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[{"orgOrder":0,"company":"Mereo BioPharma Group","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mereo BioPharma Announces Additional Positive Data from Phase 2b ASTEROID Study of Setrusumab in Adults with Osteogenesis Imperfecta and Provides Update on Regulatory Progress","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Mereo BioPharma Group","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mereo BioPharma Receives FDA Rare Pediatric Disease Designation for Setrusumab for the Treatment of Osteogenesis Imperfecta","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Mereo BioPharma Group","sponsor":"Ultragenyx Pharmaceutical","pharmaFlowCategory":"D","amount":"$304.0 million","upfrontCash":"$50.0 million","newsHeadline":"Ultragenyx and Mereo BioPharma Announce Collaboration and License Agreement for Setrusumab in Osteogenesis Imperfecta","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Ultragenyx Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ultragenyx Announces First Patient Dosed in Pivotal Phase 2\/3 Clinical Study of Setrusumab (UX143) for the Treatment of Osteogenesis Imperfecta","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Ultragenyx Pharmaceutical","sponsor":"J.P. Morgan","pharmaFlowCategory":"D","amount":"$345.0 million","upfrontCash":"Undisclosed","newsHeadline":"Ultragenyx Announces Proposed Public Offering of Common Stock","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Ultragenyx Pharmaceutical","sponsor":"J.P. Morgan","pharmaFlowCategory":"D","amount":"$300.0 million","upfrontCash":"Undisclosed","newsHeadline":"Ultragenyx Announces Pricing of Public Offering of Common Stock and Pre-Funded Warrants","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Ultragenyx Pharmaceutical","sponsor":"J.P. Morgan","pharmaFlowCategory":"D","amount":"$326.1 million","upfrontCash":"Undisclosed","newsHeadline":"Ultragenyx Announces Closing of Public Offering of Common Stock and Pre-Funded Warrants and Full Exercise of Underwriters' Option to Purchase Additional Shares","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Ultragenyx Pharmaceutical","sponsor":"Mereo BioPharma Group","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ultragenyx and Mereo BioPharma to Present Setrusumab Data Update at ASBMR","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Ultragenyx Pharmaceutical","sponsor":"Mereo BioPharma Group","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ultragenyx and Mereo BioPharma Announce Positive Data from the Ongoing Phase 2\/3 Orbit Study of Setrusumab (UX143) in Osteogenesis Imperfecta (OI)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Ultragenyx Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ultragenyx Announces First Patients Dosed in Phase 3 Program Evaluating Setrusumab (UX143) for the Treatment of Osteogenesis Imperfecta (OI)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Ultragenyx Pharmaceutical","sponsor":"Mereo BioPharma Group","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ultragenyx and Mereo BioPharma Announce Interim Phase 2 Data from Phase 2\/3 Orbit Study Demonstrating Setrusumab (UX143) Significantly Reduced Fracture Rates in Patients with Osteogenesis Imperfecta (OI)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Ultragenyx Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ultragenyx Announces Completion of Enrollment in Phase 3 Orbit and Cosmic Studies Evaluating Setrusumab (UX143) for the Treatment of Osteogenesis Imperfecta (OI)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2024","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals for Setrusumab
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Companies By Therapeutic Area
Details:
UX143 (setrusumab) is a fully human monoclonal antibody that inhibits sclerostin, a protein that acts on a key bone-signaling pathway that inhibits the maturation and activity of bone-forming cells in Osteogenesis Imperfecta.
Lead Product(s):
Setrusumab
Therapeutic Area: Genetic Disease Product Name: UX143
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableApril 30, 2024
Details:
The proceeds will advance company's late-stage clinical programs, including UX143 (setrusumab), an investigational, fully human mAb that inhibits sclerostin, support commercial launch, and advance its preclinical pipeline through IND applications into clinical development.
Lead Product(s):
Setrusumab
Therapeutic Area: Genetic Disease Product Name: UX143
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator:
J.P. Morgan
Deal Size: $326.1 millionUpfront Cash: Undisclosed
Deal Type: Public OfferingOctober 23, 2023
Details:
The proceeds will advance company's late-stage clinical programs, including UX143 (setrusumab), an investigational, fully human mAb that inhibits sclerostin, support commercial launch, and advance its preclinical pipeline through IND applications into clinical development.
Lead Product(s):
Setrusumab
Therapeutic Area: Genetic Disease Product Name: UX143
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator:
J.P. Morgan
Deal Size: $300.0 millionUpfront Cash: Undisclosed
Deal Type: Public OfferingOctober 18, 2023
Details:
The proceeds will advance company's late-stage clinical programs, including UX143 (setrusumab), an investigational, fully human mAb that inhibits sclerostin, support commercial launch, and advance its preclinical pipeline through IND applications into clinical development.
Lead Product(s):
Setrusumab
Therapeutic Area: Genetic Disease Product Name: UX143
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator:
J.P. Morgan
Deal Size: $345.0 millionUpfront Cash: Undisclosed
Deal Type: Public OfferingOctober 17, 2023
Details:
UX143 (setrusumab) is a fully human monoclonal antibody that inhibits sclerostin, a protein that acts on a key bone-signaling pathway that inhibits the maturation and activity of bone-forming cells in Osteogenesis Imperfecta.
Lead Product(s):
Setrusumab
Therapeutic Area: Genetic Disease Product Name: UX143
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator:
Mereo BioPharma Group
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableOctober 14, 2023
Details:
UX143 (setrusumab) is a fully human monoclonal antibody that inhibits sclerostin, a protein that acts on a key bone-signaling pathway that inhibits the maturation and activity of bone-forming cells in Osteogenesis Imperfecta.
Lead Product(s):
Setrusumab
Therapeutic Area: Genetic Disease Product Name: UX143
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableJuly 06, 2023
Details:
UX143 (setrusumab) is a fully human monoclonal antibody that inhibits sclerostin, a protein that acts on a key bone-signaling pathway that inhibits the maturation and activity of bone-forming cells in Osteogenesis Imperfecta.
Lead Product(s):
Setrusumab
Therapeutic Area: Genetic Disease Product Name: UX143
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator:
Mereo BioPharma Group
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableJune 05, 2023
Details:
Setrusumab (UX143) is a fully human monoclonal antibody that inhibits sclerostin, a protein that acts on a key bone-signaling pathway that inhibits the activity of bone-forming cells.
Lead Product(s):
Setrusumab
Therapeutic Area: Genetic Disease Product Name: UX143
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator:
Mereo BioPharma Group
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableSeptember 09, 2022
Details:
Orbit study builds on finding of 12-month Phase 2b ASTEROID study, which demonstrated that treatment with setrusumab resulted in clear, dose-dependent and statistically significant effect on bone formation and bone density at multiple anatomical sites among adult participant.
Lead Product(s):
Setrusumab
Therapeutic Area: Genetic Disease Product Name: UX143
Highest Development Status: Phase II/ Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableApril 20, 2022
Details:
Ultragenyx will lead future global development of setrusumab in both pediatric and adult patients. Mereo granted Ultragenyx an exclusive license to develop and commercialize setrusumab in the US and rest of the world, excluding Europe where Mereo retains commercial rights.
Lead Product(s):
Setrusumab
Therapeutic Area: Genetic Disease Product Name: BPS-804
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator:
Ultragenyx Pharmaceutical
Deal Size: $304.0 millionUpfront Cash: $50.0 million
Deal Type: CollaborationDecember 17, 2020
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