FDA Clears Intellia Therapeutics' MAGNITUDE-2 Trial, but Cardiomyopathy Study Remains on Hold

The FDA has cleared the clinical hold on Intellia Therapeutics' MAGNITUDE-2 Phase 3 trial in hereditary transthyretin amyloidosis with polyneuropathy, allowing the late-stage study of the CRISPR-based gene editing therapy to resume with enhanced liver safety monitoring protocols. However, the clinical hold remains in place for the related cardiomyopathy study, leaving part of the program subject to regulatory uncertainty. The partial resolution of the hold gives Intellia a path to continue a pivotal trial in polyneuropathy.