BridgeBio’s Infigratinib Signals Breakthrough in Pediatric Achondroplasia Trial
13.02.2026 - 11:21:04
BridgeBio Pharma announced yesterday the successful completion of the pivotal Phase 3 PROPEL 3 study evaluating Infigratinib. The data demonstrate meaningful clinical benefits in children with achondroplasia, the most common form of dwarfism. With the primary endpoint reached, a potential regulatory filing for the oral therapy moves closer to market approval.
- Strong growth: Annual growth velocity increased by 1.74 cm compared with the placebo group.
- Milestone: First statistically significant improvement in body proportionality observed.
- Safety: Well tolerated with no serious treatment-related adverse events.
- Timeline: Submissions to FDA and EMA for regulatory approval are planned for the second half of 2026.
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