NOVATO, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that all patients have been enrolled across the Phase 3 Orbit and Cosmic studies...
Phase 2/3 Orbit Study and Phase 3 Cosmic Study of setrusumab in Osteogenesis Imperfecta expected to complete enrollment around the end of first quarter and in the first half of 2024, respectively ...
Ultragenyx to share data from late-stage program evaluating setrusumab (UX143) in osteogenesis imperfecta at American Society for Bone and Mineral Research
Pivotal Phase 3 portion of Orbit study now enrolling approximately 195 pediatric and young adult patients Newly initiated Phase 3 Cosmic study now enrolling approximately 65 younger pediatric...
Pediatric data show substantial induction of bone production in 1 week and a large increase in bone formation within 3 months of initiating monthly setrusumab treatment Phase 3 sites beginning to...
NOVATO, Calif. and MOUNTAIN VIEW, Calif. and LONDON, Sept. 09, 2022 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), (“Ultragenyx”), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases and Mereo BioPharma Group plc (NASDAQ: MREO), (“Mereo”), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced that additional data from Mereo’s Phase 2b ASTEROID study related to setrusumab (UX143) and information on the Phase 2/3 Orbit study will be presented at the American Society for Bone and Mineral Research 2022 Annual Meeting (ASBMR) being held September 9-12, 2022, in Austin, Texas. Setrusumab is a monoclonal antibody in development for the treatment of Osteogenesis Imperfecta (OI), a rare disease affecting approximately 60,000 individuals in the US and Europe.
NOVATO, Calif., April 20, 2022 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for...
NOVATO, Calif., LONDON, and REDWOOD CITY, Calif., Dec. 17, 2020 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare diseases, and Mereo BioPharma Group plc (Nasdaq: MREO, AIM: MPH), a clinical stage biopharmaceutical company focused on oncology and rare diseases, today announced a license and collaboration agreement for setrusumab, a monoclonal antibody in clinical development for osteogenesis imperfecta (OI). Setrusumab is an investigational anti-sclerostin fully human monoclonal antibody that has shown the ability to improve bone production and density leading to greater bone strength in animal models of OI. Data from a Phase2b of setrusumab conducted by Mereo demonstrated a dose-dependent increase in bone formation, density, and strength in adults with OI.
NOVATO, Calif., LONDON, and REDWOOD CITY, Calif., Dec. 17, 2020 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (Nasdaq: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare diseases, and Mereo BioPharma Group plc (Nasdaq: MREO, AIM: MPH), a clinical stage biopharmaceutical company focused on oncology and rare diseases, today announced a license and collaboration agreement for setrusumab, a monoclonal antibody in clinical development for osteogenesis imperfecta (OI). Setrusumab is an investigational anti-sclerostin fully human monoclonal antibody that has shown the ability to improve bone production and density leading to greater bone strength in animal models of OI. Data from a Phase2b of setrusumab conducted by Mereo demonstrated a dose-dependent increase in bone formation, density, and strength in adults with OI.
LONDON and REDWOOD CITY, Calif., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH), “Mereo” or “the Company”, a clinical-stage biopharmaceutical company focused on oncology and rare diseases, today announces that the U.S. Food and Drug Administration (“FDA”) has granted Rare Pediatric Disease designation to setrusumab for the treatment of osteogenesis imperfecta (“OI”). Setrusumab is a fully humanized monoclonal antibody that inhibits sclerostin, a protein which inhibits the activity of bone-forming cells. OI is a genetic rare disorder with no approved treatments that is characterized by reduced bone mass and fragile bones that break easily. In Mereo’s Phase 2b ASTEROID study, setrusumab demonstrated a dose-dependent bone building effect and a trend of reduction in fractures in addition to being safe and well tolerated in adults with OI.