Mustang Bio's MB-107 gets EMA PRIME designation for 'bubble boy disease'

USA-based cell and gene therapy specialist Mustang Biotech’s (Nasdaq: MBIO) shares edged up 1.4% to $2.83 in after-hours trading, following the0 announcement that the European Medicines Agency has granted Priority Medicines (PRIME) designation to MB-107, its lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (XSCID) in newly diagnosed infants, also known as bubble boy disease.

In addition to PRIME designation, the EMA granted Advanced Therapy Medicinal Product (ATMP) classification to MB-107 in April 2020 and Orphan Drug designation in November 2020. MB-107 has also received Orphan Drug, Rare Pediatric Disease and Regenerative Medicine Advanced Therapy (“RMAT”) designations from the US Food and Drug Administration.

“Exciting milestone” for Mustang