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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Allogeneic gene edited BCMA-directed CAR T cells
Trade Name:  N/A
Date Designated:  12/18/2019
Orphan Designation:  Treatment of multiple myeloma
Orphan Designation Status:  Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Marketing Approval Date:  N/A
Approved Labeled Indication:  
Exclusivity End Date:    N/A
Precision BioSciences, Inc.
302 East Pettigrew Street
Suite A-100
Durham, North Carolina 27701

The sponsor address listed is the last reported by the sponsor to OOPD.