Argenx’s Vyvgart Shows Positive Phase 3 Results in Seronegative Myasthenia Gravis

Argenx announced positive topline results from the ADAPT SERON Phase 3 trial of Vyvgart (efgartigimod) in patients with AChR-Ab seronegative generalized myasthenia gravis (gMG)15.

The study met its primary endpoint with statistically significant (p=0.0068) and clinically meaningful improvements in MG-ADL (Myasthenia Gravis Activities of Daily Living) scores compared to placebo125.

This is the first global Phase 3 trial to demonstrate efficacy across all three seronegative subtypes:
MuSK+, LRP4+, and triple seronegative myasthenia gravis15.

Vyvgart maintained its established safety profile, with no new safety concerns reported in the trial1.

Argenx plans to submit a Supplemental Biologics License Application (sBLA) to the FDA for an expanded Vyvgart label covering AChR-Ab seronegative gMG subtypes by the end of 202515.

Sources:

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

2. https://firstwordpharma.com/story/5991725

5. https://trial.medpath.com/news/fecf4e83780066ae/vyvgart-achieves-primary-endpoint-in-phase-3-trial-for-achr-ab-seronegative-myasthenia-gravis