FDA Halts Intellia Therapeutics Gene-Editing Trials After Serious Liver Incident
The Food and Drug Administration (FDA) has placed a clinical hold on two late-stage trials run by Intellia Therapeutics. These trials test a one-time CRISPR-based therapy, nexiguran ziclumeran (nex-z), for the rare disease transthyretin amyloidosis. The hold follows a serious adverse event: a patient developed grade 4 liver enzyme elevations and high bilirubin levels after…