Beam Therapeutics Gets Details of FDA Hold on BEAM-201 Studies
August 30 2022 - 8:17AM
Dow Jones News
By Colin Kellaher
Beam Therapeutics Inc. on Tuesday said the U.S. Food and Drug
Administration has made several requests related to the agency's
clinical hold on the biotechnology company's investigational new
drug application for its BEAM-201 program.
The Cambridge, Mass., company, which was informed in late July
via email of the clinical hold, said it has now received a formal
letter from the FDA in which the agency asked for additional
control data from genomic rearrangement assessments, further
analyses of certain off-target editing experiments, additional
control data for a cytokine independent growth assay and an updated
investigator brochure that includes information regarding any new
nonclinical studies.
Beam, which plans to study BEAM-201 for the treatment of
relapsed/refractory T-cell acute lymphoblastic leukemia/T cell
lymphoblastic lymphoma, said it intends to complete the required
studies and submit a complete response to the FDA in the fourth
quarter.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 30, 2022 08:02 ET (12:02 GMT)
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