CSL Posts Encouraging Data From Garadacimab In Severe Swelling Attacks

CSL CSLLY announced topline Phase 3 results for garadacimab (CSL312) for hereditary angioedema (HAE).
HAE is a rare genetic condition that causes painful, debilitating, unpredictable episodes of swelling of the abdomen, larynx, face, and extremities, among other body areas.
The study met its primary and secondary efficacy objectives and demonstrated favorable safety and tolerability.
CSL aims to begin filing with global health authorities at the end of the current fiscal year for full approval.
Full results from the study will be presented at an upcoming scientific congress and published in a peer-reviewed journal.
Garadacimab is a novel Factor XIIa-inhibitory monoclonal antibody (FXIIa mAb) currently in Phase 3 clinical development as a new type of once-monthly subcutaneous prophylactic treatment for attacks related to HAE.
Garadacimab uniquely inhibits the plasma protein FXIIa. When FXIIa is activated, it initiates the cascade of events leading to edema formation. By targeting FXIIa, garadacimab inhibits the HAE cascade.
The drug has received orphan-drug designation from the FDA and European Medicines Agency.
CSL is also investigating garadacimab for other indications beyond HAE, where FXIIa inhibition may play an essential role in improving clinical outcomes, including pulmonary fibrosis.
Price Action: CSLLY shares are trading lower by 3.18% at $100.82 on the last check Wednesday.