# FDA Grants Priority Review for Intellia Therapeutics CRISPR Therapy

- URL: https://stocks.freetheai.org/news/fda-grants-priority-review-for-intellia-therapeutics-crispr-therapy-7e368b
- Published: 2026-10-12T11:00:00Z
- Category: company_news; sentiment: bullish; impact: high
- Symbols: [NASDAQ:NTLA](https://stocks.freetheai.org/symbols/NASDAQ-NTLA)
- Written by our AI from expert market sources across the web for FreeTheAI Stocks, built by Vibhek Soni
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Intellia Therapeutics, Inc. (NASDAQ:NTLA) received Priority Review status from the U.S. Food and Drug Administration for its Biologics License Application for lonvoguran ziclumeran, an in-vivo CRISPR therapy. The regulatory decision sets a Prescription Drug User Fee Act target action date of March 10, 2027. Following the announcement, shares traded up 3.73% to $13.07.

The Priority Review designation accelerates the regulatory assessment period for the gene-editing treatment. At the same time, institutional interest remains active as investment manager ARK purchased approximately 96,308 shares valued at about $1.2 million. This purchase marks the 50th consecutive session of share accumulation for the stock as part of ARK's broader genomics portfolio strategy.

Investors will look toward the upcoming FDA PDUFA date on March 10, 2027, for the official approval decision on lonvoguran ziclumeran. Market participants will also monitor ongoing portfolio activity and clinical milestone developments leading up to the regulatory deadline.

## Key points

- The FDA accepted Intellia Therapeutics Biologics License Application for lonvoguran ziclumeran under Priority Review.
- The FDA set a Prescription Drug User Fee Act target decision date of March 10, 2027, for the CRISPR therapy.
- ARK bought approximately 96,308 shares of NTLA worth around $1.2 million in its 50th consecutive session of buying.
- Shares of Intellia Therapeutics rose 3.73% to trade at $13.07 following the regulatory news.

## Questions and answers

### What is the FDA PDUFA date for Intellia Therapeutics?

The U.S. Food and Drug Administration set a PDUFA target action date of March 10, 2027, for Intellia Therapeutics Biologics License Application for lonvoguran ziclumeran.

### How many NTLA shares did ARK recently purchase?

ARK bought approximately 96,308 shares of Intellia Therapeutics worth about $1.2 million, extending its buying streak to 50 consecutive sessions.

### What therapy did the FDA accept for Priority Review?

The FDA accepted the Biologics License Application with Priority Review for lonvoguran ziclumeran, an in-vivo CRISPR therapy developed by Intellia Therapeutics.