Sunday, November 1, 2026
13 days ago
pending Drug Information
- Drug Name
- mitapivat (CT.gov)
- Application Type
- Priority Review
Filing Details
- Company
- AGIOS PHARMACEUTICALS, INC. →
- Stock Ticker
- AGIO
- SEC CIK
- 0001439222
- Source
- SEC filing →
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
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Data sourced from SEC EDGAR filings. Last updated: 2026-11-05. Report an issue