With Vyvgart established, argenx looks beyond its founder CEO

Van Hauwermeiren will succeed Peter Verhaeghe, who is retiring from the Board after nearly two decades of service since 2008, a period that saw argenx evolve from a research-focused biotech into a global commercial-stage company. These leadership changes are designed to ensure stability while positioning argenx for its next phase of expansion in rare autoimmune diseases.

A leadership transition timed with argenx’s next growth phase

This transition comes as argenx advances its “Vision 2030” strategy, which aims to deliver breakthrough science to 50,000 patients worldwide. The roadmap prioritizes sustained investment in Vyvgart (efgartigimod) and a growing portfolio of antibody-based therapeutics, while expanding leadership in myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.

Tim Van Hauwermeiren said in the company’s press release that “Karen [Massey] has delivered exceptional impact since joining argenx three years ago – accelerating Vyvgart’s launch, building a future-proof commercial engine, being a leading ambassador of our culture, and connecting to and inspiring our teams,” adding that as Chairman, he “will be a sounding board to Karen [Massey] and the team on long-term strategy” with the goal to “lead the Board’s evolution” to facilitate argenx’ next phase of growth.

How Vyvgart became argenx’s central commercial asset

Vyvgart is a first-in-class FcRn antagonist that has rapidly become one of the most important recent launches in rare autoimmune diseases. Initially approved for generalized myasthenia gravis (gMG), Vyvgart has demonstrated strong uptake across major markets, driven by its differentiated mechanism of action, favorable efficacy profile, and both intravenous (labelled Vyvgart) and subcutaneous (labelled Vyvgart Hytrulo) formulations. The therapy works by reducing pathogenic IgG1 antibodies, addressing the underlying drivers of disease rather than just symptoms.

Although it recently stopped a Phase 3 trial for thyroid eye disease associated with the autoimmune thyroid conditions Graves’ disease or Hashimoto’s thyroiditis after an interim analysis, argenx is actively expanding Vyvgart’s label into additional indications, including chronic inflammatory demyelinating polyneuropathy (CIDP), immune thrombocytopenia (ITP), and other antibody-mediated disorders.

Competition tightens as the FcRn field fills up

Competition in the FcRn space for gMG is crowded. UCB’s Rystiggo (rozanolixizumab), Johnson & Johnson’s Imaavy (nipocalimab), and AstraZeneca’s Soliris (eculizumab) and Ultomiris (ravulizumab) are among the most prominent challengers. With a different approach, Amgen’s Uplizna (inebilizumab), a monoclonal antibody targeting CD19-positive B cells, was approved by the FDA for gMG patients in December.

Other companies are also investing in innovative therapies: Cartesian Therapeutics is currently enrolling a Phase 3 trial to test a CAR-T therapy for gMG, Descartes-08; and Regeneron is awaiting FDA discussions for its siRNA investigational therapy, cemdisiran, which showed positive results in a Phase 3 trial for gMG in August last year. Despite this crowded landscape, Vyvgart currently benefits from first-mover advantage, strong physician familiarity, and expanding real-world evidence.

Beyond Vyvgart, argenx continues to invest in its earlier-stage pipeline, including novel antibody-based therapies targeting severe autoimmune conditions with high unmet need.

As argenx enters this next chapter, the leadership transition signals a shift from founder-led execution to a more mature governance model. With Vyvgart gaining momentum and competition heating up, the coming years will be critical in determining whether argenx can fully realize its “Vision 2030” ambitions to establish the biotech as a leading global rare disease immunology company with multiple blockbuster franchises.