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Intellia Therapeutics' Nex-z Receives FDA Regenerative Medicine Advanced Therapy Designation

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News
rttnewslogo20mar2024

Intellia Therapeutics, Inc. (NTLA), Wednesday announced that the U.S. Food and Drug Administration has granted Regenerative Medicine Advanced Therapy designation to nexiguran ziclumeran, also known as nex-z or NTLA-2001, for the treatment of transthyretin or TTR amyloidosis with cardiomyopathy.

The designation was based on the findings of interim Phase 1 clinical data, which demonstrated that the administration of nex-z led to consistent, deep and long-lasting TTR reduction.

Nex-z has been granted the designations by the U.S. FDA for both cardiomyopathy and polyneuropathy, where it showed unprecedented rapid, durable and consistent reductions in serum TTR after a single dose.

Nex-z has also been granted Orphan Drug Designation by the U.S. FDA and European Commission.

In the pre-market hours, Intellia's stock is trading at $8.90, up 1.95 percent on the Nasdaq.

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