BridgeBio's oral drug infigratinib met the primary endpoint in the PROPEL 3 Phase 3 trial, achieving a statistically significant 2.1 cm/year improvement in annualized height velocity (AHV) over placebo in children with achondroplasia.123
Secondary endpoints included 5.96 cm/year absolute height growth vs. 4.22 cm/year for placebo, and significant improvement in body proportionality in children under 8 (LS mean decrease of 0.05).13
The drug was well-tolerated with no serious adverse events, discontinuations, or dose reductions; three mild cases of hyperphosphatemia.23
BridgeBio plans regulatory submissions in the US and Europe in H2 2026, positioning infigratinib as an oral alternative to injectables like BioMarin's Voxzogo.123
This marks BridgeBio's third consecutive Phase 3 success.6
Additional trials ongoing for infants/toddlers with achondroplasia and Phase 3 enrollment for hypochondroplasia.2
Sources:
1. https://www.fiercebiotech.com/biotech/bridgebio-preps-approval-push-after-dwarfism-drug-increases-height-children-phase-3
2. https://medcitynews.com/2026/02/bridgebio-pharma-achondroplasia-dwarfism-oral-fgfr3-inhibitor-infigratinib-bbio/
3. https://www.clinicaltrialsarena.com/news/bridgebio-achondroplasia-dwarfism-infigratinib-phase-iii-results/
6. https://www.statnews.com/2026/02/12/bridgebio-dwarfism-achondroplasia-infigratinib/