argenx SE
VYVGART
generalized myasthenia gravis (gMG)
Resolved
58days ago
FDA decision · May 10, 2026
What's at stake
The FDA's approval decision on VYVGART for generalized myasthenia gravis (gMG) is due May 10, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 6-K
verified 11h ago
“Results will be used to support a planned supplemental Biologics License Application (sBLA) submission to the U.S. Food and Drug Administration (FDA) to expand the label into oMG.”