BioCryst Pharmaceuticals Inc. (BCRX) has sought FDA approval for an oral granule formulation of once-daily Orladeyo in pediatric patients with hereditary angioedema of ages 2 to 11, and a decision is anticipated on December 12, 2025.Hereditary angioedema is a rare, inherited, and sometimes life-threatening condition with repeat episodes (attacks) of severe swelling in various parts of the body, including the stomach, limbs, face, and throat.Orladeyo in capsule formulation received FDA approval in December 2020 for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. The drug generated net revenue of $159.1 million in the third quarter of 2025, compared to $116.3 million in the year-earlier quarter.For children aged 2 to under 12 with hereditary angioedema, injectable therapies are currently the only FDA-approved options. With an estimated 500 pediatric patients in the U.S., oral granule formulation of once-daily Orladeyo, if approved, could address a key unmet need.BCRX closed Wednesday’s (November 26, 2025) trading at $7.10, up 3.65%.