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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: recombinant anti-GPRC5D/BCMA/CD3 trispecific IgG1 antibody
Date Designated: 05/08/2026
Orphan Designation: treatment of multiple myeloma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Fortvita Biologics
950 Page Mill Rd, Suite 204
Palo Alto, California 94304
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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