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Upcoming FDA decision · February 24, 2027

RARE PDUFA date: FDA decision expected February 24, 2027

The FDA is expected to decide on this application from Ultragenyx Pharmaceutical Inc. by the PDUFA target action date of February 24, 2027. NDA filing. Extracted from SEC filing: 8-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.

February 24
Target action date
NDA
Stage
Detected
Date confidence
FDA designations