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Why Intellia Therapeutics (NTLA) Is Down After FDA Halts Key CRISPR Trial Over Safety Concerns – And What's Next

Simply Wall St·01/07/2026 03:32:45
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  • In late 2025, Intellia Therapeutics paused dosing and enrollment in its late-stage MAGNITUDE trials for nexiguran ziclumeran after a patient death from severe liver-related side effects led the FDA to place the program on clinical hold, prompting the company to suspend milestone guidance while it works with regulators on a path forward.
  • This setback directly affects Intellia’s leading in vivo CRISPR program and raises fresh questions about liver safety risks across its broader gene-editing platform.
  • We’ll now explore how the FDA clinical hold on nexiguran ziclumeran may reshape Intellia’s investment narrative and risk-reward profile.

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Intellia Therapeutics Investment Narrative Recap

To own Intellia today, you need to believe that in vivo CRISPR can still translate into a viable ATTR and HAE treatment business despite substantial clinical and regulatory uncertainty. The FDA hold on nexiguran ziclumeran directly challenges the key near term catalyst, since MAGNITUDE outcomes were central to validating Intellia’s platform, and it now also amplifies the company’s biggest risk around safety setbacks in a highly concentrated late stage pipeline.

The most relevant recent update is Intellia’s November 2025 disclosure that longer term Phase 1 ATTR data for nexiguran ziclumeran showed disease stabilization and deep TTR reduction while MAGNITUDE remained under FDA hold. Those early results may still matter for how regulators and clinicians assess benefit versus risk if Intellia can propose protocol changes or new monitoring strategies, but until the hold is resolved, the timing and shape of any future catalyst tied to nexiguran ziclumeran remains uncertain.

Yet behind the scientific promise, investors should be aware that...

Read the full narrative on Intellia Therapeutics (it's free!)

Intellia Therapeutics' narrative projects $648.6 million revenue and $104.2 million earnings by 2028.

Uncover how Intellia Therapeutics' forecasts yield a $22.43 fair value, a 131% upside to its current price.

Exploring Other Perspectives

NTLA 1-Year Stock Price Chart
NTLA 1-Year Stock Price Chart

Seven members of the Simply Wall St Community currently place Intellia’s fair value anywhere between US$16.90 and US$234.82, underscoring how far opinions can diverge. When you set those views against the current FDA clinical hold on its lead asset, it becomes even more important to weigh multiple scenarios for trial outcomes and funding needs before forming your own view.

Explore 7 other fair value estimates on Intellia Therapeutics - why the stock might be a potential multi-bagger!

Build Your Own Intellia Therapeutics Narrative

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.