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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: bispecific humanized IgG4 BCMA-directed CD3 T cell engager antibody
Date Designated: 12/04/2025
Orphan Designation: treatment of immune thrombocytopenia (ITP)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Lakefront Biotherapeutics West LLC
701 Gateway Boulevard, Unit 410
South San Francisco, California 94080
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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