concept study ongoing in CMS; topline results expected in second half of 2025 Phase 2a proof-of-concept study ongoing in ALS; topline results expected in first half of 2026 SMA proof-of-concept study on track to start in 2025 Advance four new pipeline molecules and generate sustainable value through continued investment in Immunology Innovation Program argenx continues to invest in its Immunology Innovation Program (IIP) to drive long-term sustainable pipeline growth. Through the IIP, four new pipeline candidates have been nominated, including: ARGX-213, targeting FcRn and further solidifying argenx's leadership in this new class of medicine; ARGX-121, a first-in-class molecule targeting IgA; ARGX-109, targeting IL-6, which plays an important role in inflammation, and ARGX-220, a first-in-class sweeping antibody for which the target has not yet been disclosed. Phase 1 results expected for ARGX-109 in second half of 2025 and for ARGX-213 and ARGX-121 in first half of 2026 Don deBethizy to retire as non-executive director, Chair of the Remuneration Committee, and Vice Chair of the Company's Board of Directors, effective May 27, 2025. Mr. deBethizy has served as a non-executive director since 2015. He will be succeeded by Ana Cespedes as Chair of the Remuneration Committee and Tony Rosenberg as Vice Chair of the Board of Directors. 'I would like to express my deep gratitude to Don for his significant contributions during his tenure with argenx. He has been a true champion of our culture, guiding us through several key milestones on our growth journey, while supporting our entrepreneurial spirit and commitment to innovation.' commented Mr. Van Hauwermeiren. FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS argenx SE UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS Three Months Ended Twelve Months Ended December 31 December 31 (in thousands of $ except for shares and EPS) 2024 2023 2024 2023 Product net sales $ 736,968 $ 374,351 $ 2,185,883 $ 1,190,783 Collaboration revenue 1,443 32,486 4,348 35,533 Other operating income 22,809 11,003 61,808 42,278 Total operating income 761,220 417,840 2,252,039 1,268,594 Cost of sales $ (72,656) $ (39,477) $ (227,289) $ (117,835) Research and development expenses (297,228) (306,373) (983,423) (859,492) Selling, general and administrative expenses (285,945) (208,826) (1,055,337) (711,905) Loss from investment in a joint venture (2,350) (1,788) (7,644) (4,411) Total operating expenses (658,179) (556,464) (2,273,693) (1,693,643) Operating profit/(loss) $ 103,041 $ (138,624) $ (21,654) $ (425,049) Financial income $ 39,095 $ 40,308 $ 157,509 $ 107,386 Financial expense (704) (280) (2,464) (906) Exchange (losses)/gains (54,923) 37,418 (48,211) 14,073 Profit/(loss) for the period before taxes $ 86,509 $ (61,178) $ 85,180 $ (304,496) Income tax benefit/(expense) $ 687,652 $ (37,994) $ 747,860 $ 9,443 Profit/(loss) for the period $ 774,161 $ (99,172) $ 833,040 $ (295,053) Profit/(loss) for the period attributable to: Owners of the parent $ 774,161 $ (99,172) $ 833,040 $ (295,053) Weighted average number of shares outstanding used for basic profit/loss per share 60,517,968 59,118,827 59,855,585 57,169,253 Weighted average number of shares outstanding used for diluted profit/loss per share 65,661,428 59,118,827 65,177,815 57,169,253 Basic profit/(loss) per share (in $) $ 12.79 $ (1.68) $ 13.92 $ (5.16) Diluted profit/(loss) per share (in $) $ 11.79 $ (1.68) $ 12.78 $ (5.16) DETAILS OF THE FINANCIAL RESULTS Total operating income for the three and twelve months ended December 31, 2024 was $761 million and $2,252 million, respectively, compared to $418 million and $1,269 million for the same periods in 2023, and mainly consists of: Product net sales of VYVGART and VYVGART SC for the three and twelve months ended December 31, 2024 were $737 million and $2,186 million, respectively, compared to $374 million and $1,191 million for the same periods in 2023. Collaboration revenue for the three and twelve months ended December 31, 2024 was $1 million and $4 million, respectively, compared to $32 million and $36 million for the same periods in 2023. Collaboration revenue for 2024 mainly relates to our collaboration with Zai Lab in China. Other operating income for the three and twelve months ended December 31, 2024 was $23 million and $62 million, respectively, compared to $11 million, and $42 million for the same periods in 2023. The other operating income primarily relates to research and development tax incentives and payroll tax rebates. Total operating expenses for the three and twelve months ended December 31, 2024 were $658 million and $2,274 million, respectively, compared to $556 million and $1,694 million for the same periods in 2023, and mainly consists of: Cost of sales for the three and twelve months ended December 31, 2024 was $73 million and $227 million, respectively, compared to $39 million and $118 million for the same periods in 2023. The cost of sales was recognized with respect to the sale of VYVGART and VYVGART SC. Research and development expenses for the three and twelve months ended December 31, 2024 were $297 million and $983 million, respectively, compared to $306 million and $859 million for the same periods in 2023. The expenses mainly relate to: the clinical development and expansion of efgartigimod in 15 severe autoimmune diseases including MG, CIDP and ITP the ramp-up of studies for our development of empasiprubart into MMN, DGF, DM and CIDP the investments for ARGX-119 in proof-of-concept studies ongoing in ALS and CMS other discovery and preclinical pipeline candidates Selling, general and administrative expenses for the three and twelve months ended December 31, 2024 were $286 million and $1,055 million, respectively, compared to $209 million and $712 million for the same periods in 2023. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to global commercialization of the VYVGART franchise, and personnel expenses. Financial income for the three and twelve months ended December 31, 2024 was $39 million and $158 million, respectively, compared to $40 million and $107 million for the same periods in 2023. Exchange losses for the three and twelve months ended December 31, 2024 were $55 million and $48 million respectively, compared to exchange gains of $37 million and $14 million for the same periods in 2023. Exchange gains or losses are mainly attributable to unrealized exchange rate gains or losses on the cash, cash equivalents and current financial assets position in Euro. Income tax benefit The Company recorded a deferred tax benefit of $802 million for the year ended December 31, 2024 of which $725 million relates to a one-time non-recurring recognition of previously unrecognized deferred tax assets existing as of December 31, 2023. This recognition results from the Company's determination, in the fourth quarter of 2024, that it was probable that future taxable profits will be available for use of unrecognized deferred tax assets. Three Months Ended Twelve Months Ended December 31 December 31 (in millions of $) 2024 2023 2024 2023 Current tax (expense)/benefit $ (25) 12 (54) (12) Deferred tax benefit/(expense) 713 (50) 802 21 Income tax benefit/(expense) $ 688 (38) 748 9 Profit for the period of the three and twelve months ended December 31, 2024 was $774 million and $833 million, respectively, compared to a loss of $99 million and $295 million over the prior periods. On a per weighted average share basis, the basic profit per share was $13.92 for the year ended December 31, 2024, compared to a basic loss per share of $5.16 for the year ended December 31, 2023. FINANCIAL GUIDANCE Based on its current operating plans, argenx expects its combined research and development and selling, general and administrative expenses in 2025 to be approximately $2.5 billion. EXPECTED 2025 FINANCIAL CALENDAR May 8, 2025: Q1 2025 financial results and business update May 27, 2025: Annual General Meeting of Shareholders in Amsterdam, the Netherlands July 31, 2025: Half Year and Second Quarter 2025 Financial Results and Business Update October 30, 2025: Q3 2025 financial results and business update CONFERENCE CALL DETAILS The full year 2024 financial results and business update will be discussed during a conference call and webcast presentation today at 2:30 pm CET/8:30 am ET. A webcast of the live call and replay may be accessed on the Investors section of the argenx website at Dial-in numbers: Please dial in 15 minutes prior to the live call. Belgium 32 800 50 201France 33 800 943355Netherlands 31 20 795 1090United Kingdom 44 800 358 0970United States 1 800 715 9871 Japan 81 3 4578 9081Switzerland 41 43 210 11 32 This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014). About argenx argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit and follow us on LinkedIn, X/Twitter, Instagram, Facebook, and YouTube. For further information, please contact: Media:Ben Petokbpetok@ Investors:Alexandra Roy (US)aroy@ Lynn Elton (EU)lelton@ 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 'advance,' 'aim,' 'believe,' 'continue,' 'drive,' 'expand,' 'expect,' 'plan,' 'position,' 'start,' and 'strive' and include statements argenx makes regarding its expected profitability in 2025; its mission to transform the autoimmune treatment landscape by investing in innovation and its goal to lead in science; its focus on maximizing commercial opportunities in gMG and CIDP, including by advancing PFS in multiple regions, expanding its label in gMG and deepening relationships within the CIDP community; its plan to unlock significant opportunities in high unmet need areas; its long-term commitments, including its Vision 2030 goals of treating 50,000 patients globally with its medicines, securing 10 labeled indications across all approved medicines, and advancing five pipeline candidates into Phase 3 development by 2030; its plans to drive commercial growth by expanding VYVGART into new regions, advance its PFS in multiple markets for CIDP and MG in 2025 and autoinjector in 2027, and reach broader MG populations with ongoing studies in seronegative, ocular, and pediatric MG; the advancement of anticipated clinical development, data readouts and regulatory milestones and plans, including: (1) four key regulatory decisions on approval for PFS expected in 2025; (2) PFS decision on approval for gMG and CIDP expected in Japan and Canada in second half of 2025 and for CIDP expected in the EU in first half of 2025; and (3) ongoing evidence generation through Phase 4 and label-enabling studies in MG, CIDP and ITP, including topline results for seronegative gMG expected in second half of 2025 and those for ocular and pediatric MG expected in first half of 2026, ongoing Phase 4 switch study in CIDP, and ongoing ADVANCE-NEXT confirmatory study of VYVGART IV in primary ITP with topline results expected in second half of 2026; its plans to execute 10 registrational and 10 proof-of-concept studies across efgartigimod, empasiprubart and ARGX-119 in 2025 to advance the next wave of launches; its plans to develop efgartigimod, including: (1) the ongoing registrational ALKIVIA study evaluating IMNM, ASyS, and DM, with topline results expected in second half of 2026; (2) two ongoing registrational UplighTED studies in TED, with topline results expected in second half of 2026; (3) Registrational UNITY study in primary Sjögren's disease, with topline results expected in 2027; (4) ongoing proof-of-concept studies in LN, SSc, and AMR, with topline results expected in fourth quarter of 2025, second half of 2026, and 2027, respectively; and (5) the next nominated indications of AIE and one undisclosed disease to enter clinical studies; its plans to develop empasiprubart, including: (1) registrational EMPASSION study in MMN, with topline results expected in second half of 2026; (2) registrational EMVIGORATE study in CIDP, expected to start in first half of 2025; and (3) proof-of-concept studies in DGF and DM, with topline results expected in second half of 2025 and first half of 2026, respectively; its plans to develop ARGX-119, including: (1) proof-of-concept study in CMS, with topline results expected in second half of 2025; (2) Phase 2a proof-of-concept study in ALS, with topline results expected in first half of 2026; and (3) SMA proof-of-concept study, expected to start in 2025; the expected start and timeline of Phase 1 studies of ARGX-109 in second half of 2025 and ARGX-213 and ARGX-121 in first half of 2026; the expected change from Mr. deBethizy to Ms. Cespedes as the Chair of the Remuneration Committee; the potential of its continued investment in its IIP to drive long-term sustainable pipeline growth; its future financial and operating performance, including its anticipated research and development, selling, general and administrative expenses for 2025; 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 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.
