Intellia Therapeutics Clears Key Regulatory Obstacle for Gene Therapy Trial

A significant regulatory roadblock has been removed for Intellia Therapeutics. The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the company’s pivotal MAGNITUDE-2 Phase 3 study, allowing the biotech firm to resume work on its CRISPR-based gene editing treatment. The decision, announced on January 27, provides clarity after months of uncertainty, though broader regulatory discussions are ongoing.

The green light permits Intellia to continue developing its drug candidate, Nexiguran Ziclumeran (nex-z), for hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). This follows an agreement between the company and regulators to implement enhanced safety monitoring protocols, with a specific focus on liver function. Company leadership has stated it will move swiftly to restart patient recruitment and dosing.