Intellia provides update on FDA clinical hold for nex-z after patient death in MAGNITUDE trial

Intellia Therapeutics, Inc.

Patient in MAGNITUDE Phase 3 trial for ATTR-CM died from septic shock secondary to perforated duodenal ulcer; autopsy supports clinical diagnoses.
Grade 4 liver transaminase elevations reported in <1% of >650 enrolled MAGNITUDE patients; all other cases resolved within weeks.
FDA clinical hold continues on MAGNITUDE (ATTR-CM) and MAGNITUDE-2 (ATTRv-PN) Phase 3 trials of nex-z.
No Grade 4 liver events reported in MAGNITUDE-2 (47 patients enrolled with ATTRv-PN).
Company plans to provide update after finalizing path forward with regulators.

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