Intellia Therapeutics (NASDAQ:NTLA) shares gained 4.8% to $14.44 in premarket trading on Monday after the company announced that the U.S. Food and Drug Administration had lifted a clinical hold affecting a late-stage study of its experimental gene-editing therapy for heart disease.
The regulator had previously halted two pivotal trials of nexiguran ziclumeran last year following the death of a participant linked to severe liver complications.
In January, the FDA cleared one of those studies — MAGNITUDE-2 — to resume after Intellia introduced additional safety measures. These included stricter monitoring of liver-related laboratory markers and excluding patients with certain pre-existing liver conditions.
The investigational treatment is being evaluated in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), a progressive and life-threatening disorder caused by abnormal protein deposits that stiffen the heart muscle and impair its ability to pump blood effectively.