STAR-0310

November 4, 2026: BioCryst Pharmaceuticals (NASDAQ: BCRX) reported Q3 2026 results and a business update highlighted by an FDA catalyst for ORLADEYO (berotralstat) in hereditary angioedema (HAE). In October, the FDA approved the supplemental NDA for ORLADEYO 150 mg oral pellets for HAE patients aged 12 and older; the pellet launch for children aged 2 to under 12 began in August, with the company saying early reimbursement and new prescriptions were ahead of expectations.

For navenibart, a long-acting plasma kallikrein inhibitor in HAE, the fully enrolled pivotal ALPHA-ORBIT study and ORBIT-EXPANSE extension remain on track for top-line results at six- and twelve-month endpoints in Q3 2027.

For BCX17725, a KLK5 inhibitor for Netherton syndrome, Part 4 of the Phase 1 trial has been enrolled, and initial patient data are expected by the end of 2026.

BioCryst also said it discontinued STAR-0310, its early-stage atopic dermatitis program, to focus on rare diseases.

Financially, Q3 total revenue was $180.3 million, including ORLADEYO revenue of $174.8 million; operating profit was $53.3 million and non-GAAP operating profit was $86.5 million. The company maintained 2026 ORLADEYO revenue guidance of $625 million-$645 million and raised total revenue guidance to $715 million-$730 million.