Beam announces FDA formal clinical hold letter for BEAM-201 IND; plans Q4 2022 response

Beam Therapeutics Inc.

FDA placed BEAM-201 IND on clinical hold for relapsed/refractory T-ALL/T-LBL.
Letter dated Aug 25 requests additional control data and off-target editing analyses.
Requests also include additional cytokine assay data and updated investigator brochure.
Beam intends to complete studies and submit Complete Response in Q4 2022.

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