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Durham drugmaker clears key FDA hurdle for potential billion-dollar therapy

BioCryst Pharmaceuticals won FDA approval to expand its lead drug Orladeyo to children ages 2–11, opening a new pediatric market for the hereditary angioedema treatment. Orladeyo generated most of BioCryst’s $468 million in 2025 revenue and is projected to reach $1 billion in annual sales by 2029.

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The Business Journals broke the news in United States on Sunday, December 14, 2025.
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