FDA accepts Ultragenyx DTX401 BLA for priority review in GSDIa with Aug. 23, 2026 PDUFA date

Reuters02-23
FDA accepts Ultragenyx DTX401 BLA for priority review in GSDIa with Aug. 23, 2026 PDUFA date

Ultragenyx Pharmaceutical Inc. said the U.S. Food and Drug Administration has accepted for review its Biologics License Application for DTX401 (pariglasgene brecaparvovec), an AAV gene therapy for Glycogen Storage Disease Type Ia. The FDA granted Priority Review and set a PDUFA action date of Aug. 23, 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Ultragenyx Pharmaceutical Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9658946-en) on February 23, 2026, and is solely responsible for the information contained therein.

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