CSL Posts Encouraging Data From Garadacimab In Severe Swelling Attacks

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  • 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.
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