East Coast, USA-based cell and gene therapy specialist Mustang Bio (Nasdaq: MBIO) has been granted Rare Pediatric Disease designation for MB-107 by the US Food and Drug Administration.
The designation means that a Priority Review Voucher (PRV) will be issued should the submission be approved for the treatment of X-linked severe combined immunodeficiency (X-SCID), also known as “bubble boy disease”.
A PRV grants a rapid half-year review timeframe for any subsequent submission for regulatory approval, and can be sold on to other firms. In the past, PRVs have been traded for as much as $300 million.
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