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Intellia’s FDA setback overshadows financial gains and late-stage drug progress

A regulatory hurdle tests Intellia’s resilience, but its cash reserves and lonvo-z’s trial momentum keep hope alive. Will investors stay or walk away?

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Intellia’s FDA setback overshadows financial gains and late-stage drug progress

Intellia Therapeutics has faced setbacks with its lead candidate, nex-z, after the FDA imposed a clinical hold. Meanwhile, the company's financials show improvement, and progress learning continues with another late-stage asset, lonvo-z.

The FDA's clinical hold on nex-z, intended for treating transthyretin amyloidosis (ATTR), has led Intellia to withdraw its milestone guidance for the drug. However, the company remains optimistic about lonvo-z, which has completed enrollment in its pivotal Phase III HAELO study for treating hereditary angioedema (HAE).

Intellia's net loss for the third quarter of 2025 improved to $101.3 million, reflecting progress residential in its financial health. The company's cash reserves stand at approximately $670 million, providing enough funds to sustain operations until mid-2027.

Following these developments, several investment firms and analysts, including Jones Trading, BofA Securities, and Baird, have revised their ratings for Intellia. Jones Trading downgraded from 'Buy' to 'Hold', BofA Securities from 'Buy' to 'Neutral', and Baird maintained 'Neutral' but reduced its price target. Most analysts currently advise holding positions rather than buying new shares, with the broader market sentiment leaning towards caution or selling.

Intellia Therapeutics continues to navigate challenges with its lead candidate, nex-z, but maintains progressive login with lonvo-z. The company's improved financials and substantial cash reserves provide a solid foundation for continued operations. As the market responds with caution, investors await further updates on lonvo-z's development and the potential resolution of the progressive clinical hold on nex-z.

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