Path to a UK MAA for Brincidofovir

SymBio is advancing its efforts to obtain marketing authorization in the UK for its investigational injectable brincidofovir (hereinafter “IV BCV”) for the treatment of adenovirus infections following hematopoietic stem cell transplantation. To this end, the company has held an in-person meeting with the UK Medicines and Healthcare products Regulatory Agency (hereinafter “MHRA”). This page provides the latest updates on these efforts.

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Related news releases

2026.11.05

brincidofovir (BCV) reaches agreement with UK MHRA for approval application.

2026.10.23

Regarding the holding of an in-person meeting with the UK MHRA to obtain conditional early marketing authorization (CMA) for brincidofovir in the UK.

2026.10.20

Case reports showing remarkable efficacy with brincidofovir (BCV) presented at the British Society of Blood, Bone Marrow Transplantation and Cell Therapy (BSBMTCT) conference in Manchester.

2026.10.14

Regarding brincidofovir (BCV), the Briefing Book for the face-to-face consultation concerning conditional early marketing authorization (CMA) has been received in the UK.

2026.10.08

We have begun applying the Humanitarian Assistance Program (CUP) to brincidofovir.

2026.11.05

SymBio Reaches Agreement with UK MHRA on Marketing Authorisation Application for Brincidofovir (BCV)

2026.10.23

SymBio Completes In-Person Scientific Advice Meeting with the UK MHRA Regarding Conditional Marketing Authorisation (CMA) for Brincidofovir (BCV)

2026.10.20

Case Report Presentation Demonstrating Significant Efficacy of BCV -British Society of Blood and Marrow Transplantation and Cellular Therapy (BSBMTCT) in Manchester-

2026.10.14

UK MHRA Accepts Briefing Book for Face-to-Face Scientific Advice Meeting on Conditional Marketing Authorisation for Brincidofovir (BCV)

2026.10.08

SymBio Announces Initiation of Compassionate Use Program for Brincidofovir