argenx (NASDAQ:ARGX) used its presentation at the 44th JPMorgan Healthcare Conference to highlight what CEO Tim Van Hauwermeiren described as the company’s patient-focused approach, its commercial momentum for VYVGART, and a broad pipeline strategy aimed at expanding both near-term indications and longer-term innovation.
Patient impact and “Vision 2030” goals
Van Hauwermeiren opened with a question he said every biotech entrepreneur should ask: “Who would miss you if you wouldn’t exist?” He tied the answer to patients treated with VYVGART, featuring remarks from a patient, Sam, who said that before VYVGART Hytrulo he had trouble walking to the end of his driveway and now walks 10 miles a day and scuba dives. Van Hauwermeiren said such transformations reflect breakthrough science and are central to the company’s “Vision 2030.”
Commercial update: VYVGART momentum and profitability
Van Hauwermeiren said the company delivered a “strong Q4 in 2025,” reporting about $1.3 billion in sales, up 14% from the prior quarter, and said the business “almost doubled” in 2025 compared to 2024. He also said 2025 was the first year argenx reached “structural profitability.”
In a panel discussion, argenx executive Karen described continued double-digit quarter-on-quarter growth in VYVGART 16 quarters after launch. She pointed to “consistent momentum, consistent patient growth,” and said she views VYVGART as still in the early part of its growth journey across myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP), with additional potential from new readouts in rheumatology.
Strategy for expanding VYVGART across indications
Van Hauwermeiren described argenx’s commercial and clinical “playbook” as redefining biology, treatment paradigms, and patient outcomes. In MG, he said argenx has established what he called a new “gold standard” of “minimum symptom expression” (MSE) and cited a real-world rate of 60% of VYVGART patients achieving MSE. He also said the prefilled syringe (PFS) has been a growth driver and highlighted market access as a “secret power,” stating the company’s goal of not leaving any patient behind.
He said VYVGART is the most prescribed biologic in MG and is driving 60% of biologic growth in that market, with 70% of patients coming “straight from orals.” In CIDP, he said VYVGART reached blockbuster status in Q3 of last year and that the U.S. prescriber base has grown to more than 4,700 active prescribers, a 20% year-over-year increase.
Key near-term clinical and regulatory milestones discussed included:
- Seronegative MG: Van Hauwermeiren said argenx submitted an sBLA for seronegative MG and expects a potential approval in the second half of the year.
- Ocular MG: He said data are expected in the first quarter and cited a post-hoc analysis of ADAPT showing VYVGART’s impact on the eye muscle domain comparable to other muscle domains. Karen said ocular MG is an important driver of an expanded MG addressable market.
- Real-world evidence in MG: Van Hauwermeiren referenced steroid-sparing data and reductions in hospitalizations and length of stay.
In CIDP, Van Hauwermeiren said argenx sees a growth path beyond a “refractory” population, noting entry into patients currently treated with steroids and/or IVIG and referencing translational work suggesting both IgG- and potential IgM-mediated subsets.
FcRn franchise and next-generation development
As a second strategic priority, Van Hauwermeiren said argenx intends to “shape the long-term future of FcRn.” He highlighted the company’s current product options—an IV product and two subcutaneous presentations (one administered by healthcare professionals and one self-administered)—and pointed to its exclusive partnership with Halozyme as enabling a “unique formulation.” He also said an autoinjector is “well on its way” for a 2027 launch, and noted the company has begun combination studies in MG, which he said are listed publicly on ClinicalTrials.gov.
He said argenx plans to advance ARGX-213, described as a next-generation FcRn candidate, and noted ARGX-124 is in phase I. He also argued that combination therapy, common in oncology, will become a standard in autoimmunity.
Pipeline updates: EMPA, ARGX-121, and new assets
Van Hauwermeiren discussed a broader “next wave of innovation,” including empasiprubart (EMPA), which he said is being developed in more than three indications. He presented phase II ARDA trial data in multifocal motor neuropathy (MMN), including open-label extension data shown for the first time, describing improvements in function and grip strength after switching from placebo to EMPA and continued improvement over time on treatment. Karen said a change in the MMN primary endpoint was requested by the FDA and aligned with the phase II endpoint, with data expected in Q4 2026.
He also discussed ARGX-213 pharmacodynamic data from a healthy volunteer study, describing the goal of matching weekly efgartigimod dosing effects with a single monthly subcutaneous push. In addition, he presented phase I data for ARGX-121, which he described as an “IgA sweeper,” saying a single subcutaneous dose completely and selectively eliminated IgA with a clean safety profile, and that the candidate is ready to move into IgA-driven diseases.
argenx also highlighted a deal with Tensegrity, which Van Hauwermeiren described as the first of what he expects to be multiple partnerships with biotech companies. He said the agreement adds three molecules to the pipeline: ARGX-118 (targeting Galectin-10), ARGX-125 (a bispecific antibody against undisclosed targets), and TSP-101 (targeting Fn14 in muscle regeneration).
Looking ahead, Van Hauwermeiren summarized expected phase III readouts, including ocular MG data in the first quarter, myositis in the third quarter, and ITP in the fourth quarter. He said Sjögren’s data are expected in the second half of 2027, and that EMPA readouts are expected in the fourth quarter of 2026, with initial CIDP data in the second half of 2027. He and Karen also said R&D investment is expected to rise as the company advances its expanding pipeline.
About argenex (NASDAQ:ARGX)
argenx (NASDAQ: ARGX) is a biotechnology company focused on the discovery, development and commercialization of antibody-based therapeutics for severe autoimmune and neuromuscular diseases. The company uses its proprietary SIMPLE Antibody platform to generate differentiated antibodies and engineered Fc regions, and it pursues mechanisms that modulate the neonatal Fc receptor (FcRn) to reduce pathogenic IgG levels. Argenx’s research and development activities span target identification, preclinical development and late-stage clinical programs aimed at addressing unmet needs in immunology.
The company’s lead product, efgartigimod (marketed as Vyvgart), is an FcRn antagonist developed to reduce circulating IgG antibodies and treat IgG-mediated disorders.
