Mustang Bio Inc. Secures FDA Orphan Drug Designation for MB-101 to Treat Astrocytomas and Glioblastoma

Reuters
09 Jul
Mustang Bio Inc. Secures FDA Orphan Drug Designation for MB-101 to Treat Astrocytomas and Glioblastoma

Worcester, MA - July 7, 2025 - Mustang Bio, Inc., a clinical-stage biopharmaceutical company, announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its MB-101 (IL13Ra2-targeted CAR T-cells) therapy. This designation is for the treatment of recurrent diffuse and anaplastic astrocytoma and glioblastoma (GBM). Previously, the FDA also granted Orphan Drug Designation for Mustang's MB-108 for the treatment of malignant glioma. This recognition validates Mustang Bio's innovative approach, which combines MB-101 and MB-108 to potentially improve treatment outcomes for patients with challenging cancers. The development of the MB-109 program for recurrent GBM and high-grade astrocytomas will depend on securing additional funding or strategic partnerships.

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