(RTTNews) - Argenx SE (ARGX) has taken a significant step toward broadening the reach of VYVGART, after the U.S. FDA accepted the company's supplemental Biologics License Application for Priority Review.
The filing seeks approval for the use of VYVGART in adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis, a population that has long faced limited treatment options and has historically been excluded from clinical trials.
AChR-Ab seronegative gMG refers to patients who do not test positive for acetylcholine receptor antibodies and often face greater diagnostic challenges and fewer approved treatment options.
The supplemental application is supported by data from the Phase 3 ADAPT SERON study, which demonstrated statistically significant and clinically meaningful improvements in MG-ADL scores across all seronegative subgroups, including MuSK-positive, LRP4-positive, and triple-seronegative patients.
Safety findings remained consistent with the established profile of VYVGART, with no new concerns identified.
The FDA has set a PDUFA action date of May 10, 2026.
If approved for the proposed indication, VYVGART would become the first targeted treatment option for AchR-Ab seronegative gMG, marking a meaningful advance for patients who currently lack approved therapies.
VYVGART, which contains the active ingredient Efgartigimod, is already approved across major global markets for AChR- positive generalized myasthenia gravis, including the United States, European Union, China, Canada and Japan. It also holds approvals in chronic inflammatory demyelinating polyneuropathy (CIDP) worldwide and in primary immune thrombocytopenia (ITP) in Japan.
The drug continues to be a major commercial engine for argenx.
The company also markets VYVGART SC, a subcutaneous combination of efgartigimod alfa and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology to facilitate subcutaneous injection delivery of biologics. It is marketed as VYVGART Hytrulo in the U.S., VYVGART SC in Europe, VYVDURA in Japan, and may be marketed under different proprietary names following approval in other regions.
The company's preliminary full-year 2025 global product net sales totaled $4.15 billion, up 90% year-over-year, including $1.29 billion in fourth-quarter sales.
ARGX has traded between $510.05 and $934.62 over the past year. The stock closed yesterday's trading at $796.00, up 0.95%.
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