FDA expands BioCryst’s Orladeyo to young children

The FDA approved an oral pellet version of BioCryst’s Orladeyo (berotralstat) to prevent hereditary angioedema (HAE) attacks in kids aged 2 to under 12. Orladeyo was previously approved as a once-daily capsule for ages 12+. The new “sprinkle-like” pellets can be mixed with soft food or swallowed with liquid, and BioCryst expects U.S. availability around April 2026 while keeping pricing parity across doses.

WHY THIS MATTERS FOR TRADERS

Addressable market expands: More eligible patients (pediatric) plus an easier-to-take formulation can support growth expectations for BioCryst’s flagship product.

Competitive pressure in HAE: “First oral prophylactic” for younger kids is a differentiator versus injectable prophylaxis options for that age group.

Prici ...