Komori
Other Disclosures4582SymBio Pharmaceuticals LimitedPharmaceuticals

Brincidofovir (BCV), agreement reached with the UK's MHRA on the marketing authorisation application

SymBio Pharmaceuticals agreed with the UK's MHRA to proceed with the marketing authorisation application for BCV for adenovirus infections after hematopoietic stem cell transplantation, primarily using data from the existing Phase 2 trial and compassionate use program. Preparations are under way for submission during January 2027.

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Announced details

Brincidofovir (BCV, SyB V-1901 injection)
Applicable field (uses covered by this announcement)

Adenovirus infections after hematopoietic stem cell transplantation (UK)

What the company reported numerically
Usage history

45 patients enrolled in a global Phase 3 clinical trial as of the end of October 2026

Relationship between the counterparty and the company
SymBio Pharmaceuticals Limited4582
Relationship with the Company

The relationship between the regulatory authority and the applicant concerning BCV's marketing authorisation application in the UK.

CounterpartyMedicines and Healthcare products Regulatory Agency (MHRA)

An agency under the UK's Department of Health and Social Care. It is the executive agency responsible for the authorisation and safety of medicines and medical devices.

Impact on Business Performance

No impact on the consolidated earnings outlook for the fiscal year ending December 2026

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

ID Week 2024 (Infectious Diseases Society of America Week), press release dated 23 October 2024

Announced details
ItemDetails
Names of Products / Services CoveredBrincidofovir (BCV, SyB V-1901 injection)
CounterpartyMedicines and Healthcare products Regulatory Agency (MHRA)
Counterparty overviewAn agency under the UK's Department of Health and Social Care. It is the executive agency responsible for the authorisation and safety of medicines and medical devices.
Relationship with the CompanyThe relationship between the regulatory authority and the applicant concerning BCV's marketing authorisation application in the UK.
Applicable areaAdenovirus infections after hematopoietic stem cell transplantation (UK)
Usage history45 patients enrolled in a global Phase 3 clinical trial as of the end of October 2026
Impact on Business PerformanceNo impact on the consolidated earnings outlook for the fiscal year ending December 2026
SourceID Week 2024 (Infectious Diseases Society of America Week), press release dated 23 October 2024
Items this document does not state (10)
Contract ValueOffering priceContract DateLaunch dateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationLocation scaleQuantitative Effects

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.

Because recognition grew that BCV could become an important treatment option in a disease area involving severe conditions with extremely limited treatment options.

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