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DTX401 (pariglasgene brecaparvovec)

Updated ยทnext FDA decision on the calendar

DTX401 (pariglasgene brecaparvovec) is a Ultragenyx Pharmaceutical Inc. program in Glycogen Storage Disease Type Ia (GSDIa). Every date links its source.

RARE catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: Glycogen Storage Disease Type Ia (GSDIa). Sponsor: Ultragenyx Pharmaceutical Inc. (RARE). Market-cap tier at the time we tracked it: Mid. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Aug 23, 2026RARE

Questions

When is DTX401 (pariglasgene brecaparvovec)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for DTX401 (pariglasgene brecaparvovec); no FDA decisions are on record below.

What happened at DTX401 (pariglasgene brecaparvovec)'s most recent FDA decision?

No FDA decision for DTX401 (pariglasgene brecaparvovec) is in our archive yet.

What is DTX401 (pariglasgene brecaparvovec) used for?

In our records DTX401 (pariglasgene brecaparvovec) is under review or in development for Glycogen Storage Disease Type Ia (GSDIa).

Who makes DTX401 (pariglasgene brecaparvovec)?

Ultragenyx Pharmaceutical Inc. (RARE).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.