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 2024
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, 2024, 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 F-3 (File No. 333-258251) and 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date on which this Current Report on Form 6-K is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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: March 8, 2024 |
By: |
/s/ Hemamalini (Malini) Moorthy |
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Name: Hemamalini (Malini) Moorthy
Title: General Counsel |
Exhibit 99.1
argenx Delivers on Promise to Transform Patient
Expectations in Autoimmunity at American Academy of Neurology 2024 Annual Meeting
ADHERE data presentation will highlight first
potential innovation for CIDP patients in 30 years
Abstracts
reflect real-world value and consistent efficacy and safety profile associated with long-term use of VYVGART®
and VYVGART® Hytrulo in gMG patients
March 7, 2024, 10:01 pm 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 that eight abstracts, including two oral presentations, featuring
clinical trial and real-world data for VYVGART (efgartigimod alfa-fcab) and VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)
in rare autoimmune diseases will be presented at the American Academy of Neurology (AAN) Annual Meeting, taking place in Denver, CO from
April 13-18, 2024.
“We are opening a new chapter for the VYVGART
portfolio,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. “While VYVGART continues to reach more gMG patients
globally, we are also striving to bring meaningful benefits to people living with CIDP – a community which has been awaiting innovation
for 30 years. We are excited to present a broad set of data at AAN this year that collectively demonstrate how we are delivering on our
promise to transform patients’ lives with innovative treatments.”
Transforming Autoimmunity by Targeting FcRn
Findings from the ADHERE study of VYVGART Hytrulo
in chronic inflammatory demyelinating polyneuropathy (CIDP) will be presented for the first time in an oral presentation during the Clinical
Trials Plenary Session, taking place on Tuesday, April 16, 2024. These positive data from the ADHERE study have been submitted to the
FDA for potential approval of VYVGART Hytrulo in CIDP with a PDUFA target action date of June 21, 2024.
In addition to the full ADHERE data, the AAN presentations
will highlight clinical trial and real-world data showcasing the broad opportunity with VYVGART, a first-in-class neonatal FC receptor
(FcRn) inhibitor, and VYVGART Hytrulo, to deliver significant value to the generalized myasthenia gravis (gMG) patient community by driving
consistent and repeatable improvements across patient subtypes, a favorable and predictable safety profile, and the ability to individualize
treatment across both intravenous and subcutaneous administration and dosing schedules.
| · | Achievement of MSE enables significant quality of life improvements: ADAPT/ADAPT+ demonstrate that
>40% of patients achieve minimal symptom expression (MSE) across both studies. Patients achieving MSE experience quality of life outcomes
comparable to healthy populations, suggesting MSE could be a primary goal of gMG treatment. |
| · | Favorable
safety profile across IgG-mediated autoimmune diseases: A review of safety findings across multiple studies of VYVGART
in IgG-mediated autoimmune diseases showed VYVGART was consistently well tolerated across all indications and doses studied. |
| · | ADAPT NXT evaluated additional individualized dosing regimens for initiating long-term treatment: Data
from Phase 3b ADAPT NXT study will provide important guidance on different treatment regimens, which will allow for additional individualization
of VYVGART treatment |
| · | Potential for tapering of oral corticosteroids (OCS) post-VYVGART initiation: Long-term OCS use
continues to be a significant burden on people living with autoimmune disease and reducing or tapering OCS may alleviate the risk of many
adverse events related to long-term usage. Early insights into OCS utilization post-efgartigimod initiation in gMG patients indicate that
a substantial proportion reduced OCS usage over the first 6 months of treatment. |
| · | Cost-effectiveness
of VYVGART compared to chronic intravenous immunoglobulin (IVIg): Findings from a cost-effectiveness analysis of VYVGART versus
chronic IVIg for the treatment of gMG showed that, over a lifetime, VYVGART provided greater benefit at lowers costs. |
Details for oral and poster presentations at
AAN are as follows:
| Title |
Lead Author |
Presentation |
|
Efficacy, Safety, and Tolerability of Efgartigimod
in Patients With Chronic Inflammatory Demyelinating Polyneuropathy: Results From the ADHERE Trial
|
Jeffrey Allen |
Oral Presentation during Clinical Trial Plenary
Session
Tuesday, April 16, 9:15-11:30 a.m. MT |
|
Real-world Reduction in Oral Corticosteroid Utilization
following Efgartigimod Initiation in Patients Living with Generalized Myasthenia Gravis
|
Neelam Goyal |
Oral Presentation
Wednesday, April 17
3:42 p.m. MT |
|
Cost-effectiveness Analysis of Efgartigimod versus
Chronic Intravenous Immunoglobulin (IVIg) for Treatment of Acetylcholine Receptor Antibody Positive (AChR-Ab+) Generalized Myasthenia
Gravis (gMG) in Canada
|
Zaeem Siddiqi |
Poster Presentation
Monday, April 15
11:45 a.m.-12:45 p.m. MT |
|
Overview of the Safety Profile from Efgartigimod
Clinical Trials in Participants with Diverse IgG-mediated Autoimmune Diseases
|
Tuan Vu |
Poster Presentation
Monday, April 15
11:45 a.m.-12:45 p.m. MT |
|
Long-Term Safety, Tolerability, and Efficacy of
Subcutaneous Efgartigimod PH20 in Participants With Generalized Myasthenia Gravis: Interim Results of the ADAPT-SC+ Study
|
James Howard |
Poster Presentation
Wednesday, April 17
11:45 a.m.-12:45 p.m. MT |
|
Fixed-Cycle and Continuous Dosing of Intravenous
Efgartigimod for Generalized Myasthenia Gravis: Study Design of ADAPT NXT
|
Vera Bril |
Poster Presentation
Wednesday, April 17
11:45 a.m.-12:45 p.m. MT |
|
Achievement of Minimal Symptom Expression and
Effect on Disease-Specific Measures in Acetylcholine Receptor Antibody-Positive Participants With Generalized Myasthenia Gravis Treated
With Efgartigimod in ADAPT/ADAPT+
|
Srikanth Muppidi |
Poster Presentation
Wednesday, April 17
11:45 a.m.-12:45 p.m. MT |
|
Analysis of Serious Infections and Malignancy
Risk in Myasthenia Gravis: a US Claims Database Study
|
Jana Podhorna |
Poster Presentation
Wednesday, April 17
11:45 a.m.-12:45 p.m. MT |
More information on the program is available at AAN.
See Important Safety Information below, full United
States Prescribing Information for VYVGART and full Prescribing Information for VYVGART Hytrulo for additional information.
What is VYVGART® (efgartigimod
alfa-fcab) for intravenous (IV) infusion and what is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous
injection?
VYVGART and VYVGART HYTRULO are both prescription
medicines, each 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. 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 and VYVGART HYTRULO can cause serious allergic reactions
and a decrease in blood pressure leading to fainting
VYVGART and VYVGART HYTRULO may cause serious
side effects, including:
Infection
VYVGART and 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 and 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 and 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 or 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 or 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
and 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 and 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 and the full Prescribing
Information for VYVGART HYTRULO.
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 months,1
where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total
gMG population.1
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
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 and China 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-and-only 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 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 in the U.S., Japan, Israel, the EU, the
UK, Canada and China. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage
experimental medicines within its therapeutic franchises. For more information,
visit www.argenx.com and
follow us on LinkedIn, Twitter, and Instagram.
Contacts
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 “aims,” “committed,”
“expects,” “may,” “will,” “strive” or “anticipate” and include statements
argenx makes concerning the potential impact of VYVGART and VYVGART Hytrulo for CIDP patients;
its promise to transform patients’ lives with innovative treatments; the opportunity with VYVGART and VYVGART Hytrulo to
deliver significant value to the gMG patient community by driving consistent and repeatable improvements; its
expectation that VYVGART and VYVGART Hytrulo reduce maternal IgG antibody levels, thereby
reducing the passive protection to the newborn; 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 development of novel drug therapies, preclinical and
clinical trial and product development activities and regulatory approval requirements, the acceptance of our products and product candidates
by our patients as safe, effective and cost-effective, and the impact of governmental laws and regulations on our business. 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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