Business
BioCryst Announces FDA Approval of ORLADEYO® (berotralstat) Oral Pellets, First and Only Oral Prophylactic Treatment for Patients with HAE Aged 2 to <12 Years
–ORLADEYO now first and only targeted oral prophylactic therapy for patients with HAE aged 2 and older–-Oral pellet formulation provides child-friendly method
About this update from Biocryst Pharmaceuticals, Inc.
– ORLADEYO now first and only targeted oral prophylactic therapy for patients with HAE aged 2 and older – -Oral pellet formulation provides child-friendly method of administration- –Showed early and sustained reductions in monthly attack rates in APeX-P– RESEARCH TRIANGLE PARK, N.C. , Dec. 12, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for the use of an oral pellet formulation of once-daily ORLADEYO® (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to
View stock analysis, news, and events for Biocryst Pharmaceuticals, Inc.