The face-to-face consultation with PMDA regarding TMS-008’s domestic early Phase II clinical trial has been completed, and the Company will proceed with preparations for starting the trial, including site selection and submission of the clinical trial notification.
Acute kidney injury after cardiovascular surgery (postoperative AKI), etc.
In connection with receiving face-to-face consultation from PMDA for the implementation of TMS-008’s domestic early Phase II clinical trial.
An independent administrative agency responsible for approval reviews and safety measures for pharmaceuticals, medical devices and other products. The disclosure does not provide details of its address, representative, capital or year of establishment.
There will be no impact on results for the fiscal year ending December 2026. The costs related to this matter are included in the range of research and development expenses for the current fiscal year announced on 13 February 2026.
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | TMS-008 |
| Counterparty | Pharmaceuticals and Medical Devices Agency (PMDA) |
| Counterparty overview | An independent administrative agency responsible for approval reviews and safety measures for pharmaceuticals, medical devices and other products. The disclosure does not provide details of its address, representative, capital or year of establishment. |
| Relationship with the Company | In connection with receiving face-to-face consultation from PMDA for the implementation of TMS-008’s domestic early Phase II clinical trial. |
| Applicable area | Acute kidney injury after cardiovascular surgery (postoperative AKI), etc. |
| Impact on Business Performance | There will be no impact on results for the fiscal year ending December 2026. The costs related to this matter are included in the range of research and development expenses for the current fiscal year announced on 13 February 2026. |
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
Because the face-to-face consultation with PMDA regarding the implementation of the early Phase II clinical trial has been completed.