FDA lifts clinical hold on MAGNITUDE trial of nex-z in ATTR cardiomyopathy

Intellia Therapeutics/Nex-z (NTLA-2001)

The FDA removed the clinical hold on MAGNITUDE, the Phase 3 trial of nex-z in transthyretin amyloidosis with cardiomyopathy, allowing both nex-z Phase 3 trials to resume after late-2025 liver-safety holds. The hold was placed due to Grade 4 liver transaminases and bilirubin elevation in one patient, prompting enhanced monitoring and patient exclusion protocols that Intellia implemented before resumption.

• MAGNITUDE is Phase 3 trial of nex-z (nexiguran ziclumeran) in ATTR-CM
• Hold placed October 29, 2025 due to Grade 4 liver transaminases and bilirubin in one patient
• Intellia implemented enhanced liver lab monitoring, short-term steroid guidance, and additional patient exclusions
• Hold lifted March 2, 2026; both nex-z Phase 3 trials can now resume enrollment