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Exhibit 99.1
argenx Announces Positive Topline Results from
Phase 3 ADAPT OCULUS Trial of VYVGART in Ocular Myasthenia Gravis
| · | Study
met primary endpoint (p-value = 0.012) |
| · | First
registrational study to specifically evaluate a targeted treatment for patients living with
ocular MG |
| · | Results
support planned Supplemental Biologics License Application (sBLA) submission to U.S. Food
and Drug Administration (FDA) to expand label into oMG |
Regulated Information – Inside Information
February 26, 2026, 6:30 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 positive topline results from the Phase 3 ADAPT OCULUS study evaluating VYVGART® (efgartigimod alfa and
hyaluronidase-qvfc) in adults with ocular myasthenia gravis (oMG).
ADAPT OCULUS met its primary endpoint (p-value=0.012),
showing that patients living with oMG and treated with VYVGART demonstrated statistically significant improvement from baseline in Myasthenia
Impairment Index (MGII) Patient Reported Outcome (PRO) ocular scores at Week 4 compared to placebo. In the overall population, mean change
from baseline in patients treated with VYVGART was a 4.04 point improvement in MGII PRO versus a mean change of 1.99 MGII PRO score in
patients treated with placebo. Patients treated with VYVGART experienced a marked reduction of key ocular symptoms: diplopia (double
vision) and ptosis (drooping of the upper eyelids).
“Ocular myasthenia gravis significantly
impacts patients’ daily lives, affecting vision, independence and the ability to do routine tasks, such as work or drive a car.
Yet today, there are no approved targeted medicines for this disease,” said Carolina Barnett-Tapia, M.D., Ph.D., Associate Professor
of Medicine (Neurology) at the University of Toronto. “The improvements observed with VYVGART in the OCULUS trial offer hope to
the thousands of myasthenia gravis patients with ocular involvement.”
VYVGART was well tolerated and had a favorable safety profile in patients
with oMG, consistent with prior studies. No new safety concerns were identified.
“ADAPT OCULUS is the first registrational
study specifically designed to evaluate a targeted therapy for ocular myasthenia gravis,” said Luc Truyen, M.D., Ph.D., Chief Medical
Officer of argenx. “Ocular MG has been historically under-studied and represents a significant unmet need in the MG community.
These positive results deliver on our patient-centered approach to drug development and bring us one step closer to our vision of delivering
a targeted, transformative treatment option to as many MG patients as possible and ensuring no patient is left behind.”
Data from the ADAPT OCULUS study will be presented
at an upcoming medical meeting.
About the ADAPT OCULUS Study Design
ADAPT OCULUS is a Phase 3, randomized, double-blind,
placebo-controlled, parallel-group design study evaluating the efficacy and safety of VYVGART SC administered by prefilled syringe in
adult patients with ocular MG (MGFA Class I) (n=141) across North America, Europe and Asia-Pacific. In Part A, randomized
participants (1:1) received four once-weekly injections of efgartigimod PH20 SC or placebo PH20 SC followed by a 4-week follow-up. In Part B,
open-label extension, participants received 2 cycles of four once-weekly efgartigimod injections with a 4-week interval between
cycles. Additional cycles from Cycle 3 onward could start ≥1 week after the last administration of the previous cycle, based on clinical
status.
The primary endpoint was the change from baseline
in Myasthenia Gravis Impairment Index (MGII) (patient-reported outcome [PRO] subcomponent) ocular score at week 4 (day 29) compared to
placebo in Part A. Enrolled participants were either seropositive or seronegative for AChR-Ab, and MGFA Class I with
only ocular muscle weakness as determined by an MGII (PRO) ocular score of ≥6 with at least 2 ocular items with a score of ≥2.
Participants were on a stable dose of gMG treatment prior to randomization, including acetylcholinesterase inhibitors, corticosteroids
or nonsteroidal immunosuppressive drugs.
MGII is a validated measure of disease severity
based on the signs and symptoms of myasthenia gravis and includes an ocular-specific subdomain that evaluates the two key clinical
symptoms of oMG: diplopia and ptosis.
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.
Important Safety Information
What is VYVGART HYTRULO® (efgartigimod
alfa and hyaluronidase-qvfc)?
VYVGART HYTRULO is a prescription medicine
used to treat adults with:
| · | generalized
myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. |
| · | chronic
inflammatory demyelinating polyneuropathy (CIDP). |
It is not known if VYVGART HYTRULO is safe
and effective in children.
IMPORTANT SAFETY INFORMATION
Do not take VYVGART HYTRULO if you are allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. VYVGART
HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
Before taking VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:
| · | have
an infection or fever. |
| · | have
recently received or are scheduled to receive any vaccinations. |
| · | have
any history of allergic reactions. |
| · | have
kidney (renal) problems. |
| · | are
pregnant or plan to become pregnant. It is not known whether VYVGART HYTRULO will harm your
unborn baby. |
| o | Pregnancy
Exposure Registry. There is a pregnancy exposure registry for women who use VYVGART HYTRULO
during pregnancy. The purpose of this registry is to collect information about your health
and your baby. Your healthcare provider can enroll you in this registry. You may also enroll
yourself or get more information about the registry by calling 1-855-272-6524 or going to
VYVGARTPregnancy.com |
| · | are
breastfeeding or plan to breastfeed. It is not known if VYVGART HYTRULO passes into your
breast milk. |
Tell your healthcare provider about all the medicines
you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
VYVGART HYTRULO can cause side effects which
can be serious, including:
| · | Infection. VYVGART
HYTRULO may increase the risk of infection. If you have an active infection, your healthcare
provider should delay your treatment with VYVGART HYTRULO until your infection is gone. Tell
your healthcare provider right away if you get any of the following signs and symptoms of
an infection: fever, chills, frequent and painful urination, cough, pain and blockage or
nasal passages, wheezing, shortness, sore throat, excess phlegm, nasal discharge. |
| · | Allergic
reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions
that can be severe. These reactions can happen during, shortly after, or weeks after your
VYVGART HYTRULO injection. Tell your healthcare provider or get emergency help right away
if you have any of the following symptoms of an allergic reaction: rash, swelling of the
face, lips, throat, or tongue, shortness of breath, hives, trouble breathing, low blood pressure,
fainting. |
| · | Infusion
or injection-related reactions. VYVGART HYTRULO can cause infusion or injection-related
reactions. These reactions can happen during or shortly after your VYVGART HYTRULO injection.
Tell your healthcare provider if you have any of the following symptoms of an infusion or
injection-related reaction: high blood pressure, chills, shivering, chest, stomach, or back
pain. |
The most common side effects of VYVGART HYTRULO
include respiratory tract infection, headache, urinary tract infection, and injection site reactions.
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 FDA at 1-800-FDA-1088.
Please see the full Prescribing
Information for VYVGART HYTRULO and talk to your doctor.
About VYVGART and VYVGART Hytrulo
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 Ocular Myasthenia Gravis (oMG)
Ocular myasthenia gravis (oMG) is a rare and
chronic autoimmune disease characterized by muscle weakness limited to the muscles controlling the eyes and eyelids. Symptoms commonly
include ptosis (drooping eyelids), diplopia (double vision), and fluctuating visual disturbance that can impair daily activities. Approximately
80% of myasthenia gravis (MG) patients initially present with ocular symptoms, and up to 92% experience ocular involvement at some point
during the course of disease. While many progress to generalized myasthenia gravis (gMG), in 15–25% of patients, weakness remains
restricted to the ocular muscles. oMG is driven by pathogenic IgG autoantibodies that disrupt communication at the neuromuscular junction.
Despite the functional and quality-of-life burden associated with persistent ocular symptoms, there are currently no approved targeted
therapies specifically for oMG. Treatment approaches often rely on symptomatic therapies and generalized immunosuppression, underscoring
the need for additional therapeutic options for this distinct MG population.
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, 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 can be identified by the
use of forward-looking terminology, including the terms “advance,” “commit,” “continue,” “develop,”
“potential,” and “will” and include statements argenx makes concerning the potential of VYVGART for oMG patients;
argenx’s vision of delivering a targeted, transformative treatment option to as many MG patients as possible; its expectation that
it will submit a Supplemental Biologics License Application (sBLA) for VYVGART for oMG to the U.S. FDA by end of third quarter 2026;
its commitment to improve the lives of people suffering from severe autoimmune diseases; its plan to present data from the ADAPT OCULUS
study at an upcoming medical meeting; its aim to translate immunology breakthroughs into a world-class portfolio of novel antibody-based
medicines; its commercialization of the first approved neonatal Fc receptor (FcRn) blocker and evaluation of its broad potential in multiple
serious autoimmune diseases; and its advancement of several earlier stage experimental medicines within its therapeutic franchises. 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.
