Ultragenyx Pharmaceutical Inc. announced results from the Phase 3 Orbit and Cosmic studies evaluating setrusumab (UX143) in patients with Osteogenesis Imperfecta $(OI)$. Both studies did not achieve their primary endpoints of reducing annualized clinical fracture rates compared to placebo (Orbit) or bisphosphonates (Cosmic). However, both studies met their secondary endpoints, showing statistically significant improvements in bone mineral density. No changes were observed in the safety profile of setrusumab. The company stated it will implement significant expense reductions following these results and continues to build commercial revenue from its approved products. The results from these studies have already been presented.
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