Drugs.com New Drug ApplicationsOriginal article
Ultragenyx Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application (BLA) for DTX401 AAV Gene Therapy for Glycogen Storage Disease Type Ia (GSDIa)
BLA FilingDTX401Positive
AI Analysis
Summary
Ultragenyx announced FDA acceptance of the BLA for DTX401, an AAV gene therapy for Glycogen Storage Disease Type Ia, with priority review designation.
Outcome Details
BLA accepted for review with priority review designation
Importance:7/10
Sentiment:
0.70
AAV gene therapyBLA acceptancepriority reviewrare diseaseGSDIa
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Published by Drugs.com New Drug Applications on February 23, 2026 4:02 AM