Amsterdam, the Netherlands

$398 million in first quarter global net product sales
FDA review ongoing for CIDP sBLA with PDUFA target action date of June 21, 2024
Management to host conference call today at 2:30 PM CET (8:30 AM ET)
On track to submit filing for pre-filled syringe (PFS) in second quarter 2024

“The team at argenx has made significant progress executing across the ambitious plan we set out at the beginning of the year,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “We are driven by our commitment to provide patients with the broadest gMG product offering that consistently delivers on safety and efficacy. VYVGART SC played a key role in our growth over the quarter, expanding the breadth of our prescriber base and reaching new patients. The relationships we have built and key market learnings in gMG position us for success as we scale the organization and prepare for CIDP. After generating the data required for filing, we are also excited to advance the development of our pre-filled syringe, which should further enhance the patient experience.”

“The clinical opportunity ahead is expansive – we are preparing for registrational trials across multiple programs including empasiprubart in MMN and efgartigimod in Sjogren's disease, in addition to those already underway in TED and seronegative gMG. We look forward to deepening our understanding of FcRn with additional Phase 2 data points expected this year, while rapidly working to deliver on our promise of innovation by bringing the next wave of molecules to the clinic.”

FIRST QUARTER 2024 AND RECENT BUSINESS UPDATE

Reaching More Patients with VYVGART

VYVGART (efgartigimod alfa-fcab) is a first-in-class antibody fragment targeting the neonatal Fc receptor (FcRn), and is now the first FcRn antagonist approved in two indications. VYVGART is approved in more than 30 countries globally for the treatment of generalized myasthenia gravis (gMG) and is approved in Japan for the treatment of primary immune thrombocytopenia (ITP). VYVGART subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) is approved in the U.S. (as VYVGART® Hytrulo), Japan (as VYVDURA®) and Europe, making VYVGART the only gMG treatment available as both an IV and simple SC injection.

Generated global net product sales (inclusive of both VYVGART and VYVGART SC) of $398 million in the first quarter of 2024
VYVGART approved in Japan for treatment of ITP on March 26, 2024, marking first global approval for ITP
Additional VYVGART and VYVGART SC regulatory decisions on approval expected for gMG in 2024, including VYVGART in Switzerland, Australia, Saudi Arabia and South Korea, and VYVGART SC in China through Zai Lab
Multiple VYVGART SC regulatory submissions under review or planned for chronic inflammatory demyelinating polyneuropathy (CIDP), including:
FDA review of Supplemental Biologics License Application (sBLA) ongoing with Prescription Drug User Fee Act (PDUFA) target action date of June 21, 2024
Regulatory submissions completed in China and Japan
Regulatory submissions expected in Europe and Canada by end of 2024
Registrational study of VYVGART in seronegative gMG patients ongoing with aim to expand label into broader MG populations
FDA submission for VYVGART SC prefilled syringe for gMG and CIDP expected in second quarter of 2024, following positive data outcomes from bioequivalence and human factor studies
Advancing Current Pipeline

argenx continues to demonstrate breadth and depth within its immunology pipeline and is advancing multiple pipeline-in-a-product candidates. argenx is solidifying its leadership in FcRn biology and expects that efgartigimod will be approved or under evaluation in at least 15 indications by 2025. argenx is also advancing its earlier stage pipeline programs, including empasiprubart (C2 inhibitor) with Phase 2 studies ongoing in multifocal motor neuropathy (MMN), delayed graft function (DGF) and dermatomyositis (DM). In addition, argenx is evaluating ARGX-119, a muscle-specific kinase (MuSK) agonist in both congenital myasthenic syndrome (CMS) and amyotrophic lateral sclerosis (ALS).

Decision announced to advance development of efgartigimod in primary Sjogren’s disease (SjD) to Phase 3 following analysis of topline data from Phase 2 RHO study
Topline data from Phase 2 ALPHA study of efgartigimod in post-COVID-19 postural orthostatic tachycardia syndrome (PC-POTS) expected in second quarter of 2024
Topline data from seamless Phase 2/3 ALKIVIA study evaluating efgartigimod across three myositis subsets (immune-mediated necrotizing myopathy (IMNM)), anti-synthetase syndrome (ASyS), and DM expected in second half of 2024
Update on BALLAD study development plan evaluating efgartigimod in bullous pemphigoid (BP) expected by end of 2024
Registrational studies ongoing of efgartigimod in thyroid eye disease (TED)
Decision made to discontinue planned development of efgartigimod in ANCA-associated vasculitis (AAV) following risk assessment of all ongoing studies based on learnings from ADDRESS (pemphigus) and ADVANCE SC (ITP) studies
Proof-of-concept studies ongoing with efgartigimod in membranous nephropathy (MN) and lupus nephritis (LN) with studies expected to start this year in antibody mediated rejection (AMR) and newly nominated indication, systemic sclerosis (SSc)
Full Phase 2 topline data (cohorts 1 and 2) from ARDA study of empasiprubart in MMN expected in 2024; cohort 2 ongoing to determine dose response ahead of Phase 3 study start
Phase 1b/2a trials of ARGX-119 to assess early signal detection in patients with CMS and ALS expected to start in 2024
Leveraging Repeatable Innovation Playbook to Drive Long-Term Pipeline Growth

argenx continues to invest in its discovery engine, the Immunology Innovation Program (IIP), to drive long-term sustainable pipeline growth. Through the IIP, four new pipeline candidates have been nominated, including: ARGX-213 targeting FcRn and further solidifying argenx’s leadership in this new class of medicine; ARGX-121 and ARGX-220, which are first-in-class targets broadening argenx’s focus across the immune system; and ARGX-109, targeting IL-6, which plays an important role in inflammation. Investigational new drug (IND) applications for each program are expected to be filed by end of 2025.

Appointment of Brian L. Kotzin, MD as Non-executive Director to Board of Directors

Dr. Brian Kotzin has been appointed as non-executive director to the Board of Directors and Chair of the Research & Development Committee for a term of four years. He is currently a consultant for companies developing therapeutics for autoimmune and inflammatory diseases. His prior roles include Chief Medical Officer for Nektar Therapeutics and Vice President of Global Clinical Development, Head of the Inflammation Therapeutic Area and Vice President and Head of Medical Sciences at Amgen.

FIRST QUARTER 2024 FINANCIAL RESULTS

argenx SE

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS

see & read more on
https://www.argenx.com/news/argenx-reports-first-quarter-2024-financial-results-and-provides-business-update

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