Argenx says Phase 3 myasthenia gravis study met primary endpoint

Argenx (ARGX) announced the presentation of new data further highlighting the efficacy and safety of Vyvgart across generalized myasthenia gravis patient populations. The Phase 3 ADAPT SERON study met its primary endpoint, demonstrating that AChR-Ab seronegative myasthenia gravis patients treated with Vyvgart achieved a statistically significant improvement in Myasthenia Gravis Activities of Daily Living total score compared to placebo after four weeks, the company said in a statement. In the overall population, mean change from baseline in patients treated with Vyvgart was a clinically meaningful 3.35 point improvement in MG-ADL total score at week 4, the company added. “These positive results in MG-ADL score mean patients experienced significant improvements in one or a combination of their abilities in breathing, eating, eyesight and motor functions,” according to Argenx. The company plans to share these results with the FDA and seek expansion of the Vyvgart label.