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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 humanized IgG1kappa-agonistic anti-CD40 mAb
Date Designated: 08/03/2021
Orphan Designation: Treatment of patients with Soft Tissue Sarcoma (STS).
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Pyxis Oncology, Inc.
321 Harrison Avenue
11th Floor, Suite 1
Boston, Massachusetts 02118
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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