$BBIO (BridgeBio Pharma) — 8-K: FDA accepts BridgeBio's oral infigratinib NDA with Priority Review, PDUFA date February 4, 2027

The FDA accepted BridgeBio's NDA for oral infigratinib for children with achondroplasia under Priority Review, with a PDUFA target action date of February 4, 2027. The Phase 3 PROPEL 3 study met its primary endpoint of change from baseline in annualized height velocity at Week 52 with a mean treatment difference of +2.10 cm/year and an LS mean treatment difference of +1.74 cm/year, both p<0.0001, and met its key secondary endpoint of height Z-score change. In a pre-specified exploratory analysis in children younger than 8 years, infigratinib showed a statistically significant improvement in body proportionality versus placebo, with a mean difference of -0.05 and an arm span z-score improvement of +0.37 SD. If approved, oral infigratinib would be the first and only approved oral therapy for children with achondroplasia, and BridgeBio said it is prepared to launch upon approval.

The FDA accepted BridgeBio's NDA for oral infigratinib for children with achondroplasia under Priority Review, with a PDUFA target action date of February 4, 2027. The Phase 3 PROPEL 3 study met its p