Announced details
Adenovirus infections after hematopoietic stem cell transplantation
The number of registered clinical trial participants was 30 as of 17 September 2026 (target: 69 by the end of 2026 and 180 by the end of 2027)
The organisation with which discussions have begun toward obtaining conditional early marketing authorisation (CMA) for BCV in the UK.
An agency under the UK's Department of Health and Social Care, responsible for the authorisation and safety of medicines and medical devices.
Conditional early marketing authorisation (CMA)
Medicines and Healthcare products Regulatory Agency (MHRA)
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 (BCV) |
| Counterparty | Medicines and Healthcare products Regulatory Agency (MHRA) |
| Counterparty overview | An agency under the UK's Department of Health and Social Care, responsible for the authorisation and safety of medicines and medical devices. |
| Relationship with the Company | The organisation with which discussions have begun toward obtaining conditional early marketing authorisation (CMA) for BCV in the UK. |
| Applicable area | Adenovirus infections after hematopoietic stem cell transplantation |
| Award/certification name | Conditional early marketing authorisation (CMA) |
| Awarding / certifying body | Medicines and Healthcare products Regulatory Agency (MHRA) |
| Usage history | The number of registered clinical trial participants was 30 as of 17 September 2026 (target: 69 by the end of 2026 and 180 by the end of 2027) |
| Impact on Business Performance | No impact on the consolidated earnings outlook for the fiscal year ending December 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.Adenovirus infections after hematopoietic stem cell transplantation are serious and treatment options are extremely limited. Some patients do not achieve an adequate response to existing antiviral therapies, while continued administration can be difficult from a safety perspective. The company says the discussions reflect requests from clinical physicians and constructive dialogue with the regulatory authority.