Ultragenyx gets FDA Breakthrough Therapy Designation for setrusumab in osteogenesis imperfecta

Ultragenyx Pharmaceutical Inc.

Received FDA Breakthrough Therapy Designation for setrusumab (UX143) for OI Type I, III, IV in patients ≥2 years.
Designation based on Phase 2 data from Orbit (14-month) and Asteroid studies showing significant fracture rate reduction.
Breakthrough Therapy aims to expedite development and review for serious diseases with preliminary clinical evidence.
Ultragenyx collaborates with Mereo BioPharma on UX143 development.
Designation does not guarantee approval but may speed regulatory process.

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