BridgeBio reports positive Phase 3 infigratinib results in achondroplasia; NDA/MAA planned H2 2026

BridgeBio Pharma, Inc.

PROPEL 3 met primary endpoint: change from baseline in AHV at Week 52 (p<0.0001); mean treatment difference +2.10 cm/year.
First statistically significant improvement in body proportionality vs placebo in children <8 years (LS mean -0.05, p<0.05).
Key secondary endpoint height Z-score (achondroplasia reference) LS mean increase +0.41 SD on treatment (p<0.0001).
No discontinuations or serious AEs related to study drug; 3 cases (4%) mild transient hyperphosphatemia, no FGFR1/2 AEs.
NDA and MAA submissions for achondroplasia planned in second half of 2026; accelerate hypochondroplasia development.

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