BridgeBio Pharma Receives FDA Acceptance For Filing Its New Drug Application With Priority Review For Oral Infigratinib To Treat Achondroplasia

BridgeBio Pharma, Inc. (Nasdaq: BBIO) announced that the FDA has accepted its New Drug Application for oral infigratinib, aimed at treating children with achondroplasia, with Priority Review status. The FDA has set a target action date of February 4, 2027, for the Prescription Drug User Fee Act (PDUFA). BridgeBio is prepared to launch the drug upon approval.