RoslinCT, a global contract development and manufacturing organization (CDMO) specializing in advanced cell therapies, and ...

Ultragenyx Pharmaceutical said on Monday that late-stage studies showed its drug for a type of genetic bone disease failed to ...

Setrusumab is a monoclonal antibody that inhibits sclerostin, a protein that negatively regulates bone development, allowing for new bone formation.

Ultragenyx is developing setrusumab in pediatric and young adult patients across OI sub-types I, III and IV with two late-stage studies: the pivotal Phase 2/3 Orbit study and Phase 3 Cosmic study.

Shares in Ultragenyx and Mereo BioPharma have plunged after their drug for osteogenesis imperfecta (OI) or brittle bone ...

Neither study achieved its primary endpoint of reduction in annualized clinical fracture rate compared to placebo (ORBIT) or bisphosphonates ...

Ultragenyx Pharma announces phase 3 Orbit & Cosmic results for setrusumab in osteogenesis imperfecta: Novato, California Wednesday, December 31, 2025, 18:00 Hrs [IST] Ultragenyx P ...

And in a phase III trial win, Foresee Pharmaceuticals said its long-acting gonadotropin-releasing hormone agonist leuprolide ...

Ultragenyx and Mereo BioPharma shares fall as phase III Orbit and Cosmic studies of setrusumab in osteogenesis imperfecta miss primary endpoints.

Neither study achieved its primary endpoint of reduction in annualized clinical fracture rate compared to placebo (Orbit) or bisphosphonates (Cosmic) Both studies achieved the secondary endpoint of im ...

Neither study achieved its primary endpoint of reduction in annualized clinical fracture rate compared to placebo (ORBIT) or bisphosphonates (COSMIC) Both studies achieved secondary endpoint of improv ...

Ultragenyx Pharmaceutical and Mereo BioPharma Group saw their shares plummet after ringing out 2025 by announcing the failures of their brittle bone disease candidate setrusumab (UX143) in a pair of ...