TMS Co., Ltd.
PMDA-facing advisory for the domestic first-half Phase II trial of TMS-008 has ended
The in-person advisory with PMDA regarding the domestic first-half Phase II trial of TMS-008 has ended. Preparations such as site selection and submission of the clinical trial notification will proceed as a start of the trial. The cost impact is within the already disclosed R&D cost range, and there is no impact on the results for the fiscal year ending December 2026.
Key Figures
- Specific procedures for trial initiation: site selection, submission of the clinical trial notification (timing unknown)
- R&D cost range: Unknown
- Impact on results: No impact in FY2026
AI要約
News overview
Today, Timms announces that the in-person advisory with the PMDA for TMS-008's domestic first-half Phase II trial has ended. Going forward, concrete preparations toward trial initiation, such as site selection and filing the clinical trial notification, will proceed. The related current-period costs are included in the previously disclosed R&D cost range, and there is no impact on the FY2026 results.
Clinical development progress and outlook
TMS-008 targets acute kidney injury after cardiac surgery and is part of a low-molecule compound family with anti-inflammatory action via sEH inhibition. Preparations for the Phase II trial are underway, and following the end of the in-person advisory, specific procedures for trial initiation will proceed. This is expected to advance the development of a new therapeutic to address unmet medical needs.
Timms Co., Ltd.
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