Intellia Therapeutics, Inc. 8-K

What Happened
Intellia Therapeutics announced on January 27, 2026 that the U.S. Food and Drug Administration has removed the clinical hold on the MAGNITUDE-2 Phase 3 trial of nexiguran ziclumeran (nex‑z) for hereditary transthyretin amyloidosis with polyneuropathy (ATTRv‑PN). The company said it has aligned with the FDA on certain study modifications and mitigation measures, including enhanced liver laboratory monitoring, and is working with investigators and regulators to resume enrollment as quickly as possible. The related MAGNITUDE Phase 3 trial for ATTR cardiomyopathy (ATTR‑CM) remains on clinical hold while discussions with the FDA continue.

Key Details

• Date of announcement: January 27, 2026. Original FDA clinical hold was imposed October 29, 2025.
• Drug and trials: nexiguran ziclumeran (nex‑z); MAGNITUDE‑2 = Phase 3 for ATTRv‑PN (hold lifted); MAGNITUDE = Phase 3 for ATTR‑CM (hold remains).
• Safety issue prompting hold: a patient dosed in MAGNITUDE had Grade 4 liver transaminase elevations and increased total bilirubin and subsequently died, triggering protocol pause and FDA action.
• Agreed mitigations: study modifications and enhanced safety monitoring of liver laboratory tests; Intellia is engaging ethics committees and international authorities to restart enrollment.

Why It Matters
For investors, the lift of the MAGNITUDE‑2 hold is a material step that allows Intellia to restart testing of nex‑z in the ATTRv‑PN population, which could re‑start the development timeline for that indication. However, the unresolved hold on the ATTR‑CM trial and the serious liver adverse event that prompted the holds are significant safety and regulatory risks that could affect timelines, data readouts, and the overall outlook for nex‑z. The company provided forward‑looking statements and said it will update the market when there is alignment with regulators on the path forward for the ATTR‑CM program.