The FDA has accepted BridgeBio Pharma's New Drug Application for oral infigratinib to treat children with achondroplasia and granted it Priority Review status. The agency assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 4, 2027. If approved, the drug would be the first and only approved oral therapy for this condition. BridgeBio plans to submit a Marketing Authorization Application to the European Medicines Agency in the fourth quarter of 2026. The company operates as a commercial-stage biopharmaceutical firm focused on developing medicines for genetic conditions.
