FDA accepts BridgeBio NDA for oral infigratinib with priority review for achondroplasia

BridgeBio Pharma announced FDA acceptance and Priority Review of its New Drug Application for oral infigratinib for children with achondroplasia, with a PDUFA target date of February 4, 2027. The Phase 3 PROPEL 3 trial met its primary endpoint of annualized height velocity and showed statistically significant improvements in body proportionality and arm span. The company is prepared for a US launch upon approval and plans an EMA submission in Q4 2026.