Beam Therapeutics Shares Fall Premarket as FDA Puts Study on Hold
01 8월 2022 - 8:22PM
Dow Jones News
By Colin Kellaher
Shares of Beam Therapeutics Inc. slipped more than 10% in
premarket trading on Monday after the biotechnology company said
the U.S. Food and Drug Administration placed its investigational
new drug application for its BEAM-201 program on clinical hold.
The Cambridge, Mass., company said the FDA informed it of the
hold via e-mail on Friday, adding that the agency indicated it will
provide an official letter within 30 days.
According to the FDA's website, subjects can't be given an
investigational drug when a proposed study is placed on clinical
hold. The agency lists several potential reasons for putting an IND
on hold, including the possibility that human subjects "would be
exposed to an unreasonable and significant risk of illness or
injury," or that the application doesn't contain enough information
to assess the risks to subjects of the proposed studies.
Beam, which submitted its application to study BEAM-201 for the
treatment of relapsed/refractory T-cell acute lymphoblastic
leukemia/T cell lymphoblastic lymphoma in late June, said it will
provide further updates pending talks with the FDA.
Beam shares, which closed Friday at $62.98, were recently down
nearly 13% to $55 in light premarket trading.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 01, 2022 07:07 ET (11:07 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
Beam Therapeutics (NASDAQ:BEAM)
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부터 9월(9) 2024 으로 10월(10) 2024
Beam Therapeutics (NASDAQ:BEAM)
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부터 10월(10) 2023 으로 10월(10) 2024
