Cathie Wood’s Biotech Bet Intellia Secured An FDA Priority Review For Rare Genetic Disorder Therapy – Retail Sees Upside In NTLA’s Platform

• The FDA set its PDUFA date for March 10, 2027.
• The agency also told Intellia it does not currently plan to hold an advisory committee meeting.
• ARK Invest purchased roughly $2.5 million worth of Intellia shares across several transactions during the first four trading days of September.

Intellia Therapeutics (NTLA) was on investors’ radar on Tuesday after the U.S. Food and Drug Administration (FDA) granted priority review to its experimental gene-editing treatment for a rare genetic disease.

The development comes just days after Cathie Wood’s ARK Invest increased its stake in the firm. ARK purchased roughly $2.5 million worth of Intellia shares across several transactions during the first four trading days of September.

At the time of writing, NTLA shares were down 0.8%.

FDA Sets March 2027 Decision Date

The FDA accepted Intellia’s Biologics License Application for lonvoguran Ziclumeran (lonvo-z), and set a decision date for March 10, 2027. The agency also told Intellia it does not currently plan to hold an advisory committee meeting.

Priority Review shortens the FDA’s standard review timeline for drugs that could significantly improve treatment for serious conditions.

Why The FDA Granted Priority Review

The FDA application is supported by Intellia’s 80-patient Phase 3 HAELO trial. A single dose of lonvo-z reduced the average monthly HAE attacks by 87% compared with placebo. Intellia said it observed no serious adverse events in the lonvo-z group through the primary observation period.

If approved, Intellia said lonvo-z could become the world’s first in vivo Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) therapy, which edits genes directly inside a patient’s body, as well as the only one-time treatment for hereditary angioedema (HAE).

HAE is a rare genetic disease that causes unpredictable and potentially life-threatening swelling attacks. It affects roughly one in 50,000 people, according to the biotech firm.

Retail Bets On NTLA’s Platform

Retail sentiment surrounding NTLA on Stocktwits turned ‘bullish’ from ‘bearish’ a day earlier, amid ‘high’ message volumes.

One user said the real upside is if one breakthrough therapy validates an entire technology platform.

Another user said, “the more people understand the vast value of this platform, the more the share price will increase.”

NTLA shares are up over 35% so far this year.

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