Establishing an Overseas Clinical Development Framework for SHED-Based Cerebral Palsy Treatment
First written in FY2025-H1. 5 of 6 entries say "Advanced", first in FY2025. Latest entry: FY2026.
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- FY2026AdvancedAnnual report
「The Company's group reached a basic agreement with Treehill Partners, LLC to jointly establish a new company in the United States, with the primary aim of accelerating the clinical development of allogeneic SQ-SHED, mainly in the United States, and announced this in February 2026.」
Overseas clinical development of SHED treatment for cerebral palsy progressed to a basic agreement with Treehill to establish a new company in the United States. Preparations for an IND submission are also under way based on the agreements and advice obtained at the Pre-IND Meeting with the FDA. - FY2026-H1AdvancedAnnual report
「For overseas clinical trials, the Company held a Pre-IND Meeting with the US FDA (Food and Drug Administration) in October 2025.」
Overseas clinical development of SHED treatment for cerebral palsy progressed from establishing an overseas development structure to holding a pre-IND consultation with the US FDA. - FY2025AdvancedAnnual report
「The Company has concluded agreements with overseas contract research organizations and others and is working to establish a development structure, including the selection of principal investigators and clinical trial sites. As part of these efforts, in preparation for overseas clinical trials, a major overseas CRO evaluated the sufficiency of the Company's group's nonclinical study data, the drug product manufacturing process under development and the planned future studies, confirming that the necessary data acquisition and processes are progressing smoothly.」
Overseas clinical development of SHED treatment for cerebral palsy progressed to agreements with overseas contract research organizations, the selection of trial investigators and sites, and evaluation of data and the manufacturing process by a major overseas CRO. - FY2025-H1First statedAnnual report
「In preparation for clinical development in overseas markets targeting cerebral palsy in the remote phase, the Company is concluding agreements with overseas contract research organizations and others and working to establish a development structure, including the selection of principal investigators and clinical trial sites.」
For SHED treatment of cerebral palsy, the Company began establishing an overseas clinical development structure, including agreements with overseas contract research organizations and others and the selection of principal investigators and clinical trial sites.