Argenx (ARGX) Gains FDA Priority Review for Expanded Vyvgart Use

 Argenx (ARGX) has secured priority review from the U.S. FDA for its application to expand the use of Vyvgart, a treatment for generalized myasthenia gravis (gMG). The supplemental Biologics License Application seeks approval for adults with acetylcholine receptor antibody-negative gMG. The FDA has set a target decision date of May 10, 2026. This application is backed by successful Phase 3 ADAPT SERON study results. Vyvgart, already approved for antibody-positive gMG, achieved $2.2 billion in global sales in 2024.

https://www.gurufocus.com/news/4107927/argenx-argx-gains-fda-priority-review-for-expanded-vyvgart-use