ARGX

VYVGART (efgartigimod alfa-fcab)

Name: ARGENX SE FDA PDUFA Decision
Start: 2026-05-10

FDA PDUFA Target Action Date · ARGENX SE

Sunday, May 10, 2026

Approved

approved

Note: Approved 2026-05-08 as VYVGART HYTRULO (SUPPL BLA761304). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-07-30; 2d from the PDUFA date.

Drug Information

Drug Name: VYVGART (efgartigimod alfa-fcab) (CT.gov)
Application Type: sBLA
Indication: acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis (gMG)
Approved As: VYVGART (efgartigimod alfa-fcab)

Filing Details

Company: ARGENX SE
Stock Ticker: ARGX
SEC CIK: 0001697862
Source: SEC EDGAR (LLM-extracted from primary filing via full-text search) →

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.

Standard Review: 10 months from filing acceptance
Priority Review: 6 months from filing acceptance
Possible Outcomes: Approval, Complete Response Letter (CRL), or extension

Track All FDA Decisions

View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.

View FDA Calendar →

Data sourced from SEC EDGAR filings. Last updated: 2026-05-10. Report an issue