Arcellx Shares Drop After Patient Death Draws Clinical Hold from FDA

By Dean Seal

Shares of Arcellx are trading lower after regulators put a clinical hold on its investigational new drug for the treatment of relapsed or refractory multiple myeloma following a patient death.

The stock is down 23% at $27.51 in premarket trading. When the market closed Friday, shares had gained 15% since the start of the year and more than doubled over the prior 12 months.

The Gaithersburg, Md.-based company disclosed Monday night that three days earlier, it received a clinical hold for CART-ddBCMA from the U.S. Food and Drug Administration "following a recent patient death."

Arcellx said it believes limitations on bridging therapy were a contributing factor. The company is working with the FDA to expand options for patients that are in line with current clinical practice and has clearance to continue dosing patients who have undergone lymphodepletion.

"The safety and well-being of patients enrolled in our studies is our top priority," said Chief Executive Rami Elghandour. "In coordination with our investigators, data safety monitoring board and our partners at Kite Pharma, we are working with FDA to address the clinical hold."

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

June 20, 2023 06:42 ET (10:42 GMT)

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