FDA Places Formal Hold on Two Intellia CRISPR Trials

FDA places formal hold on two Intellia CRISPR trials

Two days after Intellia voluntarily paused dosing due to safety concerns, the regulator stepped in with an official hold that makes a longer halt more likely.

FDA puts two Intellia CRISPR trials on hold following liver toxicity case

The FDA suspended two of Intellia Therapeutics’ clinical trials of a gene editing treatment for transthyretin amyloidosis, or ATTR, a disease in which misfolded proteins build up in the heart or nerves and cause damage ...

US FDA places clinical hold on Intellia's gene therapy trials; shares fall

The U.S. Food and Drug Administration has placed a clinical hold on Intellia Therapeutics’  two late-stage trials testing an experimental gene therapy for a rare disease that can damage the heart and nerves, the company said on Wednesday. Shares of the Cambridge-based company fell about 17 per cent in extended trading. The FDA’s decision follows a serious safety event in one of the trials, where a patient who received the therapy, called nexigur…

US FDA places clinical hold on Intellia’s gene-editing treatment trials; shares fall - Regional Media News

(Reuters) -Intellia Therapeutics said on Wednesday that the U.S. Food and Drug Administration has placed a clinical hold on its two late-stage trials testing an experimental gene-editing therapy for a rare disease that can damage the heart and nerves. Shares of the company fell about 14% in extended trading. Earlier this week, the company said that in one of its gene-editing trials a patient who received the therapy, called nexiguran ziclumeran …