FDA Grants Priority Review to BridgeBio's Dwarfism Drug Filing

What happened: The FDA accepted BridgeBio Pharma's filing for oral infigratinib to treat children with achondroplasia, the most common form of dwarfism, and granted it priority review. Key numbers: Priority review targets action within six months versus the standard 10. Final decision expected by Feb. 4, 2027. Why it matters: If approved, infigratinib could become the first oral therapy for achondroplasia, differing from injected treatments Voxzogo and Yuviwel. BridgeBio plans an EU filing before year end, and the three near-term candidates could diversify revenue beyond Attruby.

The FDA accepted BridgeBio Pharma's filing for oral infigratinib to treat children with achondroplasia, the most common form of dwarfism, and granted it priority review.

If approved, infigratinib could become the first oral therapy for achondroplasia, differing from injected treatments Voxzogo and Yuviwel. BridgeBio plans an EU filing before year end, and the three near-term candidates could diversify revenue beyond Attruby.