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Efgartigimod or Efgartigimod PH20

Phase 2

Generalized Myasthenia Gravis | Monoclonal antibody | Neurology |argenx SE|Last Updated: Apr 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05374590Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia GravisPHASE2 ENROLLING BY_INVITATION 12Aug 18, 2022Sep 1, 2029Apr 23, 202616 United States, Belgium +8
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Study Endpoints
Primary Endpoints
Incidence of AEs, SAEs and AESIs
Up to 4 years

AE : adverse event; SAE : serious adverse event; AESI : adverse event of special interest

Secondary Endpoints
Incidence of ADAs against efgartigimod
Up to 4 years
Incidence of antibodies against rHuPH20
Up to 4 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Efgartigimod or Efgartigimod PH20 SCEXPERIMENTALPatients receiving Efgartigimod IV treatment or Efgartigimod PH 20 SC treatment
Interventions
NameTypeDescription
Efgartigimod IV or Efgartigimod PH20 SCBIOLOGICALIntravenous infusion of Efgartigimod or Subcutaneous injection of Efgartigimod PH20 SC
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Eligibility Criteria
Age Range2 Years — 18 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * The participant completed ARGX-113-2006, defined as: 1. The participant reached End of Trial in trial ARGX-113-2006 or End of Study in ARGX-113-2207 and agreed to participate in the ARGX-113-2008 trial. 2. The participant qualifies for retreatment in trial ARGX-113-2006, ...

Countries:United StatesBelgiumCanadaFranceGermanyIsraelNetherlandsPolandSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05374590primaryCompletionDate: changed
LOWMay 24, 2026NCT05374590studyFirstPostDate: changed