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Ultragenyx Announces Layoff of 130 Employees Amid FDA Delays on UX111 Resubmission

Ultragenyx is laying off about 130 employees, representing 10% of its workforce, as part of a strategic restructuring plan to reduce expenses and focus on high-impact opportunities 1 2 3 4 5 . The layoffs follow failed phase 3 trials of setrusumab for osteogenesis imperfecta (brittle bone disease) 1 . Ultragenyx resubmitted its BLA for gene therapy UX111 for Sanfilippo syndrome type A last month after an FDA complete response letter in July 2025 over manufacturing issues; the FDA recently requested additional documentation 1 . The restructuring aims to keep the company on track for profitability in 2027, with R&D expenses expected to drop 38% in 2027 1 . Upcoming catalysts include potential FDA approval of DTX401 in Q3 2026 and phase 3 readout for Angelman syndrome therapy in H2 2026 1 . Sources: 1. https://www.fiercebiotech.com/biotech/ultragenyx-lays-10-workforce-wake-phase-3-brittle-bone-trial-fails 2. https://www.fiercebiotech.com/biotech/fierce-biotech-layoff-tra...

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