Intellia Stock Declines Around 55% in 3 Months: Here's Why

Core Viewpoint - Intellia Therapeutics has faced a significant decline in share price due to regulatory setbacks related to its lead pipeline candidate, nexiguran ziclumeran (nex-z), which is being developed for treating ATTR amyloidosis [2][4] Group 1: Regulatory and Clinical Developments - Intellia temporarily halted dosing and patient enrollment in its late-stage MAGNITUDE and MAGNITUDE-2 studies after a patient experienced severe liver complications leading to death [3] - The FDA imposed a clinical hold on the investigational new drug applications for nex-z, raising concerns about the safety and future of the program [4] - Intellia has suspended its milestone guidance for nex-z and is collaborating with investigators and regulators to address the issues and develop risk-mitigation strategies [4][6] Group 2: Financial Performance - Intellia's third-quarter results showed mixed performance, with total revenues of $13.8 million, slightly missing estimates [9] - The company reported a loss of 92 cents per share, which was narrower than the Zacks Consensus Estimate of a loss of $1.02 [9] - Intellia's revenue is solely dependent on collaboration revenues from partners like Regeneron Pharmaceuticals, which dampens investor confidence due to the lack of a marketed product [10] Group 3: Future Prospects - The setbacks concerning nex-z have created uncertainty over the timeline and approval chances for Intellia's other candidate, lonvoguran ziclumeran (lonvo-z), which is being developed for hereditary angioedema [7] - Intellia completed patient enrollment in the pivotal phase III HAELO study for lonvo-z in September 2025, with top-line data expected by mid-2026 and a potential U.S. commercial launch in the first half of 2027 [8]