Announced details
Adenovirus infections after hematopoietic stem cell transplantation
Working relationship involving discussions and confirmation of application requirements and submission materials for a CMA application in the UK
An agency under the UK Department of Health and Social Care responsible for the regulation and safety of medicines and medical devices
MHRA headquarters, London
No impact on the consolidated earnings outlook for the fiscal year ending December 2026
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | Brincidofovir injection (IV BCV) |
| Counterparty | Medicines and Healthcare products Regulatory Agency (MHRA) |
| Counterparty overview | An agency under the UK Department of Health and Social Care responsible for the regulation and safety of medicines and medical devices |
| Relationship with the Company | Working relationship involving discussions and confirmation of application requirements and submission materials for a CMA application in the UK |
| Applicable area | Adenovirus infections after hematopoietic stem cell transplantation |
| Location | MHRA headquarters, London |
| Impact on Business Performance | No impact on the consolidated earnings outlook for the fiscal year ending December 2026 |
Items this document does not state (11)
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 discuss and confirm the details of the data package required for a CMA application in the UK, and clarify the scope and requirements for the materials to be submitted for the application.