BridgeBio's oral infigratinib NDA accepted by FDA with Priority Review; PDUFA date Feb 4, 2027

BridgeBio Pharma, Inc.

• FDA accepted for filing the NDA for oral infigratinib in children with achondroplasia under Priority Review, with a PDUFA target action date of February 4, 2027.
• PROPEL 3 Phase 3 met primary endpoint of annualized height velocity at Week 52: LS mean treatment difference +1.74 cm/yr, mean difference +2.10 cm/yr, p<0.0001; height Z-score also significant.
• First therapy to show statistically significant body-proportionality improvement in a randomized achondroplasia trial (mean difference -0.05, ages 3-8, p<0.05); arm span z-score +0.37 SD, p<0.0001.
• Drug was well tolerated with no discontinuations or serious adverse events related to study drug; data published in The New England Journal of Medicine and presented at ICCBH 2026.
• BridgeBio plans an EU Marketing Authorization Application in Q4 2026 and says it is prepared to launch oral infigratinib in the U.S. upon approval.