Announced details
Acute spinal cord injury
The counterparty to which the company submitted an IND application in preparation for beginning a Phase III clinical trial in the US. Capital and personnel relationships are Not disclosed.
US pharmaceutical regulatory authority. Other information on its location, representative, capital, and year of establishment is Not disclosed.
Orphan drug designation for acute spinal cord injury (Japan, US, Europe)
The company expects this to enhance business value in the future, but the specific impact on financial results is Not disclosed.
The company does not address Contract Value / Offering price.
National Spinal Cord Injury Statistical Center, Traumatic Spinal Cord Injury Facts and Figures at a Glance, 2026
| Item | Details |
|---|---|
| Names of Products / Services Covered | oremepermin alfa (オレメペルミン アルファ, recombinant human HGF protein) |
| Counterparty | U.S. Food and Drug Administration (FDA) |
| Counterparty overview | US pharmaceutical regulatory authority. Other information on its location, representative, capital, and year of establishment is Not disclosed. |
| Relationship with the Company | The counterparty to which the company submitted an IND application in preparation for beginning a Phase III clinical trial in the US. Capital and personnel relationships are Not disclosed. |
| Launch date | Timing of the start of the Phase III clinical trial in the US is Not disclosed (IND application submitted) |
| Applicable area | Acute spinal cord injury |
| Award/certification name | Orphan drug designation for acute spinal cord injury (Japan, US, Europe) |
| Impact on Business Performance | The company expects this to enhance business value in the future, but the specific impact on financial results is Not disclosed. |
| Source | National Spinal Cord Injury Statistical Center, Traumatic Spinal Cord Injury Facts and Figures at a Glance, 2026 |
Items this document does not state (9)
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.The objective is to advance development with a view to obtaining approval in the US, based on the results of nonclinical studies to date and clinical development in Japan, in preparation for beginning a Phase III clinical trial in the US. The company explains that this will also help expand opportunities for strategic partnerships with pharmaceutical companies and for securing research and development funding, as well as enhance business value.