Mustang Bio Shares Surge After FDA Grants Orphan Drug Designation for Brain Cancer Therapy

Mustang Bio's shares surged over 78% following the FDA's granting of Orphan Drug Designation for its MB-101 CAR T-cell therapy, targeting recurrent diffuse and anaplastic astrocytoma and glioblastoma, rare and aggressive brain cancers. This designation provides the company with financial incentives such as tax credits, waiver of prescription drug user fees, and seven years of market exclusivity upon approval. Phase 1 clinical trials have shown promising results, with 50% of patients achieving stable disease or better, including two complete responses lasting over 7.5 and 66+ months. Mustang Bio is also developing a combination therapy, MB-109, which combines MB-101 with MB-108, an oncolytic virus treatment designed to increase the effectiveness of the CAR T-cell therapy by converting cold tumors into hot tumors. The company’s progress depends on securing additional funding or strategic partnerships to further develop these programs. Analysts have responded positively, with Mustang Bio holding an 'Outperform' rating and a consensus target price suggesting substantial upside from current levels.