- 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 INFORMATIONDo
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 INFORMATIONDo
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
HytruloVYVGART® (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 argenxargenx 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.
References1 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 McBeancmcbean@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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