other_material
confidence high
sentiment positive
materiality 0.70
Mereo BioPharma and Ultragenyx Provide Update on Phase 3 Orbit and Cosmic Studies of UX143 in Osteogenesis Imperfecta
Mereo BioPharma Group plc
- The Phase 3 Orbit study final analysis is expected around end of 2025, with a threshold of p<0.04.
- DMC informed Ultragenyx that UX143 has an acceptable safety profile and study should continue to final analysis.
- Safety in the younger patient population (Cosmic study) is consistent with other studies; no interim analysis of Cosmic data.
- Final analyses will occur after patients have been on therapy for at least 18 months; threshold for Cosmic is p<0.05.
item 8.01