Argenx’s Vyvgart: A Rare Disease Powerhouse Poised for Blockbuster Status

Argenx

Argenx SE (NASDAQ: ARGX) continues to expand its leadership in rare disease therapies, with its flagship drug, Vyvgart Hytrulo, gaining regulatory momentum. Earlier this year, the U.S. Food and Drug Administration approved Vyvgart Hytrulo for chronic inflammatory demyelinating polyneuropathy (CIDP), adding to its existing indications in the U.S. for generalized myasthenia gravis (gMG) and in Japan for primary immune thrombocytopenia (ITP). Recently, China’s regulator followed suit, making Vyvgart Hytrulo the first approved therapy for CIDP in the country, underscoring its global reach.

CIDP, a rare autoimmune disorder affecting the peripheral nervous system, leads to symptoms such as fatigue, muscle weakness, and sensory loss in the limbs. Until now, treatment options included steroids, immunoglobulin therapies, and plasma exchange—methods often burdened with side effects or logistical challenges. Vyvgart Hytrulo offers a targeted alternative, bolstering its appeal among patients and clinicians alike.

Consensus estimates from Visible Alpha project Vyvgart Hytrulo to generate $91 million in revenue in 2024, accelerating to $502 million by 2025. By 2027, the drug is anticipated to achieve blockbuster status with global sales of $1.5 billion, peaking at $3.7 billion by 2034.

Argenx faces competition in the CIDP space from several therapies advancing through clinical trials. Johnson & Johnson’s (NYSE: JNJ) Nipocalimab and Sanofi’s (NASDAQ: SNY) SAR445088 lead the pack in Phase III studies, while UCB’s (EBR: UCB) Rystiggo and Immunovant’s (NASDAQ: IMVT) and Roivant Sciences’ (NASDAQ: ROIV) IMVT-1401 are progressing through Phase II trials. Dianthus Therapeutics’ (NASDAQ: DNTH) DNTH103, currently in Phase I, further illustrates the sector’s competitive dynamics. However, Vyvgart, being the first drug approved for CIDP in the U.S., gives the drug a significant first-mover advantage.

*In the chart, we highlight Argenx’s Vyvgart revenues by indication along with the projected CIDP revenues for Argenx, Immunovant, and Dianthus Therapeutics — companies with available CIDP data.