Ultragenyx Pharmaceutical (RARE) has received Breakthrough Therapy Designation from the FDA for setrusumab as a treatment to reduce the risk of fracture associated with osteogenesis imperfecta Type I, III, or IV in patients 2 years of age and older. The decision was based on preliminary clinical evidence including the positive 14-month results from the Phase 2 portion of the Orbit study.
Setrusumab was granted Orphan Drug Designation in the United States and EU, rare pediatric disease designation in the United States, and accepted into the European Medicine Agency's Priority Medicines program.
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Business News
May 15, 2026 15:25 ET Apart from the confirmation of Kevin Warsh as the next Fed chair, the main news on the economics front this week included key price data from the U.S. and the first quarter economic growth figures from major economies. Both consumer prices and producer costs have started to reflect the effect of supply shocks due to the Middle East conflict. In Europe, GDP data was in focus, while inflation data from China dominated the news flow in Asia.