AGIO PDUFA date: FDA decision expected November 1, 2026

The FDA is expected to decide on this application from Agios Pharmaceuticals, Inc. by the PDUFA target action date of November 1, 2026. Agios Pharmaceuticals outlines 2026 revenue expectations of $45M-$50M for its PK deficiency treatment ahead of a November 1 PDUFA decision for a sickle cell indication.

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.