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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: antibody drug conjugate composed of a humanized monoclonal antibody targeting MUC1-C and linker payload 7B8-exatecan
Date Designated: 06/16/2026
Orphan Designation: treatment of gastric cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Xyone Therapeutics, Inc.
780 Dedham Street
Suite 800
Canton, Massachusetts 02021
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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