US EditionE2 (Endovascular Engineering, Inc) Presents ENGULF Pivotal Study as a Late-Breaking Clinical Trial at the VIVA Conference
Intellia paused dosing in global Phase III trials of nexiguran ziclumeran due to liver safety signals meeting Hy's law; FDA imposed a clinical hold on the studies.
- On October 27, Intellia Therapeutics voluntarily paused dosing and screening in MAGNITUDE and MAGNITUDE-2, while the FDA imposed clinical holds on the trials' INDs, the company reported.
- A hospitalized patient experienced Grade 4 liver transaminase elevations meeting Hy's law after dosing with nex-z on September 30, Intellia reported 24 days later.
- As a program, nex-z had already dosed more than 450 patients across MAGNITUDE and MAGNITUDE-2, two of three Phase III studies with MAGNITUDE expected to enroll at least 650 patients by end of 2025.
- Multiple firms downgraded Intellia Therapeutics shares this past week, with the stock plunging 42% following the October 27 dosing pause and subsequent declines to $12.27.
- With the hold in place, the FDA will have 30 days to review Intellia Therapeutics' response, and analysts expect delays in the MAGNITUDE-2 schedule and BLA submission in second half of 2026.
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The Billings Gazette
Late-Breaking Clinical Trial Results Announced at The VEINS 2025
LAS VEGAS, Nov. 2, 2025 /PRNewswire/ -- The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine through education and research, today announced results from the Late-Breaking Clinical Trials presented at The VEINS 2025 conference, held…
StockWatch: Intellia Shares Sink as Clinical Hold Follows Safety Setback
John Leonard, MD, Intellia Therapeutics president and CEO Addressing analysts in August, Intellia Therapeutics (NASDAQ: NTLA) president and CEO John Leonard, MD, announced that, given greater-than-expected patient enrollment in a Phase III trial assessing nexiguran ziclumeran (nex-z) in transthyretin amyloidosis with cardiomyopathy (ATTR-CM), the company would increase enrollment to approximately 1,200 patients. “We expect that we will enroll mo…
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