BridgeBio’s Infigratinib Signals Breakthrough in Pediatric Achondroplasia Trial

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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