VYVGART’s Milestone Approval: A Game-Changer for CIDP Patients and Investors

The recent positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for VYVGART® (efgartigimod alfa) in chronic inflammatory demyelinating polyneuropathy (CIDP) marks a pivotal moment for both Halozyme Therapeutics (NASDAQ: HALO) and its partner argenx SE (NASDAQ: ARGX). This subcutaneous (SC) formulation, developed using Halozyme’s proprietary ENHANZE® drug delivery technology, positions the drug as the first novel mechanism of action for CIDP in over three decades. For investors, the approval underscores a compelling opportunity in autoimmune therapies, driven by unmet medical needs, robust financial synergies, and a strategic pipeline expansion.

A Breakthrough for CIDP Patients

CIDP, a rare autoimmune disease affecting approximately 31,413 patients in the EU, has long relied on treatments like intravenous immunoglobulin (IVIg), which are logistically cumbersome and costly. VYVGART’s SC formulation, administered in just 20–30 seconds, offers a transformative alternative. Backed by the ADHERE clinical trial, the drug demonstrated a 61% reduction in relapse risk compared to placebo, alongside improvements in mobility and strength. The CHMP’s approval—expected to secure final EU marketing authorization by mid-2025—expands VYVGART’s reach into a critical market, addressing a significant unmet need.

Financial Synergies: Growth for Halozyme and argenx

The collaboration between Halozyme and argenx is a masterclass in technology licensing and shared commercial upside. Halozyme’s ENHANZE platform, which facilitates rapid SC delivery of biologics, has been licensed to over 20 pharmaceutical partners, including giants like Roche and Takeda. For VYVGART, the partnership’s financial terms hinge on royalty revenue, with Halozyme benefiting directly from argenx’s sales.

Key data points:
- Halozyme’s 2025 royalty revenue is projected to grow by 30%–35% to $725–$750 million, driven by VYVGART’s strong adoption in CIDP and generalized myasthenia gravis (gMG).
- argenx’s 2024 global net sales of VYVGART reached $2.2 billion, with Q4 sales hitting $737 million—a 45% year-over-year increase.

The CHMP approval accelerates this trajectory. By expanding VYVGART’s label in Europe, argenx can now capture a market where IVIg remains the standard but is associated with high costs and logistical challenges. With the pre-filled syringe (PFS) formulation gaining FDA approval in April 2025, VYVGART’s convenience and efficacy could rapidly displace older therapies.

Strategic and Clinical Momentum

Beyond CIDP, the collaboration’s success is reinforced by pipeline synergies:
1. argenx’s Vision 2030: The company aims to secure 10 labeled indications and treat 50,000 patients globally. CIDP’s EU approval is a critical step toward these goals, with ongoing trials in MMN, myositis, and thyroid eye disease.
2. Halozyme’s ENHANZE Platform: The technology’s versatility is evident in its use across nine commercialized products, including Roche’s Phesgo and Janssen’s Darzalex SC. Future applications in argenx’s next-generation therapies, such as empasiprubart (a C5 complement inhibitor), could further drive royalty growth.

Risks and Considerations

• Market Competition: IVIg therapies remain entrenched, and reimbursement negotiations in Europe could delay widespread adoption.
• Operational Costs: argenx’s 2025 R&D and SG&A expenses are projected at $2.5 billion, though sales growth should offset these costs and achieve sustainable profitability by year-end.
• Regulatory Hurdles: While the EU approval timeline is clear, delays in other regions (e.g., Japan or Canada) could affect timelines.

Conclusion: A Win-Win for Investors

The CHMP’s approval of VYVGART for CIDP is a strategic and financial win for both Halozyme and argenx. For Halozyme, the partnership’s royalty-driven model ensures scalable, high-margin revenue growth, with ENHANZE’s broader applications providing a long tail of opportunities. For argenx, the CIDP indication expands its addressable market and solidifies its position as a leader in autoimmune therapies.

The numbers tell the story:
- Halozyme’s adjusted EBITDA is expected to rise to $755–$805 million in 2025, a 24%–32% increase over 2024.
- argenx’s 2025 sales could surpass $3 billion if CIDP and gMG approvals drive adoption in major markets.

Investors should note that both companies are well-funded—argenx ended 2024 with $3.4 billion in cash—and are executing on clear, data-backed strategies. While risks exist, the combination of first-in-class innovation, strong financials, and a robust pipeline makes this collaboration a high-conviction opportunity in the autoimmune space.

In short, VYVGART’s EU CIDP approval isn’t just a regulatory milestone—it’s a catalyst for sustained growth, making Halozyme and argenx compelling buys for investors focused on transformative therapies.