FDA Delays Approval For Ultragenyx's Gene Therapy, But Not A Dealbreaker, Says Analyst

benzinga.com/news/fda/25/07/46399211/fda-delays-approval-for-ultragenyxs-gene-therapy-but-not-a-dealbreaker-says-analyst

The U.S. Food and Drug Administration issued on Friday a Complete Response Letter for Ultragenyx Pharmaceutical Inc.’s (NASDAQ:RARE) Biologics License Application (BLA) for UX111 (ABO-102) AAV gene therapy for Sanfilippo syndrome type A (MPS IIIA).
In the CRL, the FDA requested that the…

This story appeared on benzinga.com, 2025-07-14 17:05:53.
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