Worth reading
63In focus
0–100. This measures how worthwhile something is to read, not how good or bad the company is.Direction
Neutral
Direction inferred from the company’s description.Scale
—
Displayed only when the document provides numerical figures.Wording
Conditional
How definitive the wording is.Decision and Details
Application for manufacturing and marketing approval of the regenerative medicine product “Stemchymal®”
Decision24 June 2026 (application date)
Implementation24 June 2026 (record of application)
Going forwardPriority review is targeted for completion within 9 months of acceptance of the application. The Company will proceed toward obtaining approval and plans to market and ship the product after approval.
Reason
Effective treatments for spinocerebellar ataxia are limited, and there is a strong need for new treatment options.
Impact on Business Performance
The impact on results for the current fiscal year is expected to be limited at this time. Over the medium to long term, the Company believes this will make a significant contribution to further growth and the sustained enhancement of corporate value.
| Item | Details |
|---|---|
| Matter Covered | Application for manufacturing and marketing approval of the regenerative medicine product “Stemchymal®” |
| Decision Date | 24 June 2026 (application date) |
| Implementation Date | 24 June 2026 (record of application) |
| Impact on Business Performance | The impact on results for the current fiscal year is expected to be limited at this time. Over the medium to long term, the Company believes this will make a significant contribution to further growth and the sustained enhancement of corporate value. |
| Reason | Effective treatments for spinocerebellar ataxia are limited, and there is a strong need for new treatment options. |
| Governing Rule | The product has been designated as a regenerative medicine product for a rare disease and is eligible for priority review. |
| Related previous disclosures | Designation by the Ministry of Health, Labour and Welfare as a regenerative medicine product for a rare disease in December 2018 (title not disclosed) |
| Future plans | Priority review is targeted for completion within 9 months of acceptance of the application. The Company will proceed toward obtaining approval and plans to market and ship the product after approval. |
Items this document does not state (4)
Decision-Making BodyPeriod CoveredAmountQuantity / scale
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.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Effective treatments for spinocerebellar ataxia are limited, and there is a strong need for new treatment options.
How to read this page
This is not the documentKomori reads the disclosure the company filed and writes this summary. Figures are as stated by the company and are not audited.
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Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.