Another issue for them long-term is the fact they will add an anti-CD52 mAb, which causes profound lymphodepletion, or being able to overcome host rejection.
It turns out that the FDA's concerns about BEAM's BEAM-201 are multi-faceted, with the agency requesting ''additional control data from genomic rearrangement assessments'' and ''further analyses of certain off-target editing experiments.'' In addition, the agency is also looking for more control data for a ''cytokine-independent growth assay'' and ''updated investigator brochure that includes information regarding any new nonclinical studies.'' The company has guided to a response submission in Q4.
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