Acacia Pharma Group plc announces the initiation of its Food and Drug Administration (FDA)-mandated pivotal study investigating Byfavo® (remimazolam injection) in the moderate sedation of pediatric patients (the “Study”). The study will enroll approximately 100 children aged up to and including 17 years at leading institutions across the United States and Denmark. The Study is expected to take 9-12 months to complete. If successful and upon approval by FDA of a supplemental New Drug Application for Byfavo, it is expected that the US label of Byfavo will be expanded to include moderate sedation for procedures in pediatric patients.