MBIO - Mustang Bio gets EMA Priority Medicines status for bubble boy disease treatment

Mustang Bio (NASDAQ:MBIO) announces that the European Medicines Agency (EMA) has granted Priority Medicines (“PRIME”) designation to MB-107 for the treatment of X-linked severe combined immunodeficiency (“XSCID”) in newly diagnosed infants, also known as bubble boy disease. MB-107 has also received Orphan Drug, Rare Pediatric Disease and Regenerative Medicine Advanced Therapy (“RMAT”) designations from the U.S. FDA. The PRIME program aims to optimize development plans and speed up evaluation of promising medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. It also provides a pathway for accelerated assessment of an Marketing Authorization Application under the centralized procedure.

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Mustang Bio gets EMA Priority Medicines status for bubble boy disease treatment