Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
The FDA approved DTX401 (pariglasgene brecaparvovec) on Aug 19, 2026. It is an Ultragenyx Pharmaceutical Inc. program in glycogen Storage Disease Type Ia (GSDIa). 1 FDA decision on record below. Every date links its source.
FDA approval tracked on pdufa.bio: glycogen Storage Disease Type Ia (GSDIa) (approved Aug 19, 2026). Earlier approvals may not be listed here; the FDA label is the full record. 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.
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
When is DTX401 (pariglasgene brecaparvovec)'s next FDA decision or readout?
No upcoming catalyst is on our calendar for DTX401 (pariglasgene brecaparvovec); 1 FDA decision is on record below.
What happened at DTX401 (pariglasgene brecaparvovec)'s most recent FDA decision?
On Aug 19, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
What is DTX401 (pariglasgene brecaparvovec) used for?
In our records DTX401 (pariglasgene brecaparvovec) is FDA-approved for glycogen Storage Disease Type Ia (GSDIa) (approved Aug 19, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Who makes DTX401 (pariglasgene brecaparvovec)?
Ultragenyx Pharmaceutical Inc. (RARE).
Has DTX401 (pariglasgene brecaparvovec) been approved by the FDA?
Yes. The FDA approved an application for DTX401 (pariglasgene brecaparvovec) on Aug 19, 2026; the decision page linked above carries the source.
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.
Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.