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Intellia Therapeutics Inc (NASDAQ:NTLA) shares are tumbling in after-hours trading on Wednesday after the company announced the U.S. Food and Drug Administration (FDA) placed a clinical hold on some of its Investigational New Drug (IND) applications.
What To Know: Intellia said the FDA verbally informed the company of the clinical hold on its IND applications for the MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials for nexiguran ziclumeran.
The news comes after Intellia shares plunged on Monday after the company disclosed a report of Grade 4 liver transaminases and increased total bilirubin in a patient who was dosed with nexiguran ziclumeran in the MAGNITUDE trial.
Intellia said at the beginning of the week that it was temporarily pausing patient dosing and screening for its MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials as a result.
“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,” Intellia president and CEO John Leonard said in a statement on Monday.
Intellia said Wednesday that the FDA plans to provide a formal clinical hold letter within 30 days. The company intends to work with the FDA to address the clinical hold “as expeditiously as possible.”
NTLA Price Action: Intellia Therapeutics shares were down 16.16% in after-hours, trading at $11 at the time of publication on Wednesday, according to Benzinga Pro. The stock was trading near 52-week highs on Monday before the company provided an update on the MAGNITUDE trial.
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Posted In: NTLA
