BridgeBio Pharma has reported positive Phase 3 results for its oral infigratinib (BBP-831) in children with achondroplasia, demonstrating statistically significant increases in annualized height velocity and, importantly, the first statistically significant improvement in body proportionality against placebo in a randomized trial for this condition. The PROPEL 3 trial showed a mean treatment difference in annualized height velocity of +2.10 cm/year vs placebo at week 52, and a key secondary endpoint showed a statistically significant improvement in upper-to-lower body proportionality, with a least squares (LS) mean treatment difference of -0.05 (p<0.05) in children under 8 years. These results support the potential of infigratinib as a first oral, once-daily, FGFR3-targeted therapy for achondroplasia, with U.S. and EU regulatory filings planned in the second half of 2026 and a favorable safety profile to date. Earlier Phase 2 data also showed sustained height gains and improved body...
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