Beam Therapeutics Gets Details of FDA Hold on BEAM-201 Studies

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 [e-mail]

(END) Dow Jones Newswires

August 30, 2022 08:02 ET (12:02 GMT)

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