Ultragenyx Completes Rolling BLA Submission to FDA for DTX401 Gene Therapy
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Ultragenyx Pharmaceutical Inc. has completed the rolling submission of its Biologics License Application (BLA) to the FDA for DTX401 gene therapy, aimed at treating Glycogen Storage Disease Type Ia. The submission is backed by clinical data from 52 patients, demonstrating significant improvements in treatment outcomes. The FDA had previously granted a rolling review, allowing for ongoing submission of BLA modules, which has now been finalized with the last module submission.
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