Arcellx Shares Drop After Patient Death Draws Clinical Hold from FDA
20 Juin 2023 - 12:57PM
Dow Jones News
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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