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argenx Highlights Strategic Priorities for 2022 Initiated global VYVGART (efgartigimod alfa-fcab) commercial launch Expect data from five registrational trials of efgartigimod by first quarter of 2023 Announcing four new

Key Takeaway: argenx Highlights Strategic Priorities for 2022 Initiated global VYVGART (efgartigimod alfa-fcab) commercial launch Expect data from five registrational trials of efgartigimod by first quarter of 2023 Announcing four new efgartigimod indications to be initiated in 2022: mem

Full Press Release Details

argenx Highlights Strategic Priorities for 2022
Initiated global VYVGART (efgartigimod
alfa-fcab) commercial launch
Expect data from five registrational trials
of efgartigimod by first quarter of 2023
Announcing four new efgartigimod indications
to be initiated in 2022: membranous nephropathy, lupus nephritis, Sjogren's syndrome, COVID-19 mediated postural orthostatic tachycardia
Anticipate clinical development programs in
12 autoimmune conditions across four therapeutic franchises by end of 2022
Management to present at 40th Annual
J.P. Morgan Healthcare Conference
the Netherlands - argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the
lives of people suffering from severe autoimmune diseases, today announced its strategic priorities for 2022 and highlighted recent achievements
from its broad immunology pipeline. Additionally, the Company provided financial guidance for 2022.
"We enter 2022 very excited about the year
ahead, having achieved our first FDA approval and initiated our commercial launch of VYVGART in the United States. With these accomplishments,
we are well on our way to realizing our goal to become a leading, multi-product immunology company and believe we have the right team,
a differentiated pipeline, and a sustainable innovation engine to support our vision," commented Tim Van Hauwermeiren, Chief Executive
"Beyond this launch, we are focused on expanding
and accelerating the clinical development of our efgartigimod portfolio. Toward that end, we expect to report data from five registrational
trials by the end of the first quarter of 2023 and to initiate trials in four new indications this year through partnership agreements
with Zai Lab and IQVIA. We believe our leadership in neonatal Fc receptor (FcRn) blockade, along with our robust immunology pipeline,
position 2022 to be a transformational year for argenx," continued Mr. Van Hauwermeiren.
Strategic Priorities
The following strategic priorities for 2022 support
the argenx 2025' vision to become a global, integrated immunology organization:
On track for global commercial launch of VYVGART
for treatment of generalized myasthenia gravis (gMG) across three continents
Topline data expected from five registrational
trials of efgartigimod by first quarter of 2023, which position argenx for multiple potential launches within commercial franchises by
Topline data of SC efgartigimod for pemphigus foliaceous and vulgaris
expected in fourth quarter of 2022
Efgartigimod development portfolio to expand
to ten high-need autoimmune conditions by end of 2022, solidifying argenx's leadership position in FcRn blockade
ARGX-117, a novel C2 inhibitor, has potential
to be second pipeline-in-a-product for multiple autoimmune indications
Continued investment in Immunology Innovation
Program to broaden autoimmune pipeline for sustained value creation opportunities
As of December 31, 2021, argenx had approximately
$2.3 billion in cash, cash equivalents and current financial assets. Based on current plans to fund anticipated operating expenses and
capital expenditures, argenx expects to utilize approximately half of its available cash in 2022. The increased spend will support the
global VYVGART launches, clinical development of efgartigimod and ARGX-117 in 12 total indications, investment in the global supply chain,
and continued focus on pipeline expansion through the Immunology Innovation Program.
40th Annual J.P. Morgan Healthcare
Conference Presentation and Webcast
Mr. Van Hauwermeiren will highlight these
updates in a corporate presentation at the virtual 40th Annual J.P. Morgan Healthcare Conference on Monday, January 10,
2022 at 7:30 a.m. ET. The live webcast of the presentation may be accessed under Investors on the argenx website. A replay will be
available for 30 days following the presentation.
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-and-only FDA approved neonatal Fc receptor blocker, VYVGART (efgartigimod alfa-fcab)
for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines
For further information, please contact:
Forward-looking Statements
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 "believes," "hope,"
"estimates," "anticipates," "expects," "intends," "may," "will,"
or "should" and include statements argenx makes concerning its goal to become a leading, multi-product immunology
company; focus on expansion and acceleration of clinical development of its efgartigimod portfolio; the timing and its expectations with
respect to reporting data from registrational trials and initiate trials in new indications; the intended results of its strategy including
global launch preparation and argenx 2025 vision to become a global, integrated immunology organization; its plans for global commercialization
launch of VYVGART across three continents; expectation of Japan's MAA approval of VYVGART during the first quarter of 2022 and expected
approval by European Medicines Agency of MAA in the second half of 2022; establishment of argenx Canada in the first quarter of 2022 and
preparation for potential Health Canada approval and commercial launch; plans for Medison to file for approval in Israel in second quarter
of 2022, and Zai Lab to file for approval in greater China by mid-2022; partnership agreements expected to be announced in 2022; expectations
with respect to potential commercial franchise launches; development of the efgartigimod portfolio for additional indications; its clinical
development and regulatory plans, including the timing, design and outcome of ongoing and planned clinical trials and preclinical activities
and the timing and outcome of regulatory filings and approvals; its expectations with respect to its use of available cash and liquidity
needs for 2022; and its belief in transformational potential of year 2022. 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.
Last updated: Jan 7, 2022