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Upcoming FDA decision · January 3, 2027

Efgartigimod PDUFA date: FDA decision expected January 3, 2027

102 days to goargenx SE (ARGX) →

The FDA is expected to decide on Efgartigimod from argenx SE in Postural Orthostatic Tachycardia Syndrome by the PDUFA target action date of January 3, 2027. For generalized myasthenia gravis. BLA filing. Extracted from SEC filing: 6-K

A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.

January 3
Target action date
Phase 3
Stage
Detected
Date confidence
FDA designations