AMT-191 PDUFA date: FDA decision expected May 1, 2027
The FDA is expected to decide on AMT-191 from uniQure N.V. in Fabry Disease by the PDUFA target action date of May 1, 2027. For Huntington's Disease EX-99. BLA filing. Extracted from: uniQure Announces FDA Acceptance and Priority Review of the Biologics License Application for ifezuntirgene inilparvovec for the Treatment of Huntington's Disease
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 6, 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 AMT-191?
- The FDA's PDUFA target action date for AMT-191 is May 1, 2027. The FDA can act before that date, and the review can be extended.
- What is AMT-191 being reviewed for?
- The application under FDA review covers Fabry Disease.
- Which company is developing AMT-191?
- uniQure N.V. (QURE).
- 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).