Low-dose infigratinib - (PROPEL3)

June 28, 2026: BridgeBio Pharma, Inc. (NASDAQ: BBIO) announced positive Phase 3 PROPEL 3 pivotal results for oral infigratinib in children with achondroplasia, published as an original research article in The New England Journal of Medicine and presented as a late-breaking oral presentation at ICCBH 2026.

PROPEL 3 met its primary endpoint (change from baseline in annualized height velocity): LS mean treatment difference vs placebo +1.74 cm/year (p<0.0001); observed mean difference +2.10 cm/year (p<0.0001). It also met a key secondary endpoint (change from baseline in height Z-score at Week 52; p<0.0001), with LS mean increase +0.41 SD on treatment. In a pre-specified exploratory analysis, infigratinib showed statistically significant improvement in body proportionality vs placebo in children <8 years (LS mean treatment difference -0.05; p<0.05). Additional ICCBH data reported arm span improvement vs placebo of +0.37 SD (p<0.0001).

Safety/tolerability: no discontinuations or serious AEs related to study drug; hyperphosphatemia in 3 cases (4%), mild/transient/asymptomatic.

Regulatory next steps: BridgeBio plans an FDA NDA submission in Q3 2026 and an EMA MAA submission in 2H 2026; anticipates U.S. launch in early–mid 2027.