BridgeBio Pharma, Inc. (BBIO) on Thursday reported positive topline results from its Phase 3 PROPEL 3 study evaluating oral infigratinib in children with achondroplasia, a genetic bone growth disorder and the most common form of dwarfism, sending shares up more than 14% in pre-market trading.
The one-year pivotal trial enrolled children aged 3 to less than 18 years with open growth plates. The study met its primary endpoint, demonstrating a statistically significant improvement in annualized height velocity (AHV) at Week 52 compared with placebo. The mean treatment difference versus placebo was +2.10 cm per year, with a least squares (LS) mean difference of +1.74 cm per year.
Consistent with the primary outcome, the secondary endpoint of absolute AHV at Week 52 also showed significant improvement. Patients treated with infigratinib achieved an LS mean absolute AHV of 5.96 cm per year, compared with 4.22 cm per year for placebo — the highest LS mean absolute AHV reported to date in a randomized achondroplasia trial, the company said.
Further, oral infigratinib was well tolerated, with no discontinuations or serious adverse events related to the drug.
BridgeBio said it plans to submit a New Drug Application (NDA) and Marketing Authorization Application (MAA) in the second half of 2026 for achondroplasia. The company also intends to accelerate development of infigratinib in hypochondroplasia and is currently enrolling patients in the observational run-in for a Phase 3 trial.
BridgeBio shares closed Wednesday at $73.33, up 1.19%.
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