FDA lifts clinical hold on Intellia's MAGNITUDE-2 Phase 3 trial for ATTRv-PN; MAGNITUDE hold ongoing

Intellia Therapeutics, Inc.

FDA removed clinical hold on IND for MAGNITUDE-2 Phase 3 trial of nex-z for ATTRv-PN, imposed Oct 29, 2025 after Grade 4 liver event and patient death.
Intellia to resume patient enrollment with enhanced liver safety monitoring; target enrollment increased from ~50 to ~60 patients.
FDA engagement ongoing for clinical hold on MAGNITUDE Phase 3 trial for ATTR-CM; no update on path forward yet.

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