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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: human cord blood-derived stem cells expanded by exposure to yolk sac microenvironment
Date Designated: 07/11/2025
Orphan Designation: treatment to enhance cell engraftment in patients receiving hematopoietic stem cell transplant
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
HeXem Bio, Inc.
877 Francisco St, Unit 1001,
Los Angeles, California 90017
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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