Efgartigimod PDUFA date: FDA decision expected January 3, 2027
The FDA is expected to decide on Efgartigimod from argenx SE in generalized myasthenia gravis 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.
Source: sec.gov · Data checked November 7, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
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Questions about this FDA decision
- When is the PDUFA date for Efgartigimod?
- The FDA's PDUFA target action date for Efgartigimod is January 3, 2027. The FDA can act before that date, and the review can be extended.
- What is Efgartigimod being reviewed for?
- The application under FDA review covers generalized myasthenia gravis.
- Which company is developing Efgartigimod?
- argenx SE (ARGX).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).