- Phase 3 PROPEL 3 data published today in NEJM were simultaneously presented at ICCBH in a late-breaking oral presentation; presentation includes new arm span Z-score data showing a statistically significant improvement versus placebo (LS mean +0.37 SD; p<0.0001), the first and only statistically significant placebo-controlled arm span result reported for an achondroplasia trial at 52 weeks
- This is the first and only Phase 3 data for an achondroplasia clinical study published in The New England Journal of Medicine (NEJM), marking BridgeBio’s second NEJM publication in achondroplasia and fourth NEJM publication overall in the last three years
- The data includes the largest mean increase in AHV compared to placebo reported in any Phase 3 achondroplasia study (+2.1 cm/year observed mean improvement)
- Oral infigratinib is the only therapy to demonstrate statistically significant improvement in body proportionality in a Phase 3 achondroplasia study, with a LS mean treatment difference of –0.05 in children ages 3 to 8 years (p<0.05)
- Oral infigratinib was well tolerated, with no discontinuations or serious adverse events related to study drug
- BridgeBio intends to submit an NDA to the FDA in the third quarter of 2026 with launch anticipated in early to mid 2027, and an MAA to the EMA in the second half of 2026
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