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argenx Eyes Up to Five Potential U.S. Launches for 2027

The slate includes disease-specific applications, a planned auto-injector and a possible empasiprubart launch tied to December trial results.

Updated 2 min read
The office tower housing argenx’s U.S. headquarters rises above a downtown Boston street. (AI-generated image / EconoTimes)
The office tower housing argenx’s U.S. headquarters rises above a downtown Boston street. (AI-generated image / EconoTimes)

On Thursday, Oct. 22, CEO Karen Massey said argenx is considering as many as five U.S. launches for 2027, potentially covering new uses for existing medicines, an auto-injector and a drug still in clinical development.

The quarter closed Sept. 30, 2026, with product sales of $1.721 billion, up 54% from the year-earlier period and 13% from the second quarter. For 2026, argenx expects about $4 billion in research and development (R&D) and selling, general and administrative (SG&A) costs, including expenses tied to Forte Biosciences. The sales figure covers one quarter, while the cost outlook is for the full year.

The company’s quarterly results listed R&D spending of $503 million and SG&A spending of $598 million. Quarterly operating expenses came to $1.266 billion in total; that figure covers a different period and set of costs from the full-year R&D and SG&A forecast.

The FDA placed applications for pediatric generalized myasthenia gravis (gMG) on priority review, setting a target action date in February 2027. The company has filed for an ocular myasthenia gravis indication. By the end of 2026, argenx expects a separate submission seeking a VYVGART Hytrulo indication for immune-mediated necrotizing myopathy (IMNM). Those steps are not at the same point: pediatric gMG is being reviewed, the ocular use has been filed, and the IMNM application remains planned.

argenx also plans a second-half 2027 release of a VYVGART Hytrulo auto-injector for indications already approved. The original VYVGART is authorized for gMG; VYVGART Hytrulo carries authorization for both gMG and chronic inflammatory demyelinating polyneuropathy (CIDP).

argenx expects December 2026 results from its Phase 3 empasiprubart trial in multifocal motor neuropathy (MMN). Massey said a favorable result would lead argenx to ask the FDA for priority review. The FDA’s target action date for pediatric gMG applications is in February 2027.

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