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

MT Newswires Live00:02

Intellia Therapeutics (NTLA) said Monday that the US Food and Drug Administration has granted regenerative medicine advanced therapy designation to nexiguran ziclumeran for the treatment of hereditary transthyretin amyloidosis with polyneuropathy.

The development and commercialization of the therapy, also called nex-z and NTLA-2001, is being led by Intellia as part of a multi-target deal with Regeneron (REGN), the company added.

Nex-z is a "clustered regularly interspaced short palindromic repeats," or CRISPR-based investigational therapy designed to stop the production of the transthyretin protein with a single dose, the company said.

The FDA designation is meant to speed up the development and review of promising treatments, including gene therapies, for serious or life-threatening diseases. This designation offers benefits such as early discussions with the FDA, the potential for faster approval, and priority review for the product's biologics license application.

Shares of Intellia Therapeutics rose past 5% and Regeneron was up nearly 2% in recent trading activity.

Price: 15.14, Change: +0.84, Percent Change: +5.87

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