argenx to unveil its ‘Vision 2030: Taking Breakthrough Science to 50,000 Patients’ during its Upcoming R&D Day on July 16, 2024
17 Juin 2024 - 7:00AM
R&D Day presentations to include recent Phase
2 datasets in Sjogren’s disease (efgartigimod) and multifocal motor
neuropathy (empasiprubart) that support advancement to Phase 3
development
Next wave of innovative pipeline candidates to be
introduced highlighting long-term commitment to transform
autoimmunity
Decision to not advance development of
efgartigimod in PC-POTS based on Phase 2 ALPHA data
June 17, 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 it will host an
R&D day on Tuesday, July 16, 2024 at 8:30am ET in New York City
to unveil its ‘Vision 2030: Taking Breakthrough Science to 50,000
Patients’ and provide updates from across its current and future
clinical pipeline.
"argenx today is better positioned than ever
before to deliver on our commitment to transform the autoimmunity
treatment landscape for patients,” said Tim Van Hauwermeiren, Chief
Executive Officer of argenx. “We have grown from our R&D roots
over the last five years into a true global innovator, pioneering
novel targets into a robust pipeline and delivering safe and
effective first-in-class medicines to more than 10,000 patients
around the world. We look forward to sharing our ‘Vision 2030’, and
outlining how the innovation playbook that brought us here today
will power our growth and evolution as we scale the argenx
innovation ecosystem.”
As part of its ‘Vision 2030’, argenx will
outline its long-term commitment to transform the treatment of
severe autoimmune disease with VYVGART, empasiprubart and its
expanding pipeline of antibody-based therapeutics. This will
include its plans to broaden its leadership within myasthenia
gravis (MG) and chronic inflammatory demyelinating polyneuropathy
(CIDP), advance its next wave of indications through late-stage
development to reach patients, and invest in its organic innovation
engine to bring forward new first-in-class pipeline candidates.
R&D Day Agenda
The R&D Day agenda will include the
following topics:
- Vision 2030:
Bringing breakthrough science to 50,000 Patients
- Blueprint for
Innovation: Next wave of first-in-class immunology
targets
- Leadership in
FcRn: Broad opportunity of efgartigimod in severe
autoimmune disease
- Topline Phase 2 RHO data in
Sjogren’s disease
- Preview of Phase 2/3 ALKIVIA study
in immune-mediated myopathies
- Expansion of MG opportunity through
label-enabling studies, including seronegative MG
- Pioneering C2
Development: Next pipeline-in-a-product opportunity with
empasiprubart
- Phase 2 ARDA data in multifocal
motor neuropathy (MMN)
- Preview of Phase 2 studies in
delayed graft function and dermatomyositis
- Introduction of fourth
indication
- Sustainable Commercial
Engine: Scaling global commercial footprint to support
‘Vision 2030’
Featured Speakers
argenx management and scientific leadership will
be joined by external key opinion leaders who will discuss the
current disease and treatment burden associated with Sjogren’s
disease and MMN, as well as the potential for efgartigimod and
empasiprubart as innovative treatments in these indications.
- Prof. Simon Bowman, PhD FRCP,
Institute of Inflammation and Ageing, University of Birmingham
- Dr. Patrick Kwon, MD, Clinical
Associate Professor, Neurology, NYU Grossman School of
Medicine
PC-POTS Update
Results from the Phase 2 ALPHA study of
efgartigimod in post-COVID-19-mediated postural orthostatic
tachycardia syndrome (PC-POTS) show that treated patients had no
clinically meaningful improvement compared to placebo on the total
Malmö POTS symptom (MaPS) score and COMPASS31. The observed safety
and tolerability profile of efgartigimod in the ALPHA study was
consistent with previous clinical trials. argenx will not move
forward with development in PC-POTS and plans to prioritize
resources to the nearly 50 active clinical trials in its expanding
pipeline.
Webcast Information
Information will be shared leading up to the
R&D Day on the event website at
https://argenx2024rdday.q4ir.com, including the agenda, supporting
materials, and a link to the live audio webcast. A replay of the
webcast will be available on the website approximately one hour
after the conclusion of the event and will be archived for 90
days.
Upon conclusion of the webcast event, in-person
attendees will be invited to attend an interactive poster
session.
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, globally in
the U.S., Japan, Israel, the EU, the UK, China and Canada. 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, X/Twitter, Instagram,
Facebook, and YouTube.
For further information, please
contact:
Media:Ben
Petokbpetok@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,”
“goals,” “plans,” or “will,” and include statements argenx makes
regarding its plans to unveil its ‘Vision 2030’ at an upcoming
R&D day and the planned agenda of such R&D day; its ‘Vision
2030’ and its long-term commitment to transform the treatment of
severe autoimmune diseases with VYVGART, empasiprubart and its
expanding pipeline of antibody-based therapeutics; certain plans
for future growth and evolution, including by (i) broadening its
leadership within MG and CIDP and (ii) advancing its next wave of
indications through late-stage development to reach patients, and
scaling of its innovation ecosystem, including by investing in its
organic innovation engine to bring forward new first-in-class
pipeline candidates; the innovative potential for efgartigimod and
empasiprubart for certain indications; certain results or previews
of its clinical studies and potential opportunities thereof; its
commercial engine and its goal to reach more than 50,000 patients
by 2030; its goal to transform the autoimmunity treatment landscape
for patients; the Phase 2 results from the ALPHA study of
efgartigimod in PC-POTS; its plans to prioritize resources to
active clinical trials; 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 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 in products and product
candidates; the acceptance of argenx's products and product
candidates by patients as safe, effective and cost-effective; the
impact of governmental laws and regulations on our business;
disruptions caused on our reliance of 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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