FDA Lifts Clinical Hold on Intellia’s MAGNITUDE-2 Phase 3 Trial for Nex-Z in ATTRv-PN
The FDA lifted the clinical hold on Intellia Therapeutics' Phase 3 MAGNITUDE-2 trial (NCT06672237) evaluating nexiguran ziclumeran (nex-z, NTLA-2001) for transthyretin amyloidosis with polyneuropathy (ATTRv-PN).
The hold was imposed on October 29, 2025, alongside MAGNITUDE trial for ATTR-CM, due to a grade 4 liver transaminase elevation and bilirubin increase in a MAGNITUDE patient, who died on November 5, 2025.
Intellia implemented enhanced liver laboratory test monitoring and increased MAGNITUDE-2 target enrollment from 50 to 60 patients.
Patient enrollment in MAGNITUDE-2 will resume as quickly as possible; MAGNITUDE hold remains in effect with ongoing FDA discussions.
Nex-z is an investigational CRISPR/Cas9 in vivo gene editing therapy, developed with Regeneron, targeting the TTR gene via lipid nanoparticle delivery.
Intellia CEO John Leonard expressed appreciation for FDA's review and focus on advancing the one-time treatment for ATTRv-PN.
Announcement made January 27, 2026, boosting Intellia shares by about 10%.