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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: a non-replication recombinant adeno-associated virus (AAV) serotype ATC-0187 capsid, containing a full length human BAG3 complementary deoxyribonucleic acid (cDNA) coding for BAG3 protein
Date Designated: 07/16/2026
Orphan Designation: treatment of dilated cardiomyopathy due to mutations in the BAG3 gene
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Affinia Therapeutics
43 Foundry Ave
Suite 120
Waltham, Massachusetts 02453
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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