Argenx Se's Vyvgart to Capture 50% CIDP Market Share, Analyst Says Buy.

Argenx Se's Vyvgart is expected to drive growth in CIDP and gMG treatment, with a favorable safety profile and efficacy comparable to existing treatments. Vyvgart is anticipated to capture a 50% market share in CIDP and become the biologic of choice for gMG treatment. The approval of a pre-filled syringe is expected to further boost adoption, supporting a Buy rating with a price objective of $804.

June 19, 2025

Argenx SE's Vyvgart, a subcutaneous injection of efgartigimod alfa, has received European Commission approval for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults following corticosteroid or immunoglobulin therapy. This approval marks a significant advancement in CIDP treatment options, offering a new targeted therapy for patients [1].

The approval is based on positive results from the phase 3 ADHERE trial, which demonstrated a 61% reduction in relapse risk compared to placebo. Safety findings were consistent with previous studies, indicating a favorable safety profile [1].

Vyvgart is a human IgG1 antibody Fc-fragment that blocks the neonatal Fc receptor, reducing pathogenic IgG autoantibodies. The approval applies to all EU Member States, Iceland, Liechtenstein, and Norway, marking a substantial step forward in CIDP treatment [1].

Jean-Philippe Plançon, PhD, MSc, president of the European Patient Organisation for Dysimmune and Inflammatory Neuropathies (EPODIN), expressed hope and enthusiasm for the introduction of this new targeted therapy [1].

Argenx SE expects Vyvgart to drive growth in both CIDP and generalized myasthenia gravis (gMG) treatment, with a favorable safety profile and efficacy comparable to existing treatments. The company anticipates capturing a 50% market share in CIDP and becoming the biologic of choice for gMG treatment. The approval of a pre-filled syringe is expected to further boost adoption, supporting a Buy rating with a price objective of $804 [2].

The approval of Vyvgart SC positions Argenx SE as a leader in the CIDP treatment market, addressing a significant unmet medical need. The European market offers a substantial opportunity for market penetration, with the success of Vyvgart SC potentially paving the way for further approvals in other regions [2].

Continuous monitoring of patient outcomes and market feedback will be crucial in maintaining competitive advantage. Despite the approval, 85% of CIDP patients still require ongoing treatment, and 88% experience residual impairment. The long-term effects and broader applicability of Vyvgart SC in diverse patient populations remain to be fully understood [2].

References:
[1] argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy. News Release. Argenx. Published June 20, 2025. Accessed June 23, 2025. https://argenx.com/news/2024/argenx-announces-european-commission-approval-of-vyvgart--efgart
[2] argenx SE (ARGX, Financial) Gains European Approval for Vyvgart SC in CIDP Treatment. News Release. GuruFocus. Published June 20, 2025. Accessed June 23, 2025. https://www.gurufocus.com/news/2937467/argenx-se-argx-gains-european-approval-for-vyvgart-sc-in-cidp-treatment-argx-stock-news