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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: autologous T cells expressing an anti delta like ligand 3 (DLL3) targeting chimeric antigen receptor (CAR) and a caspase recruitment domain containing protein 11 phosphoinositide 3 kinase regulatory subunit 3 (CARD11 PIK3R3) fusion protein
Date Designated: 06/22/2026
Orphan Designation: treatment of small cell lung cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Moonlight Bio, Inc.
1150 Eastlake Ave E, Suite 500
Seattle, Washington 98109
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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