BridgeBio reported that its oral FGFR inhibitor infigratinib met the primary endpoint in a Phase 3 study for achondroplasia, producing statistically significant increases in annualized height velocity versus placebo. The topline data showed average height gains between roughly 1.74 and 2.1 cm per year depending on the analysis. BridgeBio said the drug was well tolerated overall; three cases of transient hyperphosphatemia were reported but did not require dose changes. The company plans regulatory discussions with the FDA and intends to pursue marketing applications later this year while accelerating development in hypochondroplasia. If approved, infigratinib would become an oral alternative to injectable therapies from BioMarin and Ascendis, increasing competition in a rare‑disease market that has seen recent approvals and near‑term launches.
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