Ultragenyx Resubmits BLA for UX111 Gene Therapy to FDA with PDUFA Date Expected in Q3

Reuters02-03 21:00
Ultragenyx Resubmits BLA for UX111 Gene Therapy to FDA with PDUFA Date Expected in Q3

Ultragenyx Pharmaceutical Inc. has announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for UX111 (rebisufligene etisparvovec), an investigational gene therapy for Sanfilippo syndrome Type A (MPS IIIA). The company expects the FDA to review the application under an accelerated approval pathway, with a Prescription Drug User Fee Act (PDUFA) date anticipated in the third quarter of 2026. The review period is expected to last up to six months, in accordance with FDA guidelines.

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: GNW9647519-en) on February 03, 2026, and is solely responsible for the information contained therein.

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