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Pegunigalsidase alfa

Phase 3

Fabry Disease | Monoclonal antibody | Metabolic |Protalix BioTherapeutics, Inc. (DE)|Last Updated: Sep 12, 2023

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
UNCONTROLLED
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03180840Safety, Efficacy, & PK of PRX-102 in Patients With Fabry Disease Administered Intravenously Every 4 WeeksPHASE3 COMPLETED 30Jul 1, 2017Jul 1, 2020Sep 12, 2023 -
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Study Design & Arms
Interventions
NameTypeDescription
Pegunigalsidase alfaBIOLOGICALPegunigalsidase alfa 2 mg/kg every 4 weeks
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