AGIO

Agios Pharmaceuticals, Inc.

FDA PDUFA Target Action Date

Sunday, December 7, 2025

170 days ago

pending

Drug Information

Drug Name: AQVESME (mitapivat) (CT.gov)
Application Type: sNDA
Indication: Alpha- or beta-thalassemia (anemia)

Filing Details

Company: Agios Pharmaceuticals, Inc. →
Stock Ticker: AGIO
SEC CIK: 0001439222
Source: Company IR →

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: 2026-03-22. Report an issue