Mustang Bio Gets FDA Orphan Drug Designation for MB-108 in Malignant Glioma Treatment

MT Newswires Live11-08

Mustang Bio (MBIO) said Thursday that MB-108, an oncolytic virus currently undergoing phase 1 clinical trial for malignant glioma treatment, has been granted orphan drug designation by the US Food and Drug Administration.

The designation provides MB-108 seven years of market exclusivity in the US for the treatment.

Mustang also said it plans to seek orphan drug designation from the FDA for MB-101, an investigational CAR-T cell therapy for malignant gliomas.

The company said its novel strategy is to combine MB-108 oncolytic virus with MB-101 CAR-T cell therapy to optimize clinical results. It said both MB-101 and MB-108 are well tolerated in patients with recurrent glioblastoma, a type of brain tumor.

Shares of Mustang Bio were up more than 3% in recent trading.

Price: 0.25, Change: +0.01, Percent Change: +3.33

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