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 February 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 February 20, 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thereof from the date on which this Current Report on Form 6-K is filed, to the extent not superseded by documents or reports subsequently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: February 20, 2024 |
By: |
/s/ Hemamalini (Malini) Moorthy |
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Name: Hemamalini (Malini) Moorthy
Title: General Counsel |
Exhibit 99.1
argenx Announces
FDA Acceptance of Supplemental Biologics License Application
with Priority Review for VYVGART Hytrulo in Chronic Inflammatory
Demyelinating
Polyneuropathy
Prescription
Drug User Fee Act (PDUFA) target action date is June 21, 2024
If approved,
VYVGART® Hytrulo will be the first neonatal Fc receptor (FcRn) blocker to treat CIDP
February 20, 2024, 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 that the U.S. Food and Drug Administration
(FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for VYVGART Hytrulo (efgartigimod alfa and
hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). The application has been granted a
PDUFA target action date of June 21, 2024.
“Today’s
announcement brings us one step closer to delivering the transformative innovation of VYVGART Hytrulo to CIDP patients,” said Luc
Truyen, Chief Medical Officer of argenx. “CIDP is yet another example of an autoimmune disease that has not been well understood,
and for which there has been insufficient innovation for patients. We chose to use a priority review voucher to accelerate review of
our submission because CIDP patients have long been waiting for new treatment options. FDA’s acceptance of the sBLA represents
an important milestone in our continued drive to bring novel treatments for rare, autoimmune diseases, and a significant step forward
for people whose lives have been profoundly impacted by this devastating disease.”
The
sBLA is supported by data from the ADHERE study, the largest clinical trial of CIDP to date,
evaluating the safety and efficacy of subcutaneously administered VYVGART Hytrulo in adults with CIDP. The study met its primary endpoint
(p=0.000039), demonstrating a 61% lower risk of relapse (HR: 0.39 95% CI: 0.25; 0.61) with VYVGART Hytrulo compared to placebo. In the
open-label Stage A of the study, 67% of patients showed evidence of clinical improvement (ECI) following treatment with VYVGART Hytrulo.
Given the mechanism of action of VYVGART Hytrulo as an FcRn blocker, the clinical results established that IgG autoantibodies play a
significant role in the underlying biology of CIDP.
VYVGART Hytrulo
was well-tolerated with a safety profile that is consistent with prior clinical trials and the known profile of VYVGART®.
After completing ADHERE, 99% of eligible patients (226/228) continued to the ADHERE-+ open-label extension study.
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 VYVGART® Hytrulo
(efgartigimod alfa and hyaluronidase-qvfc)
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.
See
FDA-approved Important Safety Information below and full Prescribing Information for
VYVGART Hytrulo for additional information
Important Safety
Information
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).
IMPORTANT SAFETY
INFORMATION
What is the
most important information I should know about VYVGART HYTRULO?
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. More patients on efgartigimod
alfa-fcab vs placebo had below normal levels for white blood cell counts, lymphocyte counts,
and neutrophil counts. The majority of infections and observed lower white blood cell counts
were mild to moderate in severity. Your healthcare provider should check you for infections
before starting treatment, during treatment, and after treatment with VYVGART HYTRULO. Tell
your healthcare provider if you have any history of infections. Tell your healthcare provider
right away if you have signs or symptoms of an infection during treatment with VYVGART HYTRULO
such as 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. If a serious infection occurs, your doctor will
treat your infection and may even stop your VYVGART HYTRULO treatment until the infection
has resolved. |
| • | Undesirable immune reactions (hypersensitivity reactions). VYVGART HYTRULO and
efgartigimod alfa-fcab can cause the immune system to have undesirable reactions such as
rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients
treated with VYVGART HYTRULO. In clinical studies, the reactions were mild or moderate and
occurred within 1 hour to 3 weeks of administration, and the reactions did not lead to VYVGART
HYTRULO discontinuation. Your healthcare provider should monitor you during and after treatment
and discontinue VYVGART HYTRULO if needed. Tell your healthcare provider immediately about
any undesirable reactions to VYVGART HYTRULO. |
Before taking VYVGART
HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:
| • | Have
a history of infection or you think you have an infection. |
| • | Have
received or are scheduled to receive a vaccine (immunization). Discuss with your healthcare
provider whether you need to receive age-appropriate immunizations before initiation of a
new treatment cycle with VYVGART HYTRULO. The use of vaccines during VYVGART HYTRULO treatment
has not been studied, and the safety with live or live-attenuated vaccines is unknown. Administration
of live or live-attenuated vaccines is not recommended during treatment with VYVGART HYTRULO. |
| • | Are
pregnant or plan to become pregnant and are breastfeeding or plan to breastfeed. |
Tell your healthcare
provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements.
What are the
common side effects of VYVGART HYTRULO?
The most common
side effects of efgartigimod alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional
common side effects of 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 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 “plans,” “aims,” “believes,” “continues,”
“hope,” “estimates,” “anticipates,” “expects,” “intends,” “may,”
“will,” “should,” or “commitment” and include statements argenx makes concerning our advancement
towards the delivery of VYVGART Hytrulo to CIDP patients, our continued drive to bring novel treatments for rare, autoimmune diseases,
and our 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 our PDUFA review for VYVGART Hytrulo to CIDP patients,
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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