argenx SE, ARGX, ARGX.BR, FDA Calendar, PDUFA Date

Company Name	argenx SE ARGX, ARGX.BR
Drug Name	VYVGART (sBLA)
Event Name	FDA decision on VYVGART with generalized myasthenia gravis who test negative for AChR antibodies (seronegative).
Event Date	05/10/2026
Outcome Date	05/08/2026
Outcome	FDA approved label expansion for VYVGART and VYVGART Hytrulo to include all serotypes of adult patients living with generalized myasthenia gravis on May 8, 2026
Drug Status	Priority review
Rival Drugs
Market Potential
Other Approvals	Vyvgart is already approved for the treatment of generalized myasthenia gravis (gMG) in adults who test positive for the anti-acetylcholine receptor (AChR) antibody.
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