Why Did NTLA Stock Tumble 43% Pre-Market Today?

• Intellia said that it has temporarily paused patient dosing and screening for two of its late-stage trials for Nex-z.
• The decision follows a report on October 24 of heightened liver transaminases and increased total bilirubin in a patient who was dosed with Nex-z in a trial.
• The patient is being closely monitored and receiving medical intervention, the company said.
   

Intellia Therapeutics, Inc. (NTLA) on Monday said that it has temporarily paused patient dosing and screening for two of its late-stage trials for Nex-z after a patient was hospitalized.

The company has paused dosing in a trial that enrolled patients with transthyretin amyloidosis with cardiomyopathy and another that enrolled patients with polyneuropathy. Transthyretin amyloidosis with cardiomyopathy is a severe and progressive heart failure caused by the buildup of misfolded amyloid fibrils, derived from the transthyretin protein, in the heart muscle. Transthyretin amyloidosis with polyneuropathy, meanwhile, is a progressive, multisystem disease caused by the buildup of abnormal proteins in the body's organs and tissues. 

Why The Pause?

The decision follows a report on October 24 of heightened liver transaminases and increased total bilirubin in a patient who was dosed with Nex-z in a trial, raising concerns of drug-induced liver injury. The patient was dosed with Nex-z on September 30.

The hospitalized patient is being closely monitored and receiving medical intervention, the company said.

What Are The Company’s Plans?

Meanwhile, the company said it is consulting with experts, considering potential risk mitigation strategies, and engaging with regulatory authorities.

“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. 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.” 
– John Leonard, CEO, Intellia Therapeutics

Nex-z or Nexiguran Ziclumeran is a therapy based on gene editing technology. It is designed to inactivate the TTR gene that encodes the transthyretin protein. As of Monday, more than 700 patients have been enrolled in the two trials in which Intellia has paused dosing, and over 450 have already been dosed with Nex-z.

Shares of the company slumped 43% in the pre-market session at the time of writing. On Stocktwits, retail sentiment around NTLA stock soared from ‘bearish’ to ‘bullish’ territory over the past 24 hours, while message volume increased from ‘low’ to ‘high’ levels.

NTLA stock has more than doubled this year and gained about 57% over the past 12 months. 

Read also: BBIO Stock Soars After Experimental Drug Shows Improvement In Inherited Muscle Disorder In Late-stage Trial

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