By Chris Wack

Mustang Bio shares more than quadrupled, to $5.23, after the company on Monday said the Food and Drug Administration granted orphan drug designation to Mustang for MB-101 for the treatment of recurrent diffuse and anaplastic astrocytoma and glioblastoma.

The stock hit its 52-week low of 89 cents on July 1, and is down nearly 80% in the past 12 months.

The FDA grants orphan drug designation to drugs and biologics that are intended for safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S.

Orphan drug designation provides certain incentives, such as tax credits toward the cost of clinical trials upon approval and prescription-drug user-fee waivers. If a product receives the status, that product is entitled to seven years of market exclusivity for the disease in which it has the designation, which is independent from intellectual-property protection.

The Waltham, Mass., biopharmaceutical company said its ability to further develop the program for recurrent GBM and high-grade astrocytomas is contingent upon raising additional funding or consummating a strategic partnership.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

July 07, 2025 11:14 ET (15:14 GMT)

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