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 opportunities12345.

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 documentation1.

The restructuring aims to keep the company on track for profitability in 2027, with R&D expenses expected to drop 38% in 20271.

Upcoming catalysts include potential FDA approval of DTX401 in Q3 2026 and phase 3 readout for Angelman syndrome therapy in H2 20261.

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-tracker-2026

3. https://www.nasdaq.com/articles/ultragenyx-pharma-loss-narrows-cut-10-workforce

4. https://www.investing.com/news/earnings/ultragenyx-shares-fall-as-2026-revenue-guidance-misses-expectations-93CH-4504127

5. https://www.biospace.com/press-releases/ultragenyx-reports-fourth-quarter-and-full-year-2025-financial-results-and-corporate-update