UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of April 2025
Commission File Number: 001-38097
ARGENX SE
(Translation of registrant’s name into English)
Laarderhoogtweg 25
1101 EB Amsterdam, the Netherlands
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
EXPLANATORY NOTE
On April 8, 2025, argenx SE (the “Company”)
issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
The information contained in this Current Report
on Form 6-K, including Exhibit 99.1, shall be deemed to be incorporated by reference into the Company’s Registration Statements
on Forms S-8 (File Nos. 333-225375, 333-258253, and 333-274721), and to be part thereof from the date on which this Current
Report on Form 6-K is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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ARGENX SE |
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| Date: April 8, 2025 |
By: |
/s/
Hemamalini (Malini) Moorthy |
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Name: Hemamalini (Malini) Moorthy |
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Title: General Counsel |
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Exhibit 99.1
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 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 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:
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.
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