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 March 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 March 7, 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 Form 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Report on Form 6-K is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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.
| |
ARGENX SE |
| |
|
|
| Date: March 7, 2025 |
By: |
/s/ Hemamalini (Malini) Moorthy |
| |
|
Name: |
Hemamalini (Malini) Moorthy |
| |
|
Title: |
General Counsel |
Exhibit
99.1
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 www.aan.com/events/annual-meeting-abstracts#subnav.
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 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:
Ben
Petok
Bpetok@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,” “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.
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