[{"orgOrder":0,"company":"Histogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Histogen Reports FDA Clinical Hold for Planned Phase 1\/2 Trial of HST-003 for Knee Cartilage Regeneration","therapeuticArea":"Orthopedics\/Orthopedic Surgery","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Histogen"},{"orgOrder":0,"company":"Quince Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Quince Therapeutics Presents Preclinical Data at MHSRS 2022 Demonstrating Preclinical Efficacy of Bone-Targeting Platform for Traumatic Bone Injury","therapeuticArea":"Orthopedics\/Orthopedic Surgery","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Peptide","graph2":"Quince Therapeutics"}]
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In preclinical studies, Quince observed a decrease in fracture healing time by 50% in NOV004 treated groups. Additionally, bone deposition and max load doubled and the force required to refracture the bones increased more than two-fold in mouse models.
U.S. FDA has verbally notified the company that it has additional questions about the company’s IND application package for the planned Phase 1/2 clinical trial of HST-003.