BridgeBio Pharma Reports the US FDA Priority Review of Oral Infigratinib for Children with Achondroplasia
Shots:
- The US FDA has accepted NDA & granted Priority Review to infigratinib (PO) for the treatment of children with achondroplasia (PDUFA: Feb 4, 2027). BridgeBio is prepared to launch infigratinib upon approval
- Trial met its 1EP, with infigratinib improving annualized height velocity at Wk. 52 (mean treatment difference: +2.10cm/yr.) & its key 2EP of height Z-score. In children <8yrs.
- Infigratinib also significantly improved body proportionality in an exploratory analysis. The findings were published in The NEJM & simultaneously presented at the ICCBH 2026
Ref: Globenewswire | Image: BridgeBio Pharma | Press Release
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