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Intellia paused its Phase 3 trials due to severe liver toxicity in a patient, prompting an FDA clinical hold and a 40% stock drop.
Intellia Therapeutics paused its Phase 3 trials for nexiguran ziclumeran after a patient in the MAGNITUDE trial suffered severe liver toxicity, triggering a protocol-defined halt.
The FDA placed a clinical hold on both trials following a serious adverse event involving Grade 4 liver transaminase elevation and elevated bilirubin.
The news caused Intellia’s stock to drop sharply, with shares falling over 40% in two days.
The company is working with regulators to address safety concerns, but no timeline for resuming trials has been provided.
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Intellia suspendió sus ensayos de fase 3 debido a una grave toxicidad hepática en un paciente, lo que provocó una suspensión clínica de la FDA y una caída del 40% en las existencias.