Announced details
Drug development and regulatory decision-making for acute spinal cord injury
As of July 2026, SCI PFDD includes 10 patient organizations and 5 companies, including pharmaceutical and biotechnology companies
The Company has joined SCI PFDD. As of July 2026, SCI PFDD includes 10 patient organizations and 5 companies, including pharmaceutical and biotechnology companies.
SCI PFDD is a patient-focused drug development initiative based on the framework of the FDA’s Patient-Focused Drug Development (PFDD) program. NASCIC is a North American nonprofit consortium that promotes collaboration among patients, healthcare professionals, researchers, companies and others. SCOPE is an international consortium that promotes improvements in clinical trial design and outcome measures for spinal cord injury. Christopher & Dana Reeve Foundation is a US nonprofit organization that provides funding for research into spinal cord injury treatments and related activities.
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
U.S. Food and Drug Administration (FDA)
| Item | Details |
|---|---|
| Names of Products / Services Covered | Recombinant human HGF protein (International Nonproprietary Name (INN): oremepermin alfa), SCI Patient-Focused Drug Development（SCI PFDD） |
| Counterparty | SCI PFDD, North American Spinal Cord Injury Consortium (NASCIC), SCOPE（Spinal Cord Outcomes Partnership Endeavor）, Christopher & Dana Reeve Foundation |
| Counterparty overview | SCI PFDD is a patient-focused drug development initiative based on the framework of the FDA’s Patient-Focused Drug Development (PFDD) program. NASCIC is a North American nonprofit consortium that promotes collaboration among patients, healthcare professionals, researchers, companies and others. SCOPE is an international consortium that promotes improvements in clinical trial design and outcome measures for spinal cord injury. Christopher & Dana Reeve Foundation is a US nonprofit organization that provides funding for research into spinal cord injury treatments and related activities. |
| Relationship with the Company | The Company has joined SCI PFDD. As of July 2026, SCI PFDD includes 10 patient organizations and 5 companies, including pharmaceutical and biotechnology companies. |
| Launch date | 29 September 2026 (planned; PFDD meeting with the FDA) |
| Applicable area | Drug development and regulatory decision-making for acute spinal cord injury |
| Usage history | As of July 2026, SCI PFDD includes 10 patient organizations and 5 companies, including pharmaceutical and biotechnology companies |
| Source | U.S. Food and Drug Administration (FDA) |
Items this document does not state (10)
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.To contribute to the development of treatments that address patient needs, advance drug development in the spinal cord injury field, and improve patients’ quality of life.