argenx同时披露FB102乳糜泻II期阳性与efgartigimod干燥综合征III期UNITY因无效终止

----- tm2627263d1_6k.htm -----
6-K
1
tm2627263d1_6k.htm
FORM 6-K
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
October
2026
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 October 8, 2026, argenx SE (the “
Company
”)
issued two press releases, copies of which are attached hereto as Exhibits 99.1 and 99.2, respectively, and are incorporated by reference
herein.
The information contained in this Current
Report on Form 6-K, including Exhibit 99.1 and 99.2, shall be deemed to be incorporated by reference into the
Company’s Registration Statements on Forms S-8 (File Nos.
333-225375
,
333-258253
,
333-274721
, and
333-292200
), 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the extent not superseded by documents or reports subsequently filed or furnished.
Exhibit
Description
99.1
Press Release
October
8, 2026
99.2
Press Release
October
8, 2026
2
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: October 8, 2026
By:
/s/ Hemamalini (Malini) Moorthy
Name: Hemamalini (Malini) Moorthy
Title: General Counsel
3

----- tm2627263d1_ex99-1.htm -----
EX-99.1
2
tm2627263d1_ex99-1.htm
EXHIBIT 99.1
Exhibit 99.1
argenx Announces Positive Topline Results from
Phase 2 Study of FB102 in Celiac Disease
·
Study met primary endpoint of change from baseline in the ratio of Vh:Cd (p=0.0176)
·
First Phase 2 evidence that blocking CD122 can prevent gluten-induced intestinal damage in people living
with celiac disease
·
argenx plans to advance FB102 into Phase 3 development
October 8, 2026, 7:00 AM CET
Amsterdam,
the Netherlands
– argenx SE (Euronext & Nasdaq: ARGX), a global immunology innovation company, today announced
positive topline results from the Phase 2 study evaluating FB102, a first-in-class CD122 inhibitor, in adults with celiac disease. These
results represent the first clinical readout of FB102 following argenx’s acquisition of Forte Biosciences in August 2026.
Patients
treated with FB102 demonstrated a statistically significant and clinically relevant treatment effect compared to placebo. The study met
its primary endpoint of change from baseline in the ratio of villus height–to–crypt depth (Vh:Cd) at day 78 versus placebo
in adults with celiac disease undergoing a gluten challenge (p=
0.0176). Broad efficacy measures, including intraepithelial lymphocyte
(IEL) density, villus height-to-crypt depth intraepithelial lymphocyte (VCIEL) composite score, and symptoms, were consistent with the
primary endpoint, providing additional evidence of effect across histologic, inflammatory, and clinical measures.
The observed safety profile was consistent with
prior studies and the known safety profile of FB102, with no new safety signals identified.
"These
positive Phase 2 results strengthen our conviction in the potential of FB102 to address a significant unmet need for people living with
celiac disease, where there are currently no approved therapies
,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at
argenx. “The study builds on the Phase 1b trial, providing consistent clinical evidence that CD122 blockade can protect against
gluten-induced intestinal damage and prevent emergence of patient symptoms, even under a more intense gluten challenge, validating CD122
as a promising therapeutic target in celiac disease. Combined with the consistent safety profile observed across studies, these findings
support advancing FB102 into Phase 3 development and further exploring its broader potential across immune-mediated diseases.”
Detailed results from the Phase 2 study will be
shared at an upcoming medical meeting. FB102 continues to be evaluated as a potential treatment in other autoimmune diseases, including
vitiligo and alopecia areata.
FB102-301 Study Design
FB102-301
(
NCT06982963
) is a randomized, double-blind, placebo-controlled, Phase 2 study evaluating FB102 in adults with celiac disease.
The study enrolled 126 patients with confirmed celiac disease who were symptom free on a strict gluten-free diet for at least 12 months.
Participants were randomized (2:2:1) to receive intravenous infusions of FB102 (two dose levels) or placebo while undergoing a controlled,
eight-week oral gluten challenge. The primary endpoint was change from baseline in the ratio of villus height-to-crypt depth (Vh:Cd)
at day 78 versus placebo, aimed at determining whether FB102 protects the intestine from gluten-induced damage over the challenge period.
About Celiac Disease
Celiac disease is a chronic autoimmune condition
triggered by ingesting gluten, a group of proteins found in wheat, barley, and rye. In people with celiac disease, gluten triggers an
immune response that damages the lining of the small intestine. Over time, this damage leads to impaired nutrient absorption and symptoms
that include abdominal pain, bloating, diarrhea, and fatigue. There are no approved medicines to treat celiac disease and the current
standard of care is a strict gluten-free diet. Unintended exposure to gluten through consumer products, like prepackaged foods, cosmetics,
toothpaste, vitamins, and nutritional supplements, is common. Many people living with celiac disease also experience challenges eating
out of the home at restaurants, work, or while traveling, which impacts their quality of life. It is estimated that approximately
1 percent of people worldwide have celiac disease, and studies show the incidence is rising by about 7.5% per year. The burden of symptoms,
growing prevalence, and lack of any approved therapeutic options reinforce the critical need for medications that can address the underlying
causes of intestinal damage and improve symptoms and outcomes in people living with celiac disease.
About FB102
FB102 is an investigational, first-in-class anti-CD122
antibody being studied as a potential treatment for several autoimmune diseases, including celiac disease, vitiligo, and alopecia areata.
CD122 is a key component of IL-2 and IL-15 signaling pathways involved in the activation and maintenance of disease-driving immune cells.
FB102 is designed to block CD122 to selectively modulate IL-2 and IL-15 pathways that cause inflammation while preserving regulatory T-cell
function and immune balance. The U.S. Food and Drug Administration has granted FB102 Fast Track Designation for celiac disease.
About argenx
argenx
is a global immunology innovation 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
,
Instagram
,
Facebook
, and
YouTube
.
This press release contains
inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014).
Media:
Suzanne Johnson
sjohnson@argenx.com
Investors:
Alexandra Roy
aroy@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 generally can be identified
by the use of forward-looking words, such as “aim”, “anticipate”, “aspire”, “believe”,
“can”, “continue”, “could”, “estimate”, “expect”, “entail”, “forecast”,
“future”, “goals”, “hope”, “intend”, “is designed to”, “likely”,
“may”, “might”, “objective”, “plan”, “possible”, “potential”,
“pursue”, “project”, “predict”, “seek”, “should”, “strategy”,
“target”, “will” and other words and terms of similar meaning and expression, including in connection with any
discussion of future operating or financial performance. 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; uncertainties associated with the development of novel drug therapies; preclinical
and clinical trial and product development risks and setbacks; interpretation of argenx’s clinical trial data by regulatory authorities
and argenx’s ability to obtain regulatory approval; the risk that early stage clinical trials may not be predictive of results in
later stage or large scale clinical trials; the occurrence of adverse safety events or participant dropouts; 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; the impact of healthcare regulations, including rules on
reimbursement for argenx’s products; competition in drug discovery, development and commercialization efforts; its reliance on third-party
suppliers, service providers and manufacturers; and instability and conflicts in the regions in which the company has suppliers or markets
for its products. A further list and description of these and other risks, uncertainties, and factors that could cause actual results
to differ materially from those referred to in the forward-looking statements 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 risks and uncertainties, the reader is advised not to place
undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this press
release. 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.

----- tm2627263d1_ex99-2.htm -----
EX-99.2
3
tm2627263d1_ex99-2.htm
EXHIBIT 99.2
Exhibit 99.2
argenx Provides Update on Phase 3 UNITY Study
of Efgartigimod SC in Sjögren's Disease
October 8, 2026, 7:00 AM CET
Amsterdam,
the Netherlands
– argenx SE (Euronext & Nasdaq: ARGX), a global immunology innovation company, today announced
that it will discontinue the Phase 3 UNITY study of efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults
with moderate-to-severe Sjögren's disease.
The decision is based on the recommendation from
an Independent Data Monitoring Committee (IDMC) to stop the study for futility following an interim analysis. The IDMC concluded that
the UNITY study is unable to meet its primary endpoint. Safety was consistent with efgartigimod's established profile and no new safety
signals were identified.
“We are disappointed by this outcome, most
of all for people living with Sjögren's disease, who are still waiting for treatments that fundamentally change the course of their
disease,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. “Sjögren's Disease is one of the most heterogeneous
and complicated diseases in immunology, and unraveling the biology of complex diseases is at the heart of what we do. We will analyze
these data in depth and share what we learn with the Sjögren's community. We are grateful to the patients, families, investigators
and site staff who made this study possible.”
Following study close and database lock, argenx
will conduct a comprehensive analysis of the data to understand the study's outcome and generate insights that may inform future research
in Sjögren's disease.
UNITY
Study Design
UNITY is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study with an open-label extension,
designed to evaluate the efficacy, safety and tolerability of efgartigimod SC in adults with moderate-to-severe Sjögren's disease.
To be eligible, patients had to meet the 2016 ACR/EULAR classification criteria for primary Sjögren's disease, test positive for
anti-Ro/SSA autoantibodies and have moderate-to-severe systemic disease activity (clinESSDAI ≥6) while receiving stable background
standard of care. Patients were randomized 1:1 to receive weekly efgartigimod SC or placebo during the double-blind treatment period.
The primary endpoint was change from baseline in systemic disease activity, as measured by the clinical EULAR Sjögren's Syndrome
Disease Activity Index (clinESSDAI), at Week 48. Key secondary endpoints included the proportion of patients achieving low disease activity
(clinESSDAI <5), responder status on the Sjögren's Tool for Assessing Response (STAR), change in patient-reported symptoms as
measured by the Diary of Sjögren's Symptoms Assessment (DiSSA), and safety and tolerability.
About
Sjögren's Disease
Sjögren's disease is a chronic, slowly progressive, inflammatory systemic autoimmune disease characterized
by immune-mediated destruction of the exocrine glands. It can be severely debilitating and have a negative impact on patient quality
of life, with commonly reported symptoms including dry eyes and mouth, fatigue and joint pain. In addition, a substantial subset of patients
suffer from extraglandular systemic disease. While the presence of anti-Ro and IgG autoantibodies is considered a hallmark of the disease,
its underlying cause is believed to be multifactorial, with environmental triggers leading to autoimmunity and chronic inflammation.
The disease predominantly affects women, with a 9:1 female-to-male incidence ratio. Given its heterogeneous nature, the treatment journey
can be challenging, with long delays and high rates of misdiagnosis.
About
VYVGART
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 to facilitate
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 argenx
argenx
is a global immunology innovation 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
,
Instagram
,
Facebook
, and
YouTube
.
This press release contains
inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014).
Media:
Colin McBean
cmcbean@argenx.com
Investors:
Alexandra Roy
aroy@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 generally can be identified by the use of
forward-looking words, such as “aim”, “anticipate”, “aspire”, “believe”, “can”,
“continue”, “could”, “estimate”, “expect”, “entail”, “forecast”,
“future”, “goals”, “hope”, “intend”, “is designed to”, “likely”,
“may”, “might”, “objective”, “plan”, “possible”, “potential”,
“pursue”, “project”, “predict”, “seek”, “should”, “strategy”,
“target”, “will” and other words and terms of similar meaning and expression, including in connection with any
discussion of future operating or financial performance. 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; uncertainties associated with the development of novel drug therapies; preclinical
and clinical trial and product development risks and setbacks; interpretation of argenx’s clinical trial data by regulatory authorities
and argenx’s ability to obtain regulatory approval; the risk that early stage clinical trials may not be predictive of results in
later stage or large scale clinical trials; the occurrence of adverse safety events or participant dropouts; 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; the impact of healthcare regulations, including rules on
reimbursement for argenx’s products; competition in drug discovery, development and commercialization efforts; its reliance on third-party
suppliers, service providers and manufacturers; and instability and conflicts in the regions in which the company has suppliers or markets
for its products. A further list and description of these and other risks, uncertainties, and factors that could cause actual results
to differ materially from those referred to in the forward-looking statements 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 risks and uncertainties, the reader is advised not to place
undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this press
release. 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.