Intellia stock tumbles after pausing gene therapy trials on safety concerns

Investing.com -- Intellia Therapeutics (NASDAQ: NTLA) stock tumbled 50% Monday after the company announced it has temporarily paused patient dosing and screening for its Phase 3 clinical trials of nex-z due to a serious liver safety event. CRISPR Therapeutics (NASDAQ: CRSP) shares also fell 10% following the news.

The gene editing company halted its MAGNITUDE and MAGNITUDE-2 trials for patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and polyneuropathy (ATTR-PN), respectively. The decision came after a patient dosed with nex-z in the MAGNITUDE trial on September 30 reported Grade 4 liver transaminases and increased total bilirubin on October 24, meeting protocol-defined pausing criteria.

"In line with our commitment to patient safety, we have taken immediate action to temporarily pause enrollment in MAGNITUDE and MAGNITUDE-2 as we investigate this recent event," said Intellia President and Chief Executive Officer John Leonard, M.D. "As we focus on ensuring the health of this patient, we also are engaging with regulatory authorities and other stakeholders globally to develop a strategy to resume enrollment as soon as appropriate."

The affected patient was hospitalized and is currently receiving medical intervention while being closely monitored. Intellia is consulting with experts, considering potential risk mitigation strategies, and engaging with regulatory authorities.

Prior to the pause, the MAGNITUDE trial had enrolled more than 650 patients with ATTR-CM, while MAGNITUDE-2 had enrolled 47 patients with ATTR-PN. Approximately 450 of these patients are estimated to have been dosed with nex-z.

The safety concerns have rippled through the gene editing sector, affecting other companies like CRISPR Therapeutics that utilize similar technology platforms.

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