FDA extends PDUFA goal date for BioCryst's ORLADEYO pediatric NDA to Dec 12, 2025

BIOCRYST PHARMACEUTICALS INC

FDA determined submission of additional final reports and formulation data is a major amendment, extending review by three months.
New PDUFA target action date set for December 12, 2025, after original goal date extended.
NDA seeks approval of once-daily ORLADEYO oral granules for HAE in pediatric patients aged 2 to 11 years.

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