Intellia Therapeutics' stock soared 5.01% during intraday trading on Monday, reflecting a significant positive move for the biopharmaceutical company.
The surge follows the U.S. Food and Drug Administration's decision to remove the clinical hold on the Investigational New Drug application for the company's MAGNITUDE Phase 3 clinical trial. The trial evaluates the efficacy and safety of nexiguran ziclumeran (nex-z), a gene-editing therapy, for patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM), a serious heart disease.
The clinical hold was initially imposed in late October 2025 after a patient in the trial experienced severe liver complications. Intellia has aligned with the FDA on mitigation measures, including enhanced liver test monitoring and updated patient exclusion criteria, allowing the critical late-stage trial to resume enrollment and progress.