Intellia Therapeutics Receives Key Regulatory Clearance for Clinical Trial
Intellia Therapeutics has received crucial regulatory clearance from the U.S. FDA to lift a clinical hold on its MAGNITUDE-2 Phase 3 study for NTLA-2001 (Nex-z), a CRISPR-based therapeutic for hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). This follows a previous setback due to a serious adverse event in a related trial. The company has implemented a revised protocol with enhanced patient monitoring and an increased enrollment target, though the original MAGNITUDE trial for ATTR-CM remains on hold.
https://www.ad-hoc-news.de/boerse/news/ueberblick/intellia-therapeutics-receives-key-regulatory-clearance-for-clinical-trial/68554686