BridgeBio Plans Regulatory Filings for Infigratinib After Phase III Success in Achondroplasia

BridgeBio Pharma is preparing to approach regulators following positive Phase III results for infigratinib in achondroplasia. In the pivotal PROPEL3 trial (NCT06164951), once-daily oral infigratinib met its primary endpoint, delivering a superior 2.10cm/year increase in annualised height velocity (AHV) from baseline versus placebo. The least squares mean treatment difference was 1.74cm/year.

At 52 weeks, treated patients achieved 5.96cm/year growth compared with 4.22cm/year in the placebo group. An exploratory analysis in children under eight showed improved body proportionality, marking a first in a randomised achondroplasia study, although this was not significant across the full population.

The FGFR1-3 inhibitor was generally well tolerated, with no treatment-related serious adverse events. BridgeBio plans regulatory discussions in H2 2026.

If approved, infigratinib would compete with BioMarin Pharmaceutical’s injectable Voxzogo and Ascendis Pharma’s TransCon CNP, while offering the advantage of oral dosing.

16-02-2026