NTLA Stock Jumped 13% Today – What Is The Latest FDA Action All About?

• The trial is for the use of Nexiguran Ziclumeran (Nex-Z) in patients with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN), a rare nerve-damaging disease.
• The Phase 3 trial was suspended after a patient dosed with Nex-Z in a related trial experienced a severe liver enzyme issue.
• The decision clears the way for Intellia to resume patient enrollment in the study.

Shares of Intellia Therapeutics (NTLA) gained more than 13% on Tuesday morning as the U.S. Food and Drug Administration (FDA) lifted the clinical hold on the MAGNITUDE-2 Phase 3 trial of Nexiguran Ziclumeran (Nex-Z) for patients with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN), a rare nerve-damaging disease.

A clinical hold is a delay or suspension of an ongoing clinical trial due to serious safety concerns.

Why Did FDA Suspend The Trial?

The clinical hold was imposed in late October 2025 after a patient dosed with Nex-Z in a related trial experienced a severe liver enzyme issue that met the protocol-defined pausing criteria. Since then, Intellia has worked with the FDA to implement study modifications, including enhanced monitoring of liver-related lab tests.

“With the clinical hold for MAGNITUDE-2 lifted, our team is focused on resuming patient enrollment as quickly as possible as we seek to advance this potential one-time treatment option for people living with ATTRv-PN,” said John Leonard, Intellia’s President and CEO.

MAGNITUDE-2 is a randomized placebo-controlled study assessing the safety and effectiveness of Nex-Z in patients with ATTRv-PN. Following a protocol update, Intellia increased target enrollment to about 60 patients.

What’s Next?

The decision clears the way for Intellia to resume patient enrollment in the study. Intellia said discussions with the FDA are ongoing regarding the separate MAGNITUDE Phase 3 trial of Nex-Z in patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM), and the company will provide an update once a path forward is finalized.

Nex-Z is a gene-editing therapy designed to permanently inactivate the TTR gene, which is key in producing a protein called transthyretin. The program has received Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA, highlighting its potential to address serious unmet medical needs.

How Did Retail React?

Retail sentiment on Stocktwits turned ‘extremely bullish’ from ‘bullish’ a day earlier, accompanied by ‘high’ message volumes. NTLA was among the top trending tickers on the platform at the time of writing.

One user believes the development should be good for the sector.

Another user expects the stock to cross $20 by the end of the trading session. It is currently trading close to $15.

The stock has gained nearly 50% over the past year.

Read also: What Triggered QBTS Stock’s Pre-Market Rally Today?

For updates and corrections, email newsroom[at]stocktwits[dot]com.

Share

·

Add us on