StocksMedium•6 October 2026•
1 min read
FDA Grants Priority Review for BridgeBio Achondroplasia Drug
Key Facts
1The US FDA accepted the New Drug Application for oral infigratinib for children with achondroplasia.
2The FDA set a PDUFA target action date of February 4, 2027.
The US FDA accepted the New Drug Application for oral infigratinib for children with achondroplasia. GlobeNewswire reported that the agency granted the application Priority Review, aimed at addressing a significant unmet medical need for a targeted oral therapeutic option.
The FDA set a PDUFA target action date of February 4, 2027, for its final decision on the treatment. The submission follows clinical data from the PROPEL 3 study, which demonstrated improvements in annualized height velocity and body proportionality in pediatric patients.