BioCryst Pharmaceuticals Inc. has announced new data from the ongoing APeX-P clinical trial evaluating ORLADEYO® (berotralstat) in pediatric patients with hereditary angioedema $(HAE)$ aged 2 to under 12 years. The results, presented at the Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in November 2025, show early and sustained reductions in monthly HAE attack rates over one year of treatment with once-daily ORLADEYO oral granules. The company also highlighted findings on the negative psychosocial impact of HAE and emergency care visits on children and their caregivers. A New Drug Application for ORLADEYO oral granules as prophylaxis in this pediatric population is currently under review by the U.S. Food and Drug Administration, with a decision expected by the end of 2025. If approved, ORLADEYO would be the first targeted oral prophylactic therapy for HAE patients aged 2 to under 12 years.