FDA Lifts Clinical Hold on Intellia’s MAGNITUDE-2 Trial for ATTRv-PN — Intellia Therapeutics, Inc.

Event summary

FDA removed the clinical hold on Intellia’s MAGNITUDE-2 Phase 3 trial for ATTRv-PN on January 27, 2026.
The trial will resume patient enrollment and dosing with enhanced safety monitoring for liver laboratory tests.
The target enrollment for MAGNITUDE-2 has increased from 50 to 60 patients.
FDA engagement continues regarding the clinical hold on the MAGNITUDE Phase 3 trial for ATTR-CM.

The big picture

The FDA’s decision to lift the clinical hold on the MAGNITUDE-2 trial is a critical step for Intellia’s CRISPR-based therapy, nex-z, in treating ATTRv-PN. This move aligns with the broader trend of regulatory bodies cautiously advancing gene-editing therapies while ensuring patient safety. The ongoing engagement with the FDA on the MAGNITUDE trial for ATTR-CM highlights the regulatory scrutiny faced by innovative treatments in the biotech sector.

What we're watching

Regulatory Alignment: Whether Intellia can achieve alignment with the FDA on the MAGNITUDE trial for ATTR-CM.
Trial Execution: The pace at which Intellia resumes and completes the MAGNITUDE-2 trial.
Safety Monitoring: How enhanced safety monitoring impacts the trial’s timeline and outcomes.