Ultragenyx disclosed a strategic restructuring that includes laying off roughly 10% of staff after a year of disappointing late‑stage trial results. The company reported that two brittle bone disease trials of setrusumab missed primary endpoints, prompting a reevaluation of programs and a push to reduce operating expenses. Separately, Ultragenyx’s biologics manufacturing files are under heightened FDA scrutiny: the agency requested additional supportive documentation for the company’s gene therapy application for Sanfilippo syndrome type A, delaying potential regulatory action. The firm resubmitted its application after prior manufacturing-related pushbacks and now faces further review requirements. Ultragenyx framed the moves as necessary to focus resources on high‑value programs and to position the company for profitability goals in the coming years while handling regulatory follow‑up on UX111.