Garadacimab (CSL312)

July 27, 2026: CSL (ASX:CSL; OTC: CSLLY) reported positive top-line results from a multicenter, open-label Phase 3b study of ANDEMBRY (garadacimab-gxii) for prevention of hereditary angioedema (HAE) attacks in children aged 2–11 years. The company said ANDEMBRY showed a favorable safety and tolerability profile consistent with prior studies, and treatment response was observed across the population, with the majority of participants remaining attack-free over the 12-month treatment period. Dosing was 100 mg once monthly in ages 6–11 (n=16) and 100 mg every two months in ages 2–5 (n=6).

CSL plans to begin submitting regulatory filings to health authorities in the first half of the company’s fiscal year to support an expanded pediatric indication for ages 2–11 (ANDEMBRY is already approved in over 40 countries for patients aged 12+). Full study results are planned for presentation at an upcoming scientific congress and submission to a peer-reviewed journal.