Intellia Therapeutics (NTLA) Is Down 50.7% After FDA Halts MAGNITUDE Trials on Safety Concerns – Has The Bull Case Changed?

• In late October 2025, Intellia Therapeutics announced that the FDA had placed a clinical hold on its Phase 3 MAGNITUDE and MAGNITUDE-2 trials for the gene-editing therapy nexiguran ziclumeran, following a serious liver-related adverse event in a patient. This development brings significant regulatory uncertainty and highlights the risks associated with late-stage clinical trials for novel gene-editing therapies.
• We'll examine how the FDA's clinical hold and emerging safety concerns could reshape Intellia's investment outlook and clinical development trajectory.

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Intellia Therapeutics Investment Narrative Recap

Owning Intellia Therapeutics requires conviction in the transformative potential of in vivo CRISPR gene editing and confidence that late-stage trials for nexiguran ziclumeran (nex-z) will resume and succeed. The FDA’s recent clinical hold on these pivotal studies is now the chief near-term catalyst and the biggest risk, as it introduces regulatory uncertainty and the possibility of significant delays or safety-driven setbacks.

The most relevant announcement is Intellia’s October 29 update that the FDA verbally placed the MAGNITUDE and MAGNITUDE-2 trials on clinical hold due to a Grade 4 liver-related adverse event. This action has direct implications for timelines, potential future earnings, and increases the importance of how efficiently management can address safety concerns and regulatory requirements.

Conversely, investors should be aware that high R&D spend, coupled with no near-term revenue from approved products, means the company’s funding risk may rise if timelines slip or new setbacks emerge…

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

Intellia Therapeutics' outlook anticipates $648.6 million in revenue and $104.2 million in earnings by 2028. This is based on a projected 130.7% annual revenue growth rate and a $584.4 million increase in earnings from current earnings of -$480.2 million.

Uncover how Intellia Therapeutics' forecasts yield a $32.30 fair value, a 156% upside to its current price.

Exploring Other Perspectives

Simply Wall St Community members provided seven fair value estimates for Intellia Therapeutics, ranging from US$16.90 to US$96.81 per share. Against this backdrop of wide disagreement, regulatory and clinical trial delays continue to shape near-term potential and longer-term revenue expectations, so it’s worth weighing several points of view.

Explore 7 other fair value estimates on Intellia Therapeutics - why the stock might be worth just $16.90!

Build Your Own Intellia Therapeutics Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Intellia Therapeutics research is our analysis highlighting 2 key rewards and 2 important warning signs that could impact your investment decision.
• Our free Intellia Therapeutics research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Intellia Therapeutics' overall financial health at a glance.

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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.

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