BioCryst (BCRX) Gains FDA Approval for Orladeyo Oral Pellets in HAE Patients Aged 12 and Older

BioCryst Pharmaceuticals Inc. (BCRX) said Wednesday that the U.S. Food and Drug Administration approved its oral pellet formulation of Orladeyo for preventing hereditary angioedema attacks in patients aged 12 and older. The approval was supported by manufacturing and quality data and evidence of the formulation's safety and tolerability compared with Orladeyo capsules, the company said. Orladeyo capsules were approved in the U.S. in December 2020 for patients aged 12 and older. In December 2025, the FDA approved the oral pellet formulation for children aged 2 to under 12. BioCryst shares rose nearly 2% in pre-market trading on the Nasdaq after closing at $7.94 on Tuesday.