Orphan Drug Status

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MBIO Soars on Orphan Drug Nod for Investigational Brain Cancer Therapy
ZACKSยท 2025-07-08 15:41
Key Takeaways MBIO's MB-101 received FDA Orphan Drug status for astrocytomas and glioblastoma treatment. The CAR-T cell therapy showed durable responses in the phase I GBM study, including 2 complete responses. MBIO plans a 2026 phase I study of MB-109, a combo of MB-101 and MB-108, pending financing or partnership.Shares of Mustang Bio (MBIO) skyrocketed 180.7% on Monday after the company announced that the FDA granted Orphan Drug designation to its investigational candidate, MB-101, which is being devel ...