Clinical TrialJun 28, 2026, 04:01 PM
BridgeBio's Infigratinib Phase 3 Achondroplasia Data Published in NEJM
AI Summary
BridgeBio Pharma announced positive results from its Phase 3 PROPEL 3 study of oral infigratinib for achondroplasia, published in The New England Journal of Medicine and presented at ICCBH. The data showed statistically significant improvements in annualized height velocity (+1.74 cm/yr), height Z-score (+0.41 SD), and body proportionality, with the drug being well-tolerated. The company plans to submit an NDA to the FDA in Q3 2026 and an MAA to the EMA in H2 2026, anticipating a U.S. launch in early to mid-2027.
Key Highlights
- Phase 3 PROPEL 3 data for oral infigratinib published in NEJM and presented at ICCBH.
- Primary endpoint met: +1.74 cm/yr LS mean increase in annualized height velocity vs. placebo.
- Key secondary endpoint met: +0.41 SD increase in height Z-score at Week 52.
- Demonstrated statistically significant improvement in body proportionality (-0.05 LS mean difference).
- Showed statistically significant improvement in arm span (+0.37 SD vs. placebo).
- Oral infigratinib was well-tolerated with no discontinuations or serious adverse events.
- NDA submission to FDA planned for Q3 2026; MAA to EMA in H2 2026.
- US launch anticipated in early to mid-2027.
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