29 September 2020 - Application accepted under priority review designation with breakthrough therapy designation and rare paediatric disease designation previously granted.
BridgeBio Pharma and affiliate Origin Biosciences today announced the US FDA has accepted its new drug application for fosdenopterin (previously BBP-870/ORGN001), a cyclic pyranopterin monophosphate substrate replacement therapy, for the treatment of patients with molybdenum cofactor deficiency type A.
This is BridgeBio’s first new drug application acceptance.