WASHINGTON (dpa-AFX) - Intellia Therapeutics, Inc. (NTLA) announced the FDA has cleared the company's Investigational New Drug application for NTLA-2001 for the treatment of transthyretin amyloidosis with cardiomyopathy. The global Phase 3 study of NTLA-2001, an in vivo CRISPR-based gene editing candidate, is anticipated to initiate by year-end 2023.
'The FDA clearance of the NTLA-2001 IND application allows us to initiate a pivotal Phase 3 trial in the United States, marking the first in vivo CRISPR-based candidate to begin late-stage clinical development. This is another important step forward for Intellia and our collaborator, Regeneron,' said Intellia CEO John Leonard.
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