argenx Announces Positive Topline Results from ADAPT SERON Study of VYVGART in AChR-Ab Seronegative gMG Patients

argenx has announced positive topline results from the ADAPT SERON study of VYVGART in patients with AChR-Ab seronegative gMG. The study met its primary endpoint, demonstrating clinically meaningful improvements in disease activity across all three subtypes – MuSK+, LRP4+, and triple seronegative. VYVGART was well tolerated and safe, with no new safety concerns identified. argenx plans to submit a supplemental biologics license application to the FDA by end of 2025.

Amsterdam, the Netherlands – Argenx SE (Euronext & Nasdaq: ARGX), a global immunology company, announced positive topline results from its pivotal ADAPT SERON study of VYVGART® in patients with AchR-Ab seronegative generalized myasthenia gravis (gMG). The study achieved its primary endpoint, demonstrating statistically significant and clinically meaningful improvements in disease activity across all three subtypes – MuSK+, LRP4+, and triple seronegative. The drug maintained its established safety profile with no new concerns identified [1].

The ADAPT SERON study was a randomized, double-blind, placebo-controlled, multi-center trial evaluating the safety and efficacy of efgartigimod alfa-fcab (VYVGART) in adults with AchR-Ab seronegative gMG. The primary endpoint was the change in MG-ADL (Myasthenia Gravis Activities of Daily Living) total score from baseline to day 29. The study enrolled 119 participants across North America, Europe, China, and the Middle East [1].

Argenx plans to submit a Supplemental Biologics License Application (sBLA) to the FDA by the end of 2025 to expand VYVGART’s label to include adult AchR-Ab seronegative gMG patients across all three subtypes. This development positions Argenx to significantly expand its addressable market for gMG treatments [1].

The study's positive results validate Argenx's mechanistic approach targeting pathogenic IgGs as underlying drivers of gMG across all patient subtypes, potentially establishing VYVGART as a foundational therapy for the broader MG population. The drug was well-tolerated and safe across seronegative subtypes, with no new safety concerns identified [1].

References:
[1] https://www.stocktitan.net/news/ARGX/argenx-announces-positive-topline-results-from-adapt-seron-study-of-ogpvuzfr98mp.html