Clinical-stage biotech firm Mustang Bio (NASDAQ:MBIO) stock rallied 180% on Monday to £2.46 ($3.34) per share after the US Food and Drug Administration granted Orphan Drug Designation to its MB-101 drug candidate for the treatment of recurrent diffuse and anaplastic astrocytoma and glioblastoma, two types of fast-growing brain tumours.
The FDA grants this designation to drugs intended for safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. The drug status offers several incentives, like tax credits toward clinical trials costs upon approval and prescription drug user fee waivers. Furthermore, the orphan drug status means the drug candidate is entitled to seven years of market exclusivity for the disease in which it has the designation. Overall, the designation offers the company multiple strategic advantages in the development and commercialisation of its therapies.
